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-seven 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: | 57 |
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 |
⤷ Subscribe | ⤷ Subscribe | 500MG | TABLET;ORAL |
⤷ Subscribe | ⤷ Subscribe | 375MG | TABLET;ORAL |
⤷ Subscribe | ⤷ Subscribe | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma Ltd | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 205497-001 | Mar 18, 2016 | OTC | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Watson Labs | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074455-002 | May 31, 1995 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Novitium Pharma | NAPROXEN | naproxen | TABLET, DELAYED RELEASE;ORAL | 218497-002 | Jun 12, 2024 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Hikma | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074480-002 | Feb 18, 1998 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Watson Labs | NAPROXEN | naproxen | TABLET;ORAL | 074457-002 | May 31, 1995 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Purepac Pharm | NAPROXEN | naproxen | TABLET;ORAL | 074263-003 | Dec 21, 1993 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Norvium Bioscience | NAPROXEN | naproxen | TABLET;ORAL | 074121-003 | Dec 21, 1993 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | 017581-003 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-004 | Apr 15, 1982 | ⤷ Subscribe | ⤷ Subscribe |
Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-002 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-003 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
Atnahs Pharma Us | NAPROSYN | naproxen | SUSPENSION;ORAL | 018965-001 | Mar 23, 1987 | ⤷ Subscribe | ⤷ Subscribe |
Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-004 | Apr 15, 1982 | ⤷ Subscribe | ⤷ Subscribe |
Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-002 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
NAPROXEN Market Analysis and Financial Projection Experimental
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