Generics

JERUSALEM — A possible forthcoming generic from Teva has been cleared of a big hurdle. The U.S. District Court for the District of Delaware ruled Tuesday that the company’s application for approval of a generic of Valeant’s Uceris (budesonide) ER extended-release tablets does not infringe on Valeant’s patent.

PORT WASHINGTON, N.Y. — Generic manufacturer Rising Pharmaceuticals, a subsidiary of Aceto, has launched its latest product. The company recently introduced its generic of Zoloft (sertraline oral solution, 20 mg/ml).

The drug is indicated to treat major depressive disorder, obsessive e-compulsive disorder, panic disorder, post-traumatic stress disorder, social anxiety disorder and premenstrual dysphoric disorder. The product had U.S. sales of $9.94 million for the 12 months ended June 2017, according to QuintilesIMS data.

SILVER SPRING, Md. — Generic manufacturer Lupin has had a busy week. The company has received approval from the Food and Drug Administration for three generics, including generics of Axiron (testosterone topical solution, 30 mg per actuation), Lodosyn (carbidopa) tablets and Kapvay (clonidine hydrochloride) extended-release tablets.

HAYWARD, Calif. — Specialty pharmaceutical company Impax Laboratories has launched its generic of Renvela (sevelamer carbonate) tablets immediately after receiving Food and Drug Administration approval. The drug is indicated to control serum phosphorus in adults and children ages 6 years and older who have chronic kidney disease and are on dialysis.

SILVER SPRING, Md. — The Food and Drug Administration has granted tentative approval to Perrigo for its generic of actinic keratosis treatment Picato Gel (ingenol mebutate, 0.015%). The company said that its submission date made it the first to file for a generic of this product.

SAN DIEGO — Opthalmology-focused company Imprimis Pharmaceuticals will be offering a compounded cyclosporine-based formulation to treat dry eye disease, the company announced Thursday. The products will be packaged in multi-use bottles and include Klarity Drops, a formulation developed by ophthalmologist Dr. Richard Lindstrom.

JERUSALEM — Teva on Wednesday announced the introduction of its generic of Testim (testosterone gel, 1%). The company received approval for the generic from the Food and Drug Administration in September.

Teva’s generic is available as 50 mg in a 5-gm tube. The product is indicated for testosterone replacement therapy in adult males for conditions associated with the deficiency or absence of endogenous testosterone. It carries a boxed warning for secondary exposure to testosterone.

MARSHALL, Texas — Allergan’s recent patent claims on its Restasis eye drops were thrown out Monday with a ruling from the United States District Court for the Eastern District of Texas. The 135-page decision found that Allergan’s patent protection for the drug ended in 2014, and that “Allergan is not entitled to renewed patent rights for Restasis in the form of the second wave of patent protection.”