BOCA RATON, Fla., Oct. 12, 2012 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that it has entered into an agreement with Marksans Pharma, Ltd to market its Abbreviated New Drug Application (ANDA) for Gabapentin Capsules, the generic version of Neurontin® Tablets by Pfizer. The product was approved by the U.S. Food and Drug Administration (FDA) on July 21, 2011. Under the terms of this agreement, Marksans Pharma will manufacture and supply the product to Breckenridge Pharmaceutical, Inc., who will have exclusive marketing and distribution rights in the U.S. The companies will start shipping immediately.
Gabapentin Capsules are indicated for the management of postherpetic neuralgia in adults and as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patient's age 3-12 years.
The current generic market is approximately $166M, based on industry sales data. The product is available in 3 strengths: 100mg, 300mg, and 400mg.
About Breckenridge Pharmaceutical, Inc.
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.
About Marksans Pharma:
Marksans Pharma Ltd is a public limited company engaged in research, manufacturing and marketing of wide range of generic products from India. Its manufacturing facility at Goa is approved by USFDA, UK MHRA and Australian TGA health authorities.
SOURCE Breckenridge Pharmaceutical, Inc.