ANAPROX DS Drug Patent Profile

When do Anaprox Ds patents expire, and what generic alternatives are available?

Anaprox Ds is a drug marketed by Atnahs Pharma Us and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Anaprox Ds

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

Summary for ANAPROX DS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	13
Patent Applications:	6,228
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ANAPROX DS
DailyMed Link:	ANAPROX DS at DailyMed

See drug prices for ANAPROX DS

Recent Clinical Trials for ANAPROX DS

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

Sponsor	Phase
Northwestern Medical Group	Phase 2
Shirley Ryan AbilityLab	Phase 2
Apkar Apkarian	Phase 4

See all ANAPROX DS clinical trials

Pharmacology for ANAPROX DS

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

Anatomical Therapeutic Chemical (ATC) Classes for ANAPROX DS

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

US Patents and Regulatory Information for ANAPROX DS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987	AB	RX	Yes	Yes

Expired US Patents for ANAPROX DS

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
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987

International Patents for ANAPROX DS

See the table below for patents covering ANAPROX DS around the world.

Country	Patent Number	Title	Estimated Expiration
Switzerland	520644	Verfahren zur Herstellung von a-(2-Naphtyl)- bzw. a-(3,4-Dihydro-2-naphthyl)-a-methyl-essigsäuren (2-Napthylacetic acid derivs. - analgesic, antipyretic antiinflammatory and antipruritic agents)
Switzerland	556810	VERFAHREN ZUR HERSTELLUNG DER D-2-(6-METHOXY-2-NAPHTHYL)-PROPIONSAEURE. (2-(6-Methoxy-2-naphthyl) propionic acid prepns. - anti-pyretics, analgesics, anti-inflammatory agents)
Switzerland	549544	VERFAHREN ZUR HERSTELLUNG VON 2-(6-METHOXY-2-NAPHTHYL)1-PROPANOL.

Supplementary Protection Certificates for ANAPROX DS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	122012000052	Germany		PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
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
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