Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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Naproxen sodium - Generic Drug Details

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What are the generic 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 Inc, Catalent, Puracap Pharm Llc, Alvogen, 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, Yichang Humanwell, Sun Pharm, and Currax, and is included in forty-six NDAs. There are five 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 thirty-seven suppliers are listed for this compound.

Drug Prices for naproxen sodium

See drug prices for naproxen sodium

Drug Sales Revenue Trends for naproxen sodium

See drug sales revenues for naproxen sodium

Recent Clinical Trials for naproxen sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institutes of Health (NIH)Phase 4
NorthShore University HealthSystemPhase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 4

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
Actavis Labs Fl Inc NAPROXEN SODIUM naproxen sodium TABLET, EXTENDED RELEASE;ORAL 075416-002 Apr 23, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074455-002 May 31, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Able NAPROXEN SODIUM naproxen sodium TABLET;ORAL 076544-001 Aug 22, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Hamilton Pharms NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074106-002 Aug 31, 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

Expired US Patents for naproxen sodium

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   Start Trial   Start Trial
Alvogen NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-001 Jan 5, 1996   Start Trial   Start Trial
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987   Start Trial   Start Trial
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987   Start Trial   Start Trial
Atnahs Pharma Us ANAPROX naproxen sodium TABLET;ORAL 018164-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for naproxen sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1411900 1190013-1 Sweden   Start Trial PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
1411900 2011/016 Ireland   Start 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
0984957 SPC/GB11/013 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957 PA2011005,C0984957 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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Harvard Business School
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