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VIMOVO Drug Profile

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

Vimovo is a drug marketed by Horizon and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-one patent family members in twenty-three countries.

The generic ingredient in VIMOVO is esomeprazole magnesium; naproxen. There are seventy-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.

Summary for VIMOVO

International Patents:	51
US Patents:	11
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	11
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VIMOVO
Drug Sales Revenues:	Drug sales revenues for VIMOVO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIMOVO
DailyMed Link:	VIMOVO at DailyMed

See drug prices for VIMOVO

See drug sales revenues for VIMOVO

Generic Entry Opportunity Date for VIMOVO

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

022511

Dosage:

TABLET, DELAYED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VIMOVO

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

Sponsor	Phase
EMS	Phase 3
Hanyang University Seoul Hospital	Phase 2
Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 4

See all VIMOVO clinical trials

Recent Litigation for VIMOVO

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Aralez Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2017-01-23
ASTRAZENECA AB v. CIPLA LIMITED	2016-12-29
AUROBINDO PHARMA LIMITED v. ASTRAZENECA AB	2016-08-18

See all VIMOVO litigation

PTAB Litigation

Petitioner	Date
Dr. Reddy's Lab., Inc.	2018-07-02
Dr. Reddy's Laboratories, Inc.	2018-04-06
Mylan Pharmaceuticals Inc.	2017-12-04

See all VIMOVO litigation

Pharmacology for VIMOVO

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

US Patents and Regulatory Information for VIMOVO

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

Expired US Patents for VIMOVO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010

Paragraph IV (Patent) Challenges for VIMOVO

Drugname	Dosage	Strength	RLD	Date
	Delayed-release Tablet	375 mg/20 mg and 500 mg/20 mg

International Patents for VIMOVO

Country	Patent Number	Estimated Expiration
Cyprus	1110842
Israel	216877
South Korea	20120030106
South Africa	201102645
Singapore	176724
Canada	2764963

Supplementary Protection Certificates for VIMOVO

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
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	435	Finland
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
1411900	1190013-1	Sweden		PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105