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Naproxen sodium - Generic Drug Details
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 nine branded drugs marketed by Bionpharma Inc, Puracap Pharm Llc, Alvogen Malta, 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, Perrigo, Pld Acquisitions Llc, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Ltd, Teva, Teva Pharms, Watson Labs, Mylan Pharms Inc, Sun Pharma Global, and Pernix Ireland Ltd, and is included in forty-three NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are forty-two drug master file entries for naproxen sodium. One hundred and sixty suppliers are listed for this compound.
Summary for naproxen sodium
| US Patents: | 9 |
| Tradenames: | 9 |
| Applicants: | 33 |
| NDAs: | 43 |
| Drug Master File Entries: | 42 |
| Suppliers / Packagers: | 160 |
| Bulk Api Vendors: | 65 |
| Clinical Trials: | 76 |
| Patent Applications: | 7,568 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for naproxen sodium |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for naproxen sodium |
| DailyMed Link: | naproxen sodium at DailyMed |
Pharmacology for naproxen sodium
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Synonyms for naproxen sodium
| (-)-Naproxen sodium |
| (-)-Sodium (S)-6-methoxy-alpha-methyl-2-naphthaleneacetate |
| (2S)-2-(6-Methoxy-2-naphthyl)propanoic acid sodium salt |
| (2s)-2-(6-methoxy(2-naphthyl))propanoic acid sodium salt |
| (S)-6-Methoxy-|A-methyl-2-naphthaleneacetic acid sodium salt |
| (S)-6-Methoxy-alpha-methyl-2-naphthaleneacetic acid sodium |
| (S)-6-Methoxy-alpha-methyl-2-naphthaleneacetic acid sodium salt |
| (S)-Naproxen Sodium Salt |
| 2-Naphthaleneacetic acid, 6-methoxy-alpha-methyl-, sodium salt, (S)- |
| 2-NAPHTHALENEACETIC ACID, 6-METHOXY-alpha-METHYL-, SODIUM SALT, L-(-)- |
| 26159-34-2 |
| 59N342 |
| 9TN87S3A3C |
| A-Nox |
| A818221 |
| AB0013373 |
| AB2000172 |
| AC1Q1V3H |
| AK163551 |
| AKOS015895696 |
| AKOS015994759 |
| Anapran |
| Anaprotab |
| Anaprox |
| Anaprox (TN) |
| ANAPROX DS |
| API0003516 |
| Apo-Napro-NA |
| Aprol |
| Aprowell |
| Axer Alfa |
| BAY H6689 |
| BAYH6689 |
| BCP0726000300 |
| BCP9000977 |
| BIM-0050769.0001 |
| C-15574 |
| C14H13NaO3 |
| C14H13O3.Na |
| CAS-26159-34-2 |
| Causalon Pro |
| CC-32459 |
| CCG-101082 |
| CDBRNDSHEYLDJV-FVGYRXGTSA-M |
| CHEBI:7477 |
| CHEMBL1200806 |
| CPD000058746 |
| CS-2162 |
| CTK8G1633 |
| D00970 |
| D09CGL |
| Daio-Orengedokuto (DOT) |
| Diocodal |
| DSSTox_CID_25576 |
| DSSTox_GSID_45576 |
| DSSTox_RID_80973 |
| DTXSID7045576 |
| Dysmenalgit |
| EINECS 247-486-2 |
| EU-0100792 |
| Flanax |
| Flogen |
| Floginex |
| Flogogin |
| Floneks |
| Floxalin |
| FT-0630524 |
| Gibinap |
| Gibixen |
| H939 |
| HMS1570O04 |
| HMS2052G05 |
| HMS2230D08 |
| HMS3262O06 |
| HMS3269J19 |
| HY-15030A |
| J10445 |
| Kapnax |
| Karoksen |
| KS-00000XJS |
| KS-5141 |
| L-(-)-6-Methoxy-alpha-methyl-2-naphthaleneacetic acid sodium salt |
| Laser |
| Leniartril |
| Lopac-M-1275 |
| LP00792 |
| LS-94350 |
| M 1275 |
| MFCD00058507 |
| Miranax |
| MLS000069555 |
| MLS001076076 |
| MLS001424214 |
| MolPort-003-849-327 |
| Monarit |
| Naprelan |
| Naprium |
| Naprodil |
| Naprodol |
| Naprovite |
| Naproxen (Aleve) |
| Naproxen (sodium) |
| Naproxen natrium |
| Naproxen sodium (USP) |
| Naproxen sodium [USAN:USP] |
| Naproxen sodium [USAN] |
| Naproxen sodium salt |
| Naproxen sodium, 98.0-102.0% |
| Naproxen sodium, meets USP testing specifications |
| Naproxen sodium, pharmaceutical secondary standard; traceable to USP |
| Naproxen sodium, United States Pharmacopeia (USP) Reference Standard |
| NAPROXEN SODIUM,98% |
| Naproxensodium |
| Naprux |
| Naprux Gesic |
| Natrioxen |
| NC00332 |
| NCGC00016166-01 |
| NCGC00016759-04 |
| NCGC00017097-01 |
| NCGC00017097-02 |
| NCGC00094127-01 |
| NCGC00261477-01 |
| Nixal |
| Opera_ID_1200 |
| Opraks |
| OR249863 |
| Pactens |
| Prexan |
| Primeral |
| Proxen |
| PubChem19878 |
| RS 3650 |
| RS-3650 |
| S1626 |
| SAM001246874 |
| SCHEMBL7361 |
| SMR000058746 |
| Sodimax |
| Sodium (-)-2-(6-methoxy-2-naphthyl)propionate |
| sodium (2S)-2-(6-methoxy-2-naphthalenyl)propanoate |
| sodium (2S)-2-(6-methoxy-2-naphthyl)propanoate |
| sodium (2S)-2-(6-methoxynaphthalen-2-yl)propanoate |
| sodium (S)-2-(6-methoxy-2-naphthyl)propionate |
| sodium (S)-2-(6-methoxynaphthalen-2-yl)propanoate |
| sodium naproxen |
| sodium;(2S)-2-(6-methoxynaphthalen-2-yl)propanoate |
| ST51052889 |
| Sunprox |
| Synflex |
| Tandax |
| Topcare all day pain relief |
| Tox21_110774 |
| Tox21_110774_1 |
| Tox21_500792 |
| UNII-9TN87S3A3C |
| UNM-0000306098 |
| VA11355 |
| Veradol |
| W-107195 |
| Xenar |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 200629-001 | Oct 31, 2011 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Contract Pharmacal | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074635-001 | Jan 13, 1997 | OTC | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Watson Labs | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074195-002 | Dec 21, 1993 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Bionpharma Inc | NAPROXEN SODIUM | naproxen sodium | CAPSULE;ORAL | 021920-001 | Feb 17, 2006 | OTC | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Teva | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074142-001 | Dec 21, 1993 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Aurobindo Pharma Ltd | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 205497-001 | Mar 18, 2016 | OTC | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Teva | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074198-002 | Dec 21, 1993 | AB | RX | 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 |
|---|---|---|---|---|---|---|---|
| Alvogen Malta | 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 |
| Atnahs Pharma Us | ANAPROX DS | naproxen sodium | TABLET;ORAL | 018164-003 | Sep 30, 1987 | ➤ Sign Up | ➤ Sign Up |
| Atnahs Pharma Us | ANAPROX DS | naproxen sodium | TABLET;ORAL | 018164-003 | Sep 30, 1987 | ➤ Sign Up | ➤ Sign Up |
| Atnahs Pharma Us | ANAPROX DS | naproxen sodium | TABLET;ORAL | 018164-003 | Sep 30, 1987 | ➤ 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 | Document Number | Estimated Expiration |
|---|---|---|
| China | 102940887 | ➤ Sign Up |
| Mexico | 2007011039 | ➤ Sign Up |
| China | 101166520 | ➤ Sign Up |
| Portugal | 1863458 | ➤ Sign Up |
| Poland | 1863458 | ➤ Sign Up |
| Denmark | 1863458 | ➤ Sign Up |
| Slovenia | 1863458 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for naproxen sodium
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C/GB11/015 | United Kingdom | ➤ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 90013-1 | Sweden | ➤ Sign Up | PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105 |
| C/GB11/013 | United Kingdom | ➤ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 1411900/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011 |
| 00481 | Netherlands | ➤ Sign Up | PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105 |
| 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 |
| 2011005,C0984957 | Lithuania | ➤ Sign Up | PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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