Naproxen sodium - Generic Drug Details
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What are the generic sources for naproxen sodium and what is the scope of patent protection?
Naproxen sodium
is the generic ingredient in nine branded drugs marketed by Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, Twi Pharms, 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, Hetero Labs Ltd V, 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, Aurobindo Pharma, Rising, Sun Pharm, and Currax, and is included in fifty-one NDAs. There are six 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 twenty-two drug master file entries for naproxen sodium. One hundred and thirty-five suppliers are listed for this compound.
Summary for naproxen sodium
International Patents: | 15 |
US Patents: | 6 |
Tradenames: | 9 |
Applicants: | 41 |
NDAs: | 51 |
Drug Master File Entries: | 22 |
Finished Product Suppliers / Packagers: | 135 |
Raw Ingredient (Bulk) Api Vendors: | 93 |
Clinical Trials: | 100 |
Patent Applications: | 7,012 |
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 |
---|---|
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 |
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
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Atnahs Pharma Us | ANAPROX DS | naproxen sodium | TABLET;ORAL | 018164-003 | Sep 30, 1987 | ⤷ Try a Trial | ⤷ Try a Trial |
Twi Pharms | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-003 | Jan 5, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Atnahs Pharma Us | ANAPROX | naproxen sodium | TABLET;ORAL | 018164-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Twi Pharms | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-001 | Jan 5, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Atnahs Pharma Us | ANAPROX DS | naproxen sodium | TABLET;ORAL | 018164-003 | Sep 30, 1987 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for naproxen sodium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3061447 | SYSTÈME DE SOLVANT DESTINÉ À AMÉLIORER LA SOLUBILITÉ D'AGENTS PHARMACEUTIQUES (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS) | ⤷ Try a Trial |
Cyprus | 1118321 | ⤷ Try a Trial | |
Spain | 2606767 | ⤷ Try a Trial | |
Portugal | 1863458 | ⤷ Try a Trial | |
Poland | 1863458 | ⤷ Try a Trial | |
Lithuania | 1863458 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for naproxen sodium
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0984957 | SPC/GB11/013 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
1411900 | C300481 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105 |
1411900 | 2011/016 | Ireland | ⤷ Try a 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 |
1411900 | 2011C/016 | Belgium | ⤷ Try a Trial | PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214 |
1411900 | 18/2011 | Austria | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105 |
0984957 | 122012000051 | Germany | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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