Breckenridge Announces Approval of Rizatriptan Benzoate ODT (Orally Disintegrating Tablets)

Jul 03, 2013, 10:31 ET from Breckenridge Pharmaceutical, Inc.

BOCA RATON, Fla., July 3, 2013 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces the immediate launch of Rizatriptan Benzoate Orally Disintegrating Tablets.  The U.S. Food and Drug Administration granted final approval for the Abbreviated New Drug Application (ANDA) for this product on July 1, 2013, approximately nine (9) months prior to expiration of the pediatric-exclusivity period for the challenged Orange Book patent (April 1, 2014).  Breckenridge's ANDA to Maxalt-MLT® contained a Paragraph IV certification patent challenge, permitting launch after the 180-day exclusivity period of the first filer. 

Breckenridge's Rizatriptan Benzoate ODT is manufactured and supplied by Natco Pharma Limited, the ANDA holder, and will be supplied in both 5mg and 10mg strengths.  Rizatriptan Benzoate Orally Disintegrating Tablets are AB rated to Maxalt-MLT®, a $200 million dollar brand drug marketed by Merck & Co., Inc.  Maxalt-MLT® is a prescription medicine indicated for the acute treatment of migraines.  Breckenridge and Natco also launched Rizatriptan Benzoate Tablets on December 31, 2012. 

Breckenridge's patent challenge regarding Rizatriptan Benzoate Orally Disintegrating Tablets is a continuing part of its larger aggressive Paragraph IV strategy commenced a few years ago.   Since the beginning of 2011, Breckenridge has filed twelve (12) Paragraph IV patent challenges and intends to continue that trend in the next several years, focusing on niche Paragraph IV opportunities with certain barriers to entry.

About Breckenridge:

Breckenridge is a privately-held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of generic prescription products and Medical Foods in many therapeutic categories. The Breckenridge label is recognized by Wholesalers, Distributors, Chains, and Managed Care Accounts, as well as Retail Pharmacies nationwide. The company markets over 60 products in a variety of dosage forms including: Tablets, Capsules, Soft Gel Capsules, and Liquids, and Powders.

SOURCE Breckenridge Pharmaceutical, Inc.