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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, 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, and Pernix Ireland Ltd, and is included in forty NDAs. There are seven 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-five suppliers are listed for this compound.

Summary for naproxen sodium

International Patents:	15
US Patents:	7
Tradenames:	9
Applicants:	30
NDAs:	40
Drug Master File Entries:	42
Suppliers / Packagers:	155
Bulk Api Vendors:	61
Clinical Trials:	2,602
Patent Applications:	7,451
Formulation / Manufacturing:	see details
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Able	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	076544-002	Aug 22, 2003		DISCN	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Alvogen Malta	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996	AB	RX	Yes	Yes	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Hamilton Pharms	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074106-002	Aug 31, 1993		DISCN	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Perrigo	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074661-001	Jan 13, 1997		OTC	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

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Expired US Patents for naproxen sodium

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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 Free Trial	➤ Try a Free Trial
Alvogen Malta	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996	➤ Try a Free Trial	➤ Try a Free Trial
Alvogen Malta	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-001	Jan 5, 1996	➤ Try a Free Trial	➤ Try a Free Trial
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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International Patents for naproxen sodium

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Country	Document Number	Estimated Expiration
Hungary	E030784	➤ Try a Free Trial
China	102940887	➤ Try a Free Trial
Mexico	2007011039	➤ Try a Free Trial
China	101166520	➤ Try a Free Trial
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for naproxen sodium

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB11/015	United Kingdom	➤ Try a Free Trial	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
90013-1	Sweden	➤ Try a Free Trial	PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
2011005	Lithuania	➤ Try a Free Trial	PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
11/016	Ireland	➤ Try a Free 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
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description