NAPRELAN Drug Patent Profile

When do Naprelan patents expire, and when can generic versions of Naprelan launch?

Naprelan is a drug marketed by Twi Pharms and is included in one NDA.

The generic ingredient in NAPRELAN is naproxen sodium. There are forty-two drug master file entries for this compound. One hundred and thirty-three suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naprelan

A generic version of NAPRELAN was approved as naproxen sodium by CONTRACT PHARMACAL on January 13^th, 1997.

Summary for NAPRELAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	8
Patent Applications:	6,228
Drug Prices:	Drug price information for NAPRELAN
Drug Sales Revenues:	Drug sales revenues for NAPRELAN
What excipients (inactive ingredients) are in NAPRELAN?	NAPRELAN excipients list
DailyMed Link:	NAPRELAN at DailyMed

See drug prices for NAPRELAN

See drug sales revenues for NAPRELAN

Recent Clinical Trials for NAPRELAN

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

Sponsor	Phase
Northwestern Medical Group	Phase 2
Apkar Apkarian	Phase 4
National Institute of Dental and Craniofacial Research (NIDCR)	Phase 4

See all NAPRELAN clinical trials

Pharmacology for NAPRELAN

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

US Patents and Regulatory Information for NAPRELAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-001	Jan 5, 1996	AB	RX	Yes	No
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-002	Jan 5, 1996	AB	RX	Yes	No
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996	AB	RX	Yes	Yes

Expired US Patents for NAPRELAN

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
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-002	Jan 5, 1996

International Patents for NAPRELAN

See the table below for patents covering NAPRELAN around the world.

Country	Patent Number	Title	Estimated Expiration
Ireland	900149
European Patent Office	0438249	Formule de naproxen à absorption controlée pour l'administration une fois par jour. (Controlled absorption naproxen formulation for once-daily administration.)
Spain	2075338
Ireland	66933	Controlled absorption naproxen formulation for once-daily administration
Denmark	0438249
Australia	639519

Supplementary Protection Certificates for NAPRELAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	122012000051	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
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
0984957	CR 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
1411900	C300481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
0984957	PA2011005,C0984957	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105