DrugPatentWatch Database Preview

Naproxen sodium - Generic Drug Details

« Back to Dashboard

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, Novelgenix Theraps, 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-four NDAs. There are nine 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 fifty-nine suppliers are listed for this compound.

Summary for naproxen sodium

International Patents:	15
US Patents:	9
Tradenames:	9
Applicants:	34
NDAs:	44
Drug Master File Entries:	42
Suppliers / Packagers:	159
Bulk Api Vendors:	68
Clinical Trials:	76
Patent Applications:	7,510
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
Teva	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074198-002	Dec 21, 1993	AB	RX	No	No
Pernix Ireland Ltd	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015		DISCN	Yes	No
Sandoz	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074495-002	Dec 5, 1994		DISCN	No	No
Contract Pharmacal	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074635-001	Jan 13, 1997		OTC	No	No
Hamilton Pharms	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074106-002	Aug 31, 1993		DISCN	No	No
Glenmark Pharms Ltd	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	078314-002	Apr 27, 2007	AB	RX	No	No

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
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982
Alvogen Malta	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-002	Jan 5, 1996

International Patents for naproxen sodium

Country	Document Number	Estimated Expiration
Mexico	2007011039
Slovenia	1863458
China	102940887
China	101166520
Lithuania	1863458
World Intellectual Property Organization (WIPO)	2006096580

Supplementary Protection Certificates for naproxen sodium

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2012000051	Germany		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
C/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
90013-1	Sweden		PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
2012 00035	Denmark		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
11/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
2011005	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126