Esomeprazole magnesium; naproxen - Generic Drug Details

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What are the generic sources for esomeprazole magnesium; naproxen and what is the scope of patent protection?

Esomeprazole magnesium; naproxen is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Dr Reddys, Mylan, and Horizon, and is included in five NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Esomeprazole magnesium; naproxen has fifty-one patent family members in twenty-four countries.

Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for esomeprazole magnesium; naproxen

International Patents:	51
US Patents:	9
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for esomeprazole magnesium; naproxen
DailyMed Link:	esomeprazole magnesium; naproxen at DailyMed

Generic filers with tentative approvals for ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for esomeprazole magnesium; naproxen

Drug Class	Nonsteroidal Anti-inflammatory Drug Proton Pump Inhibitor
Mechanism of Action	Cyclooxygenase Inhibitors Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for esomeprazole magnesium; naproxen

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

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

Paragraph IV (Patent) Challenges for ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIMOVO	Delayed-release Tablets	esomeprazole magnesium; naproxen	375 mg/20 mg and 500 mg/20 mg	022511	1	2010-11-05

US Patents and Regulatory Information for esomeprazole magnesium; naproxen

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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
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	AB	RX	Yes	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 esomeprazole magnesium; naproxen

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	⤷ Sign Up	⤷ Sign Up
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	⤷ Sign Up	⤷ Sign Up
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for esomeprazole magnesium; naproxen

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Country	Patent Number	Title	Estimated Expiration
China	102209529	Method for delivering a pharmaceutical composition to patient in need thereof	⤷ Sign Up
Japan	2004536809		⤷ Sign Up
Eurasian Patent Organization	006398	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ КООРДИНИРОВАННОЙ ДОСТАВКИ НЕСТЕРОИДНЫХ ПРОТИВОВОСПАЛИТЕЛЬНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ (PHARMACEUTICAL COMPOSITIONS FOR COORDINATED DELIVERY OF NSAIDS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for esomeprazole magnesium; naproxen

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	18/2011	Austria	⤷ Sign Up	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	2012/048	Ireland	⤷ Sign Up	PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
0984957	SPC/GB11/013	United Kingdom	⤷ Sign Up	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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