PHARMACY

Patents covering Sanctura XR invalid, court rules

BY Alaric DeArment

PARSIPPANY, N.J. — A court has ruled that patents covering a drug designed to treat an overactive bladder are invalid, a company looking to launch a generic version of the drug said.

Watson Pharmaceuticals said the U.S. District Court for the District of Delaware ruled that five patents covering Allergan’s Sanctura XR (trospium chloride) extended-release capsules were invalid. Watson’s application with the Food and Drug Administration for a generic version are pending, the company said.

Sanctura XR had sales of $68 million during the 12-month period ended in February, according to IMS Health.


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PHARMACY

Amylin seeks FDA approval for metreleptin

BY Alaric DeArment

SAN DIEGO — Drug maker Amylin Pharmaceuticals has filed for regulatory approval of a drug to treat diabetes and elevated triglycerides in the bloodstream in children and adults with a rare disorder.

Amylin announced the submission of an application to the Food and Drug Administration for metreleptin in patients with rare forms of lipodystrophy, a life-threatening disorder estimated to affect only a few thousand people around the world. The disease results from the body’s inability to create the hormone leptin, resulting in fat buildup in the blood and organs like the liver and muscles, causing such life-threatening complications as insulin-resistant diabetes, high triglycerides in the blood — also known as hypertriglyceridemia — acute pancreatitis and others.

"Completion of this submission is an important milestone for Amylin and for patients with rare forms of lipodystrophy who currently have limited and often insufficient treatment options for this under-recognized and life-threatening disease," Amylin president and CEO Daniel Bradbury said. "Metreleptin is an integral component of our ongoing commitment to improve the lives of patients with metabolic diseases, from the rarest to the most prevalent."

 


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Watson seeks approval for generic Lumigan, Latisse

BY Alaric DeArment

PARSIPPANY, N.J. — Watson is challenging the patent protection on two eye drugs made by Allergan, the generic drug maker said Tuesday.

Watson announced that it had filed with the Food and Drug Administration for generic versions of Allergan’s Lumigan and Latisse (bimatoprost) ophthalmic solution. The products contain the same active ingredient in the 0.01% and 0.03% strengths, respectively, and are used to reduce pressure within the eye in patients with open-angle glaucoma or ocular hypertension.

In response to Watson’s filings, Allergan filed suit against the company in the U.S. District Court for the Eastern District of Texas on March 23 to prevent Watson from launching a generic version of Lumigan. In addition, Allergan and Duke University sued Watson in the U.S. District Court for the Middle District of North Carolina on Saturday to prevent the launch of Latisse.

The lawsuits put a stay of final FDA approval on Watson’s products for 30 months or until the companies reach a settlement.

Lumigan and Latisse had respective sales of $409 million and $80 million during the 12-month period ended in January, according to IMS Health.

 


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S.SWAREZ says:
Apr-04-2012 12:16 pm

I think this would be great news for the Cost of Latisse. Currently the price point is down to $79 from latisse.bz Further price reductions would allow the benefits to reach the greater population.

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