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26 Dec 2014

Claris Lifesciences confirms patent challenge for its generic version of PROPOFOL in USA

Claris Lifesciences has filed an Abbreviated New Drug Application (ANDA) for Propofol for Injection, 10 mg/ml with the US Food and Drug Administration (USFDA) with a Paragraph IV certification. The company’s ANDA is a generic version of DIPRIVAN, which is indicated for general anaesthesia for surgery or other medical procedures. According to the IMS health data as on June 2014, Propofol Injection had an annual market size of approximately $251 million in the USA.

Originator Information: 

Active Ingredient: PROPOFOL
Dosage Form;Route: INJECTABLE;INJECTION
Proprietary Name: DIPRIVAN
Applicant: FRESENIUS KABI USA
Strength: 10MG/ML
Application Number: N019627
Product Number: 002
Approval Date: Jun 11, 1996
Reference Listed Drug Yes
RX/OTC/DISCN: RX

Claris Lifesciences is one of the few injectables companies in India to have its own front end in the US, the company markets its products through its wholly owned subsidiary Claris Lifesciences Inc. The company now has 11 ANDAs approved and has a total filing of 32 ANDAs.Fresenius Kabi USA, Inc. has filed a suit against the company on December 19, 2014, in the United States District Court, District of Delaware, seeking to prevent the company from commercializing its ANDA prior to the expiration of its existing patent, on December 01, 2024. The company has received satisfactory opinions from consultants and legal advisors that the claims of the patent will not be infringed by the company’s product. If the company wins, then it will be able to launch the product significantly prior to the expiry of the patent.

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