Community Pharmacy Network

Perrigo files ANDA for generic Astepro Nasal Spray

Perrigo announced that it filed an ANDA with the FDA for azelastine hydrochloride nasal spray (0.15%), a generic version of Meda's Astepro. On January 19, 2012, Meda filed suit against Perrigo, alleging patent infringement and formally initiating the process under the Hatch-Waxman Act. Annual sales of Astepro were approximately $114 million annually, as measured by Wolters Kluwer Health.

Watson and Mallinckrodt settle over generic Exalgo

Watson and Mallinckrodt have reached a settlement concerning Exalgo, for which Watson had sought FDA approval. Mallinckrodt filed a patent-infringement suit against Watson in December 2010 after Watson applied for FDA approval for a generic version of the drug in the 8mg, 12mg and 1-mg strengths. Under the settlement, Watson receives a royalty-free license to patents related to Exalgo and can launch a generic version in November 2013. Other terms of the settlement were not disclosed. Watson stated it was probably the first company to seek approval for a generic version, which would entitle it to 180 days of market exclusivity.

Lupin receives tentative FDA approval for generic Glumetza ER

Lupin announced it received tentative FDA approval for its metformin hydrochloride extended release tablets, the AB-rated generic version of Santarus' Glumetza ER. The brand had annual U.S. sales of approximately $58 million, for the twelve months ending September 2011, according to IMS Health Data. Lupin believes it is the first applicant to file an ANDA for a generic version of Glumetza ER and will be entitled to 180 days of marketing exclusivity. FDA approves Mylan's generic Doryx

The FDA approved Mylan's doxycycline hyalite delayed-release tablets, a generic version of Warner Chilcott's Doryx. Warner Chilcott launched a patent infringement suit against Mylan in response to the latter's filing for FDA approval of the drug. The court is expected to reach a decision in March, and Mylan stated it agreed not to launch the drug until then, though it expected to be the first to launch a generic version. Doryx had sales of approximately $264.1 million in 2011, according to IMS Health.

Watson and J&J settle lawsuit over generic Ortho Tri-Cyclen Lo

Subsidiaries of Watson and Johnson & Johnson have settled a lawsuit filed by J&J in 2008 when Watson attempted to market a generic version of Ortho Tri-Cyclen Lo (norgestimate and ethinyl estradiol). Janssen filed the suit after Watson sought FDA approval for the drug prior to the expiration of a patent covering it. The patent covering the drug's use in adults is scheduled to expire in June 2019, according to FDA records. Under the settlement, Janssen will manufacture and supply Watson with an authorized generic version of the drug, while Watson will have the right to market and distribute it at the end of 2015. Other terms of the deal were not disclosed.

Watson seeks FDA approval for generic Beyaz

Watson has filed an ANDA with the FDA for its generic version of Bayer's Beyaz oral contraceptive. Bayer and Merck filed a lawsuit against Watson to prevent Watson from launching a generic version of Beyaz prior to the expiration of its patent. Watson stated it believes it may be a "first applicant" to file an ANDA for a generic version of Beyaz and may be entitled to 180 days of market exclusivity, if the application is approved.

Mylan to challenge court decision over generic Xopenex

Mylan plans to challenge a court decision that requires it to pay almost $20 million to Sunovion, whose product it tried to market as a generic. Sunovion sued Mylan when Mylan sought to market a generic version of Sunovion's Xopenex (levalbuterol hydrochloride) inhalation solution. The jury's verdict includes an $18 million award. "While this is not a significant product for Mylan, we firmly believe that the jury has erred and intend to seek reversal through post-trial motions and, if necessary, an appeal of the verdict and the damages award," Mylan CEO Heather Bresch said.