naproxen sodium Drug Patent Profile
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When do Naproxen Sodium patents expire, and what generic alternatives are available?
Naproxen Sodium is a drug marketed by Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, Actavis Labs Fl Inc, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Hamilton Pharms, Hetero Labs Ltd V, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Norvium Bioscience, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Pliva, Purepac Pharm, Roxane, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva, Teva Pharms, Watson Labs, Yichang Humanwell, Amneal Pharms Co, Corepharma, Granules, P And L, Perrigo R And D, and Aurobindo Pharma. and is included in forty-eight NDAs. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has fifteen patent family members in thirteen countries.
The generic ingredient in NAPROXEN SODIUM 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 Sodium
A generic version of naproxen sodium was approved as naproxen sodium; pseudoephedrine hydrochloride by PERRIGO on March 17th, 2004.
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Summary for naproxen sodium
| International Patents: | 15 |
| US Patents: | 5 |
| Applicants: | 40 |
| NDAs: | 48 |
| Finished Product Suppliers / Packagers: | 123 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Clinical Trials: | 100 |
| Patent Applications: | 6,228 |
| Drug Prices: | Drug price information for naproxen sodium |
| Drug Sales Revenues: | Drug sales revenues for naproxen sodium |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for naproxen sodium |
| What excipients (inactive ingredients) are in naproxen sodium? | naproxen sodium excipients list |
| DailyMed Link: | naproxen sodium at DailyMed |
See drug prices for naproxen sodium
Recent Clinical Trials for naproxen sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Johnson & Johnson Consumer Inc. (J&JCI) | Phase 1 |
| Johnson & Johnson Consumer Inc. (J&JCI) | Phase 3 |
| Ciusss de L'Est de l'Île de Montréal | N/A |
Pharmacology for naproxen sodium
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for naproxen sodium
Paragraph IV (Patent) Challenges for NAPROXEN SODIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NAPROXEN SODIUM | Capsules | naproxen sodium | 200 mg | 021920 | 1 | 2017-11-15 |
US Patents and Regulatory Information for naproxen sodium
naproxen sodium is protected by eight US patents.
Patents protecting naproxen sodium
Liquid dosage forms of sodium naproxen
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Patented Use: TEMPORARY RELIEF OF MINOR ACHES AND PAINS
Liquid dosage forms of sodium naproxen
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Patented Use: TEMPORARY REDUCTION OF FEVER
Liquid dosage forms of sodium naproxen
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Patented Use: TEMPORARY RELIEF OF MINOR ACHES AND PAINS
Liquid dosage forms of sodium naproxen
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Patent Expiration: ⤷ Sign Up
Patented Use: TEMPORARY REDUCTION OF FEVER
Liquid dosage forms of sodium naproxen
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Patent Expiration: ⤷ Sign Up
Patented Use: TEMPORARY RELIEF OF MINOR ACHES AND PAINS
Liquid dosage forms of sodium naproxen
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Patent Expiration: ⤷ Sign Up
Patented Use: TEMPORARY REDUCTION OF FEVER
Solvent system for enhancing the solubility of pharmaceutical agents
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Liquid dosage forms of sodium naproxen
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Granules | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride; naproxen sodium | TABLET;ORAL | 213663-001 | Sep 24, 2020 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074367-001 | Aug 31, 1994 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hamilton Pharms | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074106-001 | Aug 31, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Purepac Pharm | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074319-002 | Mar 20, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074198-001 | Dec 21, 1993 | 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 |
International Patents for naproxen sodium
See the table below for patents covering naproxen sodium around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 102940887 | Solvent system for enhancing the solubility of pharmaceutical agents | ⤷ Sign Up |
| Slovenia | 1863458 | ⤷ Sign Up | |
| China | 101166520 | Solvent system for enhancing the solubility of pharmaceutical agents | ⤷ Sign Up |
| Lithuania | 1863458 | ⤷ Sign Up | |
| Hungary | E030784 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for naproxen sodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1411900 | SPC/GB11/015 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 1411900 | 1190013-1 | Sweden | ⤷ Sign Up | PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105 |
| 0984957 | CR 2012 00035 | Denmark | ⤷ Sign Up | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105 |
| 0984957 | PA2011005,C0984957 | Lithuania | ⤷ Sign Up | PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126 |
| 1411900 | C300481 | Netherlands | ⤷ Sign Up | PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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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