In an attempt to broaden our industry coverage I recently started a more comprehensive Pharma & Biotech monthly update. See Pharma & Biotech Update: News for September 2013.
What follows below is a review of some of the biotech and pharma news stories that caught my attention during the month of October 2013. I also wrote a couple of other articles for the Patent Practice Center that could be listed here as well. See Forest Labs sues over Generic Version of SAVELLA® and FDA Designates Orphan Drugs Status for Rare Diseases.
Without further ado, here is the rundown for October 2013.
- Surgeons Successfully Remove “Inoperable” Metastatic Breast Cancer
- Actavis Files ANDA on Acanya® Gel, Gets Sued by Dow, Valeant
- NYSE Inquires About Unusual Market Activity for Ampio Pharmaceuticals
- Shang Pharma Appoints Dr. Arthur Taveras President and CSO
- Cannabis Biotech Hires Patent Attorney to Protect Medical Marijuana Innovation
- Merck’s Hepatitis C Drug Gets Breakthrough Therapy Designation
- Therapeutic Vaccine for Hepatitis C Enters Phase I
- Urine Test for Cancer Monitoring
- Popular Prenatal Vitamin Patent Upheld in District Court
- Clinical Trials on Brain Technology to Assist ALS Patients
- Patent Awarded to Human Growth Hormone Booster
- Mouse Model of Parkinson’s Disease Shows Improved Brain Function
- DARPA Awards $25 Million To Develop Messenger RNA Therapeutics™
- Actavis Files ANDA for Generic Suboxone® Sublingual Film
- AzaSite® Patents Upheld in Patent Infringement Lawsuit Against Sandoz
- Innovative Cancer Treatment Wins Global Design Competition
- Teva Gets Favorable Ruling on COPAXONE in the Netherlands
- BVGH Recruits Dr. Linda Venczel as New Program Director
- Actavis’s settles with FTC over $8.5 Billion acquisition of Warner Chilcott
1. Surgeons Successfully Remove “Inoperable” Metastatic Breast Cancer
A surgical team at Temple University Hospital, Philadelphia, Pa., recently performed a groundbreaking procedure on a patient who had previously been diagnosed with inoperable metastatic Stage 4 Breast cancer, using the Canady Vieira Hybrid Plasma™ (CVHP) Scalpel developed and sold by US Medical Innovations, LLC (USMI). The CVHP™ Scalpel is an advanced electrosurgical plasma device utilizing Hybrid Plasma Technology. It is being touted as a revolutionary patent pending energy beam that simultaneously cuts and coagulates biological tissues.
The multidisciplinary team of doctors and scientists from multiple medical centers collaborated over a nine-month period to design a treatment plan consisting of preoperative chemo and radiation therapy, along with computerized mapping of the surgical procedure via the CT scan.
After successful cytoreduction (shrinkage) of the tumor from the breast, chest wall and liver, staged surgical procedures were performed. The breast tumor was removed in July of 2013 by Robert Dewitty, M.D., surgical oncologist at Providence Hospital, Washington, DC. In September of 2013, Andreas Karachristos, M.D., Ph.D., Chief of Hepatobiliary Surgery, and Abbas El-Sayeh Abbas, M.D., Chief of Thoracic Surgery successfully removed the tumor from the chest wall and liver at Temple University Hospital, in Philadelphia, Pa.
2. Actavis Files ANDA on Acanya® Gel, Gets Sued by Dow, Valeant
Actavis plc (NYSE: ACT) confirmed on October 28, 2013, that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%. Actavis’ ANDA product is a generic version of Dow Pharmaceutical Sciences and Valeant Pharmaceuticals International’s Acanya® Gel, which is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
Dow Pharmaceutical Sciences, Inc. and Valeant Pharmaceuticals North America LLC filed suit against Actavis on October 24, 2013, in the U.S. District Court for the District of New Jersey seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of U.S. Patent No. 8,288,434. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the 12 months ending July 31, 2013, Acanya® had total U.S. sales of approximately $62 million, according to IMS Health data.
The Road Forward: Software Patents in the Post-Alice Market
Join Gene Quinn and Scott Alter for a discussion on patent eligibility, techniques for claiming software, prosecution strategies and more. Wednesday, March 4, 2015 at 12pm ET ~ CLICK HERE to REGISTER
3. NYSE Inquires About Unusual Market Activity for Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. (NYSE: AMPE) announced on October 25, 2013, that it was contacted by the New York Stock Exchange in light of unusual market activity in the Company’s common stock, which occurred on Thursday, October 24, 2013. In accordance with the New York Stock Exchange’s usual practice, the Company announced that its policy is not to comment on unusual market activity. Notwithstanding, Ampio did summarize several milestones achieved over the past ten weeks including:
- Positive results for Ampion in osteoarthritis of the knee clinical trial
- $25 million financing
- Positive summary data from Luoxis Diagnostics’ study of traumatic brain injury patients and issuance of company’s third US patent for its oxidation-reduction potential diagnostic platform
- Positive results from Independent Panel Review of the interim analysis of the Optina trial for diabetic macular edema
4. Shang Pharma Appoints Dr. Arthur Taveras President and CSO
ShangPharma Corporation announce on October 25, 2013, that Dr. Art Taveras will join the company as President and Chief Scientific Officer (CSO).
Prior to joining ShangPharma, Dr. Taveras was Vice President Small Molecules Drug Discovery, Vice President Chemistry R&D, and Vice President CMC Development at Biogen Idec, leading the discovery and CMC development of neurology, immunology and oncology drug candidates at its multiple sites and partnerships in the U.S. and abroad. Before Biogen Idec, Dr. Taveras was Vice President of Drug Discovery and CMC Development at Alantos Pharmaceuticals, leading the company’s discovery research and building its Diabetes and Matrix Metalloproteinase franchise in the U.S. and Germany before being acquired by Amgen in 2007. Dr. Taveras began his career with Schering-Plough Corporation, where he spent 14 years in Oncology and Immunology Drug Discovery Research, after receiving his Ph.D. degree with Professor A. Schultz at Rensselaer Polytechnic Institute.
5. Cannabis Biotech Hires Patent Attorney to Protect Medical Marijuana Innovation
Puget Technologies (OTCBB:PUGE) announced on October 23, 2013, that its subsidiary, Cannabis Biotech, has entered into an agreement with an unidentified patent attorney to seek patent protection for a transmucosal system for the delivery of medical marijuana. Cannabis Biotech is reportedly developing a platform with the ability to deliver a reliable, standard dose of medicine. The company says that a transmucosal platform is an effective means to introduce treatments across the mucous membrane and is an accepted system of administration.
President and CEO of Puget Technologies Ron Leyland said, “Cannabis Biotech will be filing a design patent for a unique delivery device to optimize administration of the medicine and improve effectiveness and outcomes.” He added, “The intranasal system will position Cannabis Biotech to take advantage of market growth and play a significant role in the future of medical marijuana development and commercialization.”
I doubt that Puget Technologies will be filing a design patent as Leyland suggests above. Design patents do not protect functionality at all, but rather protect only the ornamental appearance of a product. A utility patent would protect the delivery device assuming it is new and non-obvious.
6. Merck’s Hepatitis C Drug Gets Breakthrough Therapy Designation
On October 22, 2013, Merck (NYSE:MRK) announced today the U.S. Food and Drug Administration (FDA) has granted MK-5172/MK-8742 Breakthrough Therapy designation for treatment of chronic hepatitis C virus infection. The designation of an investigational drug as a Breakthrough Therapy is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
“The designation of MK-5172/MK-8742 as a Breakthrough Therapy for chronic hepatitis C is an important milestone for Merck,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “There remains significant unmet medical need in hepatitis C, and we are looking forward to working with the FDA to advance this program as quickly as we can to bring this investigational combination to HCV specialists and their patients.”
MK-5172/MK-8742 is an all-oral combination regimen consisting of MK-5172, an investigational HCV NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor.
7. Therapeutic Vaccine for Hepatitis C Enters Phase I
On October 21, 2013, Inovio Pharmaceuticals, Inc. (NYSE: INO) announced that the safety, tolerability and immunogenicity of its therapeutic vaccine for hepatitis C (INO-8000/VGX-6150) will be studied in a phase I clinical trial in chronically HCV infected patients who have previously failed standard drug therapies. Under a 2011 collaborative development agreement, Inovio’s affiliate, VGX International Inc., is fully funding and conducting the study at multiple sites in Korea. Inovio is also planning to evaluate this hepatitis C (HCV) vaccine in additional clinical studies in the U.S. beginning in 2014.
This study is a multi-center, open-label, dose-escalating phase I trial in which 18 subjects will be divided into three groups and given four monthly vaccinations of 1 mg, 3 mg and 6 mg doses of VGX-6150, respectively. Individuals with chronic HCV who failed previous standard of care therapy with pegylated interferon and ribavirin or triple therapy with standard of care and direct-acting antiviral agents such as boceprevir or telaprevir will be enrolled. Both immunogenicity and virologic response will be evaluated in addition to the safety and tolerability of VGX-6150.
8. Urine Test for Cancer Monitoring
On October 21, 2013, Trovagene Inc. (NASDAQ: TROV) announced study findings demonstrating that the company’s non-invasive oncogene mutation detection technology can be a clinically useful cancer-monitoring tool. In collaboration with scientists at Trovagene, Dr. Filip Janku of The University of Texas MD Anderson Cancer Center presented findings from an ongoing clinical study of Trovagene’s technology at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA.
“These data suggest that monitoring key oncologic mutations in cell-free DNA from urine may offer a non-invasive and reliable alternative to mutation testing of tumor tissue,” said Dr. Janku, from the Department of Investigational Cancer Therapeutics at MD Anderson. “Trovagene’s technology opens the possibility of a new, non-invasive method for quantifying mutational tumor load, monitoring therapeutic response, and detecting genomic alterations that can lead to therapeutic resistance in individual patients.”
During the study, urine samples from metastatic cancer patients known to have BRAF V600E, KRAS G12D or KRAS G12V mutations were assessed. Researchers at Trovagene analyzed the urine samples using Trovagene’s urine-based cell-free DNA mutation assays.
Researchers observed high concordance between urine and tissue mutational status. In addition, preliminary results indicate that cell-free BRAF V600E mutation monitoring in urine correlates with clinical response to therapy.
9. Popular Prenatal Vitamin Patent Upheld in District Court
Mission Pharmacal Company recently announced that a federal district court inTexas upheld its patent that covers one of the nation’s most prescribed prenatal vitamin brands. U.S. Patent No. 6,521,247, titled Dual iron containing nutritional supplement, covers its popular CitraNatal® family of prenatal vitamins, and was successfully asserted against PureTek Corporation.
“The U.S. Patent and Trademark Office confirmed the validity of the ‘247 patent during a reexamination and this ruling reconfirms that validity,” Cusenbary says. The patent protects CitraNatal’s use of a specific combination of iron that combats iron deficiency anemia before, during, and after pregnancy.
This is the second time Mission Pharmacal has successfully asserted this patent. In 2010, another generic manufacturer agreed that it had violated the patent and took its product off the market.
“We have successfully asserted the ‘247 patent in the past, and will continue to protect the patented formulation incorporated in CitraNatal Assure®, CitraNatal® 90 DHA, and CitraNatal B-Calm®, as well as Mission’s Ferralet® 90 prescription iron supplement, with equal vigor against any generic intrusion,” adds Cusenbary.
10. Clinical Trials on Brain Technology to Assist ALS Patients
A new technology that will enable patients suffering from ALS — commonly known as Lou Gehrig’s Disease — to communicate via brain monitor, will hold its first clinical trials in Philadelphia. The announcement came days after Congressman Chaka Fattah and Dr. Philip Low, who patented the device, met in Fattah’s Capitol Hill office to discuss future opportunities to partner around neuroscience, and encourage investment in brain technology in the United States, particularly in Fattah’s Pennsylvania district.
Dr. Low, founder and CEO of NeuroVigil, a San Diego-based company, has also filed a patent for a new brain monitor— the world’s smallest yet. Low has developed other technologies using the monitor to test on patients in various stages of ALS, including the iBrain—a portable neural device that monitors and diagnoses brain conditions
In addition to the clinical trials starting in Philadelphia, a satellite research laboratory will operate from NASA’s Research Park in Mountain View, CA, and will allow Dr. Low to continue developing the assistive technologies before starting trials for the new technology.
11. Patent Awarded to Human Growth Hormone Booster
The United States Patent Office has issued a U.S. Patent for an oral growth hormone booster that has reportedly been clinically validated to raise mean, serum (blood) hGH levels by 682%. It is being billed as anti-aging formula.
U.S. Patent Number 8,551,542, titled Methods and compositions for increasing growth hormones, issued on October 8, 2013 to Basic Research, LLC, and relates generally to methods and supplements for improving the health of human beings without requiring injections.
The Summary of the Invention explains:
Some embodiments include a method for increasing growth hormone (e.g., hGH) in a subject (e.g., a human subject) that comprises orally administering a nutritional supplement to a subject to improve one or more objective health metrics, including for example and without limitation: increasing lean body mass; reducing obesity, adipose tissue mass, and anxiety; supporting weight loss; decreasing appetite and atrophic processes in skeletal muscle, liver, kidney, spleen, skin, and bone; and improving at least one of energy, endurance, sleep, metabolism, heart rate, blood pressure, cardiovascular health, sympathetic nervous activity, thyroid response, glucose utilization, mental/cognitive function, reaction time, bone density, hair health and appearance, nail health and appearance, skin health and appearance, and libido.
The supplement, marketed now as SeroVital™, allegedly makes it possible for people to increase their human growth hormone levels without hGH injections. “Rather than introducing synthetic hGH into the body via injections, SeroVital increases the body’s own, endogenous levels of human growth hormone by promoting pituitary health, the gland that manufactures hGH,” says Dr. Amy Heaton, PhD, Director of Scientific Affairs for SanMedica International, which is the company that markets SeroVital™.
12. Mouse Model of Parkinson’s Disease Shows Improved Brain Function
A paper published in the Journal of Neuroimmune Pharmacology shows that Revalesio’s therapeutic RNS60 significantly improved biochemical and behavioral outcomes in a mouse model of Parkinson’s disease. According to the Michael J. Fox Foundation, Parkinson’s disease is the most common neurodegenerative condition, afflicting 1 in 100 people over age 60.
The model used in the study generates Parkinson’s-like symptoms through targeting dopaminergic neurons in the substantia nigra pars compacta, a region of the brain involved in controlling movement. The experiments demonstrated that treatment with RNS60 restored dopamine and provided a significant level of protection against neuronal death. In addition to protecting the brain from the biochemical damage associated with Parkinson’s, RNS60 also preserved the motor function of the animals.
The research was conducted by the laboratory of Dr. Kalipada Pahan at Rush UniversityMedical Center.
13. DARPA Awards $25 Million To Develop Messenger RNA Therapeutics™
Moderna Therapeutics, which has created a new treatment modality to enable the in vivo production of therapeutic proteins, announced on October 2, 2013, that the Defense Advanced Research Projects Agency (DARPA) has awarded the company up to $25 million to research and develop its messenger RNA therapeutics™ platform as a rapid and reliable way to make antibody-producing drugs to protect against a wide range of known and unknown emerging infectious diseases and engineered biological threats.
Messenger RNA therapeutics™ can be designed to tap directly into the body’s natural processes to produce antibodies without exposing people to a weakened or inactivated virus or pathogen, as is the case with the vaccine approaches currently being tested. As a result, Moderna’s messenger RNA therapeutics™ platform has the potential to speed the development and manufacture of treatments that can produce a safer, more reliable and more robust immune response than existing technologies.
The $24.6 million grant could support research for up to 5 years to advance promising antibody-producing drug candidates into preclinical testing and human clinical trials. The company also received a $700,000 “seedling” grant from DARPA in March to begin work on the project.
This grant is part of a DARPA program called ADEPT: PROTECT (Autonomous Diagnostics to Enable Prevention and Therapeutics: Prophylactic Options to Environmental and Contagious). The goal is to develop platform technologies that can be deployed safely and rapidly to provide the U.S. population with near-immediate protection against emerging infectious diseases and engineered biological weapons, even in cases when the pathogen or infectious agent is unknown.
14. Actavis Files ANDA for Generic Suboxone® Sublingual Film
Actavis plc (NYSE: ACT) confirmed on October 8, 2013, that it filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Film 2 mg/0.5 mg and 8 mg/2 mg. Actavis’ ANDA product is a generic version of Reckitt Benckiser’s Suboxone® Sublingual Film, which is indicated for maintenance treatment of opioid dependence.
Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals Limited and MonoSol Rx, LLC filed suit against Actavis on October 8, 2013, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration certain of U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities. For a basic tutorial on Hatch-Waxman see A Primer on Paragraph IV Certifications and Supreme Say Reverse Payments May Be Antitrust Violation.
Actavis says that it believes it is the first applicant to file an ANDA for a generic version of Suboxone® Film and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending August 31, 2013, Suboxone® Film 2/0.5mg and 8/2 mg had total U.S. sales of approximately $1.2 billion, according to IMS Health data.
15. AzaSite® Patents Upheld in Patent Infringement Lawsuit Against Sandoz
InSite Vision Incorporated (OTCBB: INSV) announced on October 7, 2013, that the United States District Court for the District of New Jersey upheld all four of the patents protecting AzaSite® (azithromycin 1% ophthalmic solution) in a patent infringement lawsuit against Sandoz Inc.
Sandoz filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) in 2011 seeking to market a generic version of AzaSite before expiration of the patents covering AzaSite and its use. AzaSite is marketed by Merck (NYSE: MRK) in the U.S.
In June 2013 a similar patent infringement lawsuit was filed against Mylan Pharmaceuticals. A trial date in this matter has not been set.
Mylan filed an ANDA application for AzaSite with the FDA of which InSite received notice on May 2, 2013, and InSite had 45 days to file a patent infringement lawsuit. This lawsuit triggered an automatic stay, or bar, of the FDA’s approval of the ANDA for up to 30 months or until a final court decision of the infringement lawsuit, whichever comes first.
InSite owns its U.S. patents covering AzaSite and its use, and an exclusive license to a Pfizer-owned azithromycin patent.
16. Innovative Cancer Treatment Wins Global Design Competition
ChemoPatch™, a low-cost, disposable, electronic patch-based cancer chemotherapy device designed to be simple, automated, and easy-to-use by cancer patients outside of the hospital, has been awarded the grand prize of $20,000 in the 2013 “Create the Future” Design Contest.
The ChemoPatch, is a patent-pending device that is able to administer up to three different chemotherapy drugs in select doses and at specific time intervals. Drug delivery is automated, allowing patients to reduce the frequency of hospital visits. The device is undergoing CE mark approval processes in the UK and will start clinical trials in India.
ChemoPatch was among the more than 925 new product ideas submitted in the 11th annual design contest, which was established in 2002 to recognize and reward engineering innovations that benefit humanity, the environment, and the economy.
17. Teva Gets Favorable Ruling on COPAXONE in the Netherlands
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced that the District Court of the Hague (Netherlands) has issued a favorable ruling in a patent revocation action brought by Mylan B.V., a subsidiary of Mylan Laboratories Inc., seeking a court judgment that Teva’s European Patent (NL) 762,888 expiring May 2015 for its relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE® (glatiramer acetate injection) is invalid. The District Court of the Hague rejected each one of the grounds of invalidity Mylan had raised against the claims of Teva’s ‘888 patent. The favorable ruling follows a similar outcome in the English Court of Appeal in July 2013 which also affirmed that the claims of Teva’s patent are valid.
Any potential generic version of COPAXONE® would require a marketing authorization from the Netherlands Medicines Evaluation Board (MEB) before it could be commercialized. Given the complexity of COPAXONE®, Teva believes unpredictable differences between a proposed generic product and COPAXONE® could lead to immunogenic effects in patients. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of COPAXONE® would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in RRMS patients.
18. BVGH Recruits Dr. Linda Venczel as New Program Director
BIO Ventures for Global Health (BVGH) announced on October 2, 2013, that Dr. Linda Veronica Venczel has been appointed BVGH’s new Director of Program and Partnership Management. Most recently Dr. Venczel was Senior Program Officer, Global Development at the Bill & Melinda Gates Foundation, Deputy Branch Chief for Polio Eradication at the Centers for Disease Control and Prevention in Atlanta, and International Advisor on Vaccines and Immunization for Bolivia at the Pan American Health Organization in Washington DC.
“The addition of Linda to the BVGH team will have an important impact in further developing BVGH’s strategy, managing and developing new research programs and assisting with grants and fundraising. Linda brings a new breadth and level of global health experience that will further BVGH’s progress,” said Jennifer Dent, who is President of BVGH.
BVGH was formed by the Biotechnology Industry Organization (BIO) with funding from the Bill & Melinda Gates Foundation and works with the WIPO, a United Nations agency. BVGH identifies partnership opportunities and facilitates the sharing of vital assets and information between private industry companies and researchers in the US and overseas to develop new therapies for unmet medical needs.
19. Actavis’s settles with FTC over $8.5 Billion acquisition of Warner Chilcott
Although not in October, since the last edition of Pharma & Biotech News, at the end of September Actavis, Inc. agreed to sell all rights and assets to four generic pharmaceuticals – three oral contraceptives and an osteoporosis treatment – to settle FTC charges that its proposed $8.5 billion acquisition of drug-maker Warner Chilcott plc would be anticompetitive. As part of the proposed settlement, Actavis is seeking FTC approval to sell the rights and assets for each drug to New Jersey-based Amneal Pharmaceuticals L.L.C. The FTC’s proposed order is designed to preserve competition in each of the following pharmaceutical markets:
- Generic Femcon FE, a chewable oral contraceptive tablet that contains progestin and estrogen;
- Loestrin 24 FE and its generic equivalents, which are low-dose progestin/estrogen combination oral contraceptives;
- Lo Loestrin FE and its generic equivalents, which are also progestin/estrogen combination oral contraceptives; and
- Atelvia and its generic equivalents, which are delayed-release tablets used to treat post-menopausal osteoporosis.
According to the FTC’s complaint, Actavis and Warner Chilcott are the only two significant manufacturers of generic Femcon FE, and the proposed acquisition would eliminate current competition between them in the market for this drug.
The proposed consent order requires Actavis to sell to Amneal all of Actavis’s rights and assets related to its generic versions of Femcon FE, Loestrin 24 FE, Lo Loestrin FE, and Atelvia. It also requires Actavis to enter into an agreement to supply generic versions of Femcon FE and Loestrin 24 FE to Amneal for two years, after which Amneal may extend the agreement for two more years. With 65 other generic products already on the market, the FTC believes Amneal has the expertise to replicate the competition for the four drugs that otherwise would have been lost through the proposed acquisition. Finally, the proposed order requires Actavis to relinquish its claim to first filer marketing exclusivity for generic Lo Loestrin FE and Atelvia products to preserve the incentives of the companies currently leading the patent litigations against Warner Chilcott related to those products.