Actavis PLC (NYSE: ACT) recently filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone Topical Solution, 30mg/1.5mL.  Actavis’ ANDA product is a generic version of Eli Lilly and Company’s Axiron^®, which is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

Eli Lilly and Company and Acrux DDS Pty Ltd. filed suit against Actavis on November 12, 2013, in the U.S. District Court for the Southern District of Indiana seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain of its 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.

The patents at issue in this Hatch-Waxman lawsuit, and which cover Axiron® are:

1. U.S. Patent No. US 6,299,900, titled Dermal penetration enhancers and drug delivery systems involving same, and which relates to a transdermal drug delivery system which comprises at least one physiologically active agent or prodrug thereof and at least one dermal penetration enhancer; characterised in that the dermal penetration enhancer is a safe skin-tolerant ester sunscreen.
2. U.S. Patent No. US 6,818,226, titled Dermal penetration enhancers and drug delivery systems involving same, and which relates to a transdermal drug delivery system which comprises at least one physiologically active agent or prodrug thereof and at least one dermal penetration enhancer; characterised in that the dermal penetration enhancer is a safe skin-tolerant ester sunscreen.
3. U.S. Patent No. US 6,923,983, titled Transdermal delivery of hormones, and which relates to a transdermal drug delivery system which comprises: a therapeutically effective amount of a hormone; at least one dermal penetration enhancer, which is a safe skin-tolerant ester sunscreen ester; and at least one volatile liquid.
4. U.S. Patent No. US 8,071,075, titled Dermal penetration enhancers and drug delivery systems involving the same, and which relates to a method for treatment or prophylaxis of a disease or condition in an animal comprising administering to a mucosal membrane of said animal in need of such treatment a therapeutically effective amount of a drug delivery system comprising at least one physiologically active agent or prodrug thereof and at least one penetration enhancer selected from safe ester sunscreens.
5. U.S. Patent No. US 8,419,307, titled Spreading implement, which generally relates to methods comprising applying a liquid pharmaceutical testosterone composition with an implement, which itself is defined in the disclosure.
6. U.S. Patent No. US 8,435,944, titled Method and composition for transdermal drug delivery, which relates to a transdermal drug delivery composition which includes at least one physiologically active agent; and at least one volatile solvent; and at least one viscosity modulating agent. The invention extends to methods of administering such a composition to a subject and treatment of subjects using the composition.

According to Actavis, the company believes that it may be the “first applicant” to file an ANDA for a generic version of Axiron^®. This means that if Actavis’s ANDA is approved, it would be entitled to 180 days of generic market exclusivity.

For the 12 months ending September 30, 2013, Axiron^® had total U.S. sales of approximately $257 million, according to IMS Health data.

Tags: Axiron, Eli Lilly, generic pharmaceuticals, Hatch-Waxman Litigation, patent, patents, pharma

This entry was posted on Monday, November 18th, 2013 at 19:40 and is filed under patent infringement, Patent Issues, posts. You can follow any responses to this entry through the RSS 2.0 feed. You can skip to the end and leave a response. Pinging is currently not allowed.