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Endo International Plc staved off generic competition to Aveed, its injectable long-acting testosterone replacement therapy, until 2027 ( Endo Pharm. Solutions, Inc. v. Custopharm, Inc. , 2017 BL 41185, D. Del., No. 14-1422-SLR, 2/10/17 ).
Custopharm Inc., which filed an abbreviated new drug application (ANDA) seeking FDA approval to make a generic version of Aveed, didn’t prove the patents on Aveed were invalid, Judge Sue L. Robinson of the U.S. District Court for the District of Delaware ruled Feb. 10.
The ruling means Aveed (testosterone undecanoate) won’t face generic competition until March 14, 2027, when the second of the challenged patents at issue in the litigation expires.
Both of the patents, U.S. Patent Nos. 7,718,640 and 8,338,395, cover methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels. Custopharm failed to clearly and convincingly prove the patent claims were obvious, Robinson said.
The automatic 30-month stay on FDA final approval of Custopharm’s proposed generic expires April 9 but the adverse decision all but guarantees there won’t be any final FDA approval of Custopharm’s generic anytime soon.
“We are very pleased with Judge Robinson’s ruling for Endo recognizing and upholding the validity of the patents at issue,” Endo Executive Vice President and Chief Legal Officer Matthew J. Maletta told Bloomberg BNA Feb. 13. “As a result of the ruling, we believe generic competitors to Aveed must remain off the market until patent expiration in 2027.”
Custopharm wasn’t providing comment on the ruling at this time, a company representative told Bloomberg BNA Feb. 13.
Aveed brings in about $11 million a year in U.S. revenues, according to Bloomberg Intelligence analyst Elizabeth Krutoholow. Bayer Healthcare Pharmaceuticals manufactures the drug and has licensed the rights to Endo, Krutoholow told Bloomberg BNA Feb. 13.
Aveed competes with several other testosterone replacement products on the market, including AbbVie’s AndroGel and Eli Lilly’s Axiron, Krutoholow said. Unlike some other testosterone products that are patches or gels, Aveed is implanted under the skin. It’s designed to provide replacement testosterone for up to three months before a patient requires another injection.
Endo has new-product exclusivity on Aveed, which is set to expire March 5, according to the Food and Drug Administration’s Orange Book (formally titled “Approved Drug Products with Therapeutic Equivalence Evaluations"). The Orange Book is a listing of patents brand-name manufacturers claim cover their drug products.
Endo also makes another intramuscular injectable testosterone product, Testopel.
Endo’s drug portfolio has centered on pain drugs but Endo is trying to expand beyond its traditional portfolio amid growing public concern about the increasing incidence of painkiller abuse in the U.S. Both Aveed and Testopel are included in Endo’s specialty business, which is part of those expansion efforts, Krutoholow said.
Bartlit Beck Herman Palenchar & Scott LLP in Chicago and Morris, Nichols, Arsht & Tunnell LLP, Wilmington, Del., represented Endo and Bayer. Endo has global headquarters in Dublin and U.S. headquarters in Malvern, Pa. Bayer is based in Germany.
Kelley Drye & Warren LLP in New York and Chicago and Potter Anderson & Corroon LLP, Wilmington, Del., represented Custopharm, a specialty maker of generic injectable products based in Carlsbad, Calif.
Paddock Laboratories LLC and Perrigo Co., the original defendants in the suit, sold the rights to their ANDA to Custopharm in January. Custopharm subsequently replaced Paddock and Perrigo as the defendant in the lawsuit.
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