Naproxen sodium - Generic Drug Details

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What are the generic drug sources for naproxen sodium and what is the scope of patent protection?

Naproxen sodium is the generic ingredient in nine branded drugs marketed by Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, Twi Pharms, 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, Hetero Labs Ltd V, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Norvium Bioscience, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Pliva, Purepac Pharm, Roxane, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva, Teva Pharms, Watson Labs, Yichang Humanwell, Aurobindo Pharma, Rising, Sun Pharm, and Currax, and is included in fifty-one NDAs. There are six 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 twenty-two drug master file entries for naproxen sodium. One hundred and thirty-three suppliers are listed for this compound.

Summary for naproxen sodium

International Patents:	15
US Patents:	6
Tradenames:	9
Applicants:	41
NDAs:	51
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	133
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	100
Patent Applications:	7,342
Drug Prices:	Drug price trends for naproxen sodium
Drug Sales Revenues:	Drug sales revenues for naproxen sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naproxen sodium
What excipients (inactive ingredients) are in naproxen sodium?	naproxen sodium excipients list
DailyMed Link:	naproxen sodium at DailyMed

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

Sponsor	Phase
Johnson & Johnson Consumer Inc. (J&JCI)	Phase 1
Johnson & Johnson Consumer Inc. (J&JCI)	Phase 3
Ciusss de L'Est de l'Île de Montréal	N/A

See all naproxen sodium clinical trials

Pharmacology for naproxen sodium

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for NAPROXEN SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAPROXEN SODIUM	Capsules	naproxen sodium	200 mg	021920	1	2017-11-15

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
Patheon Softgels	NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	214463-001	Jan 10, 2023		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer	ALEVE-D SINUS & COLD	naproxen sodium; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021076-001	Nov 29, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Sub Teva Pharms	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074230-001	Mar 14, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074480-001	May 14, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Purepac Pharm	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074319-001	Mar 20, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Catalent	NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	202807-001	Jan 4, 2019		OTC	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for naproxen sodium

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1863458	SYSTEME DE SOLVANT DESTINE A AMELIORER LA SOLUBILITE DES AGENTS PHARMACEUTIQUES (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS)	⤷ Sign Up
Denmark	1863458		⤷ Sign Up
Poland	1863458		⤷ Sign Up
Slovenia	1863458		⤷ Sign Up
China	101166520	Solvent system for enhancing the solubility of pharmaceutical agents	⤷ Sign Up
Portugal	1863458		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for naproxen sodium

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	122012000052	Germany	⤷ Sign Up	PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
0984957	122012000051	Germany	⤷ Sign Up	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	PA2011005,C0984957	Lithuania	⤷ Sign Up	PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957	CR 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
1411900	C300481	Netherlands	⤷ Sign Up	PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900	1190013-1	Sweden	⤷ Sign Up	PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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