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Generated: July 26, 2017
What are the generic drug sources for naproxen sodium and what is the scope of naproxen sodium freedom to operate?
Naproxen sodium is the generic ingredient in eight branded drugs marketed by Bayer, Hamilton Pharms, Glenmark Pharms Ltd, Actavis Labs Fl Inc, Purepac Pharm, Bionpharma Inc, Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Amneal Pharms Ny, Contract Pharmacal, Pliva, Teva, Able, Marksans Pharma, Sandoz, Alvogen Malta, Granules India, Watson Labs, Roxane, Perrigo, Atnahs Pharma Us, Mylan, Dr Reddys Labs Inc, Lnk Intl Inc, Hikma, Sun Pharm Inds Ltd, Dr Reddys Labs Ltd, Teva Pharms, and Pernix Ireland Ltd, and is included in thirty-nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 8 |
| Patents: | 6 |
| Applicants: | 29 |
| NDAs: | 39 |
| Drug Master File Entries: see list | 42 |
| Suppliers / Packagers: see list | 162 |
| Bulk Api Vendors: see list | 52 |
| Clinical Trials: see list | 2,531 |
| Patent Applications: see list | 6,919 |
| Therapeutic Class: | Anti-inflammatory Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | naproxen sodium at DailyMed |
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer | ALEVE-D SINUS & COLD | naproxen sodium; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021076-001 | Nov 29, 1999 | OTC | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Teva Pharms | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074289-001 | Jan 27, 1994 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sandoz | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074646-001 | Jan 13, 1997 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Amneal Pharms Ny | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 079096-001 | Dec 16, 2008 | OTC | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Granules India | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 091353-001 | Sep 20, 2011 | OTC | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Atnahs Pharma Us | ANAPROX | naproxen sodium | TABLET;ORAL | 018164-001 | Approved Prior to Jan 1, 1982 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Alvogen Malta | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-001 | Jan 5, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Alvogen Malta | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-003 | Jan 5, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Atnahs Pharma Us | ANAPROX DS | naproxen sodium | TABLET;ORAL | 018164-003 | Sep 30, 1987 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Atnahs Pharma Us | ANAPROX | naproxen sodium | TABLET;ORAL | 018164-001 | Approved Prior to Jan 1, 1982 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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