Zydus Cadila has received final approval from US Food & Drug Administration (USFDA) to market Dimethyl Fumarate Delayed Release Capsules, (US RLD: Tecfidera) in the strengths of 120 mg and 240 mg. In its approval, the USFDA noted that Zydus was one of the first ANDA applicants to submit a substantially complete ANDA and is therefore eligible for 180 days of generic drug exclusivity along with other first ANDA applicants.
The USFDA granted approval following entry of judgment in favor of Zydus Cadila and other ANDA applicants by the United States District Court for the District of Delaware, holding that the only unexpired patent covering Tecfidera is invalid. The group now has 303 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.
Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1854.05 |
| Dr. Reddys Lab | 1313.40 |
| Cipla | 1374.00 |
| Zydus Lifesciences | 941.40 |
| Lupin | 2458.00 |
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