NAPROXEN - Generic Drug Details
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What are the generic sources for naproxen and what is the scope of freedom to operate?
Naproxen
is the generic ingredient in twelve branded drugs marketed by Atnahs Pharma Us, Amneal, Hetero Labs Ltd Iii, Hikma, Novitium Pharma, Actavis Elizabeth, Aurobindo Pharma Usa, Fosun Pharma, Nuvo Pharms Inc, Pliva, Teva, Trupharma, Adaptis, 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, Norvium Bioscience, Purepac Pharm, Roxane, Sciegen Pharms Inc, Teva Pharms, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, Twi Pharms, Actavis Labs Fl Inc, Bayer, Able, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Granules India, Hetero Labs Ltd V, Lnk Intl Inc, Marksans Pharma, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Sandoz, Sun Pharm Inds Ltd, Yichang Humanwell, Rising, Sun Pharm, and Currax, and is included in ninety NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are forty-two drug master file entries for naproxen. Fifty-eight suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for NAPROXEN
US Patents: | 6 |
Tradenames: | 12 |
Applicants: | 58 |
NDAs: | 90 |
Drug Master File Entries: | 42 |
Finished Product Suppliers / Packagers: | 58 |
Raw Ingredient (Bulk) Api Vendors: | 135 |
Clinical Trials: | 323 |
Patent Applications: | 3,391 |
Drug Prices: | Drug price trends 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 |
Generic filers with tentative approvals for NAPROXEN
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 500MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 375MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 250MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Contract Pharmacal | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074635-001 | Jan 13, 1997 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Roxane | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074257-001 | Dec 21, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sun Pharm | SUMATRIPTAN AND NAPROXEN SODIUM | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 202803-001 | Jul 20, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma Usa | NAPROXEN | naproxen | TABLET, DELAYED RELEASE;ORAL | 075390-001 | Apr 19, 2001 | DISCN | 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 |
Expired US Patents for NAPROXEN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-004 | Apr 15, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-004 | Apr 15, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-003 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Atnahs Pharma Us | NAPROSYN | naproxen | SUSPENSION;ORAL | 018965-001 | Mar 23, 1987 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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