NAPROXEN SODIUM - Generic Drug Details
✉ Email this page to a colleague
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, 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, 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, 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-three 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: | 133 |
Raw Ingredient (Bulk) Api Vendors: | 93 |
Clinical Trials: | 100 |
Patent Applications: | 7,342 |
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 |
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Currax | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-001 | Apr 15, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Aurobindo Pharma | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | naproxen sodium; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211360-001 | Jun 1, 2022 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Puracap Pharm Llc | NAPROXEN SODIUM | naproxen sodium | CAPSULE;ORAL | 208363-001 | Mar 15, 2018 | OTC | 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 |
Expired US Patents for NAPROXEN SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Twi Pharms | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-001 | Jan 5, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Atnahs Pharma Us | ANAPROX | naproxen sodium | TABLET;ORAL | 018164-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Atnahs Pharma Us | ANAPROX | naproxen sodium | TABLET;ORAL | 018164-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NAPROXEN SODIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Lithuania | 1863458 | ⤷ Sign Up | |
Mexico | 2007011039 | SISTEMA DE SOLVENTE PARA AUMENTAR LA SOLUBILIDAD DE AGENTES FARMACEUTICOS. (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS.) | ⤷ 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 | 2011C/016 | Belgium | ⤷ Sign Up | PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214 |
1411900 | 2011/016 | Ireland | ⤷ Sign Up | 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 | 122012000051 | Germany | ⤷ Sign Up | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.