Meda Pharmaceuticals Inc and Cipla have sued Apotex Inc and Apotex Corporation (Apotex) in Federal District Court in Delaware to enforce the Orange-Book listed patents covering Dymista (azelastine HCl/fluticasone propionate) Nasal Spray in response to Apotex's submission to the US Food and Drug Administration (FDA) of an Abbreviated New Drug Application (ANDA), and accompanying Paragraph IV certification, seeking approval to market a generic version of Meda’s Dymista prior to expiration of the Dymista patents.
The Complaint was filed within 45 days of receiving Apotex’s Paragraph IV certification notice, thus triggering an automatic stay preventing the FDA from approving Apotex’s ANDA for 30 months from receipt of the notice, unless ordered otherwise by a district court. Meda has the exclusive licenses to U.S. Patent Nos. 8,163,723 and 8,168,620 covering the Dymista composition and its approved uses, which does not expire until 2026. Meda holds the New Drug Application (NDA) to manufacture and market Dymista in the US for the treatment of seasonal allergic rhinitis.
Meda and Cipla are jointly represented by attorneys from Sterne, Kessler, Goldstein & Fox P.L.L.C. and Ashby & Geddes, PA.
Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 170 countries. Its portfolio includes 2000 products in 65 therapeutic categories with one quality standard globally.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1669.45 |
| Dr. Reddys Lab | 1237.15 |
| Cipla | 1237.30 |
| Zydus Lifesciences | 943.05 |
| Lupin | 2332.80 |
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