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news.Breckenridge Pharmaceutical, Inc. has announced that it has filed an ANDA with a Paragraph IV certification for Everolimus oral tablets, 0.25 mg, 0.5 mg, and 0.75 mg, a generic version of Zortress by Novartis.
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On August 13, 2014, Novartis AG filed a lawsuit against Breckenridge in the United States District Court for the District of Delaware. Breckenridge submitted its Paragraph IV ANDA on the First-to-File date and expects to be the only generic that is entitled to the 180-day exclusivity period.
Breckenridge’s development partner, Natco Pharma Limited, will commercially manufacture this ANDA exclusively for Breckenridge.
Zortress is a prescription drug that is indicated for the prophylaxis of organ rejection in adult patients, specifically for use in kidney and liver transplants. Zortress generated sales of $43.5 million for the twelve-month period ending July 2014, based on industry sales data.
Breckenridge’s latest patent challenge regarding Everolimus is a continuing part of its larger aggressive Paragraph IV strategy. Since 2011, Breckenridge has had at least eighteen (18) Paragraph IV patent challenges and intends to continue that trend in the next several years, focusing on niche and first-to-file Paragraph IV opportunities with certain barriers to entry.
Breckenridge Pharmaceutical, Inc. is a privately-held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of generic prescription products in many therapeutic categories. The Breckenridge label is recognized by Wholesalers, Distributors, Chains, and Managed Care Accounts, as well as Retail Pharmacies nationwide.