Health Care, Law, and Manufacturing

Perrigo ships generic bladder drug into $54M market

May 31, 2013
| By Pete Daly |
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Perrigo partner gets FDA approval for generic scalp-psoriasis treatment
Allegan-based Perrigo manufactures over the counter and generic prescription drugs. Photo via fb.com

Perrigo has won its legal battle to challenge the validity of the patent on the bladder drug Sanctura XR, even as it begins another patent challenge in its efforts to be first to produce a generic version of a topical testosterone solution.

Allegan-based Perrigo (Nasdaq: PRGO) announced this week that it has received final approval for its generic version of Sanctura XR. Perrigo said it had previously prevailed in litigation at both the district and appellate levels and has since begun immediately shipping its generic version.

Sanctura XR is a medication for the treatment of an overactive bladder and has annual sales of approximately $54 million, as measured by Symphony Health Solutions.

Sanctura XR's generic name is trospium, and the patent on it was held by Allergan, a $5.8 billion specialty drug company in Irvine, Calif., which makes Botox, breast implants and the lap-band device used in weight-loss surgery.

Perrigo v. Eli Lilly and Co. 

In an unrelated matter, on May 24, Eli Lilly and Co. in Indianapolis filed a patent infringement lawsuit against Perrigo Israel Pharmaceuticals Ltd. to block it from selling a generic version of Axiron, Lilly’s topical testosterone solution.

That came after Perrigo notified Lilly it was challenging the patent on Axiron, which has not yet expired.

Perrigo subsequently announced May 29 that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for a testosterone topical solution, the generic version of Lilly’s Axiron topical solution.

Axiron is a prescription medicine used to treat adult males who have low or no testosterone.

Axiron's annual sales have been approximately $229 million, as measured by Symphony Health Solutions.

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