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Naproxen sodium - Generic Drug Details
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What are the generic drug sources for naproxen sodium and what is the scope of freedom to operate?
Naproxen sodium
is the generic ingredient in nine branded drugs marketed by Bionpharma Inc, Catalent, Puracap Pharm Llc, Almatica, Actavis Labs Fl Inc, Bayer, Atnahs Pharma Us, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Hamilton Pharms, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Mylan, 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, Sun Pharm, and Currax, and is included in forty-seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Naproxen sodium has fifteen patent family members in thirteen countries.
There are forty-two drug master file entries for naproxen sodium. One hundred and twenty-one suppliers are listed for this compound.
Summary for naproxen sodium
International Patents: | 15 |
US Patents: | 5 |
Tradenames: | 9 |
Applicants: | 36 |
NDAs: | 47 |
Drug Master File Entries: | 42 |
Suppliers / Packagers: | 121 |
Bulk Api Vendors: | 84 |
Clinical Trials: | 87 |
Patent Applications: | 7,185 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
Recent Clinical Trials for naproxen sodium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Pennsylvania | Phase 4 |
Hersh, Elliot V., DMD, MS, PhD | Phase 4 |
Ege University | N/A |
Pharmacology for naproxen sodium
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Paragraph IV (Patent) Challenges for NAPROXEN SODIUM
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
NAPROXEN SODIUM | CAPSULE;ORAL | naproxen sodium | 021920 | 2017-11-15 |
NAPRELAN | TABLET, EXTENDED RELEASE;ORAL | naproxen sodium | 020353 |
US Patents and Regulatory Information for naproxen sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074142-001 | Dec 21, 1993 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Contract Pharmacal | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074635-001 | Jan 13, 1997 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
Sandoz | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074495-001 | Dec 5, 1994 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Teva | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074142-002 | Dec 21, 1993 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Mylan | SUMATRIPTAN AND NAPROXEN SODIUM | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 090872-001 | Sep 4, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Actavis Labs Fl Inc | NAPROXEN SODIUM | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 075416-003 | Aug 11, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Able | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 076544-001 | Aug 22, 2003 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
>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 sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Atnahs Pharma Us | ANAPROX DS | naproxen sodium | TABLET;ORAL | 018164-003 | Sep 30, 1987 | Start Trial | Start Trial |
Almatica | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-001 | Jan 5, 1996 | Start Trial | Start Trial |
Atnahs Pharma Us | ANAPROX | naproxen sodium | TABLET;ORAL | 018164-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Atnahs Pharma Us | ANAPROX | naproxen sodium | TABLET;ORAL | 018164-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Almatica | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-002 | Jan 5, 1996 | Start Trial | Start Trial |
Atnahs Pharma Us | ANAPROX DS | naproxen sodium | TABLET;ORAL | 018164-003 | Sep 30, 1987 | Start Trial | Start Trial |
Almatica | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-003 | Jan 5, 1996 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for naproxen sodium
Country | Patent Number | Estimated Expiration |
---|---|---|
Lithuania | 1863458 | Start Trial |
Slovenia | 1863458 | Start Trial |
Canada | 2600023 | Start Trial |
European Patent Office | 1863458 | Start Trial |
World Intellectual Property Organization (WIPO) | 2006096580 | Start Trial |
Hungary | E030784 | Start Trial |
China | 102940887 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for naproxen sodium
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0984957 | PA2011005 | Lithuania | Start Trial | PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126 |
1411900 | 2011/016 | Ireland | Start Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105 |
0984957 | CR 2012 00035 | Denmark | Start Trial | 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 |
1411900 | SPC/GB11/015 | United Kingdom | Start Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
0984957 | PA2011005,C0984957 | Lithuania | Start Trial | PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126 |
0984957 | 122012000051 | Germany | Start Trial | PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105 |
0984957 | SPC/GB11/013 | United Kingdom | Start Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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