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Last Updated: November 13, 2019

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NAPROXEN SODIUM Drug Profile

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Which patents cover Naproxen Sodium, and what generic alternatives are available?

Naproxen Sodium is a drug marketed by Bionpharma Inc, Catalent, Puracap Pharm Llc, Actavis Labs Fl Inc, 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, Yichang Humanwell, Amneal Pharms Co, Apotex Inc, P And L, and Perrigo R And D. and is included in forty-two NDAs. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has fifteen patent family members in thirteen countries.

The generic ingredient in NAPROXEN SODIUM is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.

Drug patent expirations by year for NAPROXEN SODIUM
Drug Prices for NAPROXEN SODIUM

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Drug Sales Revenue Trends for NAPROXEN SODIUM

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Recent Clinical Trials for NAPROXEN SODIUM

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SponsorPhase
Massachusetts General HospitalPhase 4
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionPhase 2
McNeil ABPhase 1

See all NAPROXEN SODIUM clinical trials

Recent Litigation for NAPROXEN SODIUM

Identify potential future generic entrants

District Court Litigation
Case NameDate
PATHEON SOFTGELS INC. v. PURACAP PHARMACEUTICAL LLC2018-10-05
PATHEON SOFTGELS INC. v. OHM LABORATORIES INC.2018-01-12
Patheon Softgels Inc. v. Apotex Inc.2018-01-02

See all NAPROXEN SODIUM litigation

PTAB Litigation
PetitionerDate
Catalent Pharma Solutions, Inc.2018-01-14

See all NAPROXEN SODIUM litigation

Pharmacology for NAPROXEN SODIUM
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
AKOS015895696
AKOS015994759
Aleve
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
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, 98%
Naproxen sodium, meets USP testing specifications
Naproxen sodium, Pharmaceutical Secondary Standard; Certified Reference Material
Naproxen sodium, United States Pharmacopeia (USP) Reference Standard
Naproxen Sodium,(S)
Naprux
Naprux Gesic
Natrioxen
NC00332
NCGC00016166-01
NCGC00016759-04
NCGC00017097-01
NCGC00017097-02
NCGC00094127-01
NCGC00261477-01
Nixal
Opera_ID_1200
Opraks
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
Sunprox
SW197105-3
Synflex
Tandax
Topcare all day pain relief
Tox21_110774
Tox21_110774_1
Tox21_500792
UNII-9TN87S3A3C
UNM-0000306098
VA11355
Veradol
W-107195
Xenar
Paragraph IV (Patent) Challenges for NAPROXEN SODIUM
Tradename Dosage Ingredient NDA Submissiondate
NAPROXEN SODIUM CAPSULE;ORAL naproxen sodium 021920 2017-11-15
NAPRELAN TABLET, EXTENDED RELEASE;ORAL naproxen sodium 020353

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
Pliva NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074242-001 Jun 20, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074230-001 Mar 14, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074162-002 Dec 21, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074195-002 Dec 21, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Roxane NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074257-001 Dec 21, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for NAPROXEN SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 122012000052 Germany   Start Trial PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1411900 18/2011 Austria   Start 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   Start 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
0984957 CR 2012 00035 Denmark   Start Trial 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
0984957 PA2011005 Lithuania   Start Trial PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Boehringer Ingelheim
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Harvard Business School

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