NAPROXEN Drug Patent Profile
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When do Naproxen patents expire, and what generic alternatives are available?
Naproxen is a drug marketed by Amneal, Hetero Labs Ltd Iii, Hikma, Novitium Pharma, Actavis Elizabeth, Aurobindo Pharma Usa, Fosun Pharma, Nuvo Pharms Inc, Pliva, Teva, Tulex Pharms Inc, Amneal Pharms Ny, Aurobindo Pharma, Chartwell Molecules, Dava Pharms Inc, Glenmark Generics, Granules, Hamilton Pharms, Hikma Intl Pharms, Invagen Pharms, Ivax Sub Teva Pharms, L Perrigo Co, Marksans Pharma, Mylan, Purepac Pharm, Roxane, Sciegen Pharms Inc, Teva Pharms, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Dr Reddys, Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, Able, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Hetero Labs Ltd V, Lnk Intl Inc, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Sandoz, Sun Pharm Inds Ltd, Yichang Humanwell, Amneal Pharms Co, Corepharma, P And L, and Perrigo R And D. and is included in eighty-eight NDAs. There are five patents protecting this drug.
The generic ingredient in NAPROXEN is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Naproxen
A generic version of NAPROXEN was approved as naproxen sodium; pseudoephedrine hydrochloride by PERRIGO on March 17th, 2004.
Summary for NAPROXEN
US Patents: | 0 |
Applicants: | 58 |
NDAs: | 88 |
Finished Product Suppliers / Packagers: | 53 |
Raw Ingredient (Bulk) Api Vendors: | 135 |
Clinical Trials: | 323 |
Patent Applications: | 4,655 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for NAPROXEN |
Drug Sales Revenues: | Drug sales revenues for NAPROXEN |
What excipients (inactive ingredients) are in NAPROXEN? | NAPROXEN excipients list |
DailyMed Link: | NAPROXEN at DailyMed |
Recent Clinical Trials for NAPROXEN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mclean Hospital | Phase 4 |
United States Department of Defense | Phase 4 |
Johnson & Johnson Consumer Inc. (J&JCI) | Phase 1 |
Pharmacology for NAPROXEN
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for NAPROXEN
Anatomical Therapeutic Chemical (ATC) Classes for NAPROXEN
US Patents and Regulatory Information for NAPROXEN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva | NAPROXEN | naproxen | TABLET;ORAL | 074216-001 | Apr 11, 1996 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bionpharma | NAPROXEN SODIUM | naproxen sodium | CAPSULE;ORAL | 021920-001 | Feb 17, 2006 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Hikma Intl Pharms | NAPROXEN | naproxen | TABLET;ORAL | 076494-002 | Jan 14, 2004 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Glenmark Generics | NAPROXEN | naproxen | TABLET;ORAL | 078250-002 | Mar 28, 2007 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Watson Labs | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074455-002 | May 31, 1995 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |