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 Pharms Ltd, Granules, Hamilton Pharms, Hikma Intl Pharms, Invagen Pharms, Ivax Sub Teva Pharms, L Perrigo Co, Marksans Pharma, Norvium Bioscience, 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, Mylan, Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, Able, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs 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-nine 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. Ten 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for NAPROXEN?
- What are the global sales for NAPROXEN?
- What is Average Wholesale Price for NAPROXEN?
Summary for NAPROXEN
| US Patents: | 0 |
| Applicants: | 58 |
| NDAs: | 89 |
| Finished Product Suppliers / Packagers: | 54 |
| Raw Ingredient (Bulk) Api Vendors: | 135 |
| Clinical Trials: | 323 |
| Patent Applications: | 2,141 |
| 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 |
|---|---|
| United States Department of Defense | Phase 4 |
| Mclean Hospital | 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 | 074129-001 | Dec 21, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sciegen Pharms Inc | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 217738-001 | Oct 11, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hamilton Pharms | NAPROXEN | naproxen | TABLET;ORAL | 074110-003 | Oct 30, 1992 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dava Pharms Inc | NAPROXEN | naproxen | TABLET;ORAL | 074105-003 | Dec 21, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074455-001 | May 31, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sciegen Pharms Inc | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 212199-001 | Oct 30, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
