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VIMOVO Drug Profile

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Which patents cover Vimovo, 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. Two suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.

DrugPatentWatch^® Generic Entry Outlook for Vimovo

Annual sales in 2018 were $426mm indicating the motivation for generic entry (peak sales were $1.1bn in 2015).

There have been thirty-five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (esomeprazole magnesium; naproxen), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for VIMOVO

International Patents:	51
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product 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
What excipients (inactive ingredients) are in VIMOVO?	VIMOVO excipients list
DailyMed Link:	VIMOVO at DailyMed

See drug prices for VIMOVO

See drug sales revenues for VIMOVO

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

Paragraph IV (Patent) Challenges for VIMOVO

Tradename	Dosage	Ingredient	NDA	Submissiondate
VIMOVO	TABLET, DELAYED RELEASE;ORAL	esomeprazole magnesium; naproxen	022511	2010-11-05

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

International Patents for VIMOVO

Country	Patent Number	Estimated Expiration
Serbia	20070459
Slovenia	22752
European Patent Office	1020461
Spain	2100136
Eurasian Patent Organization	201290026

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
0984957	1290006-4	Sweden		PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
1411900	91858	Luxembourg		91858, EXPIRES: 20251105
0984957	92017	Luxembourg		92017, EXPIRES: 20230525
1411900	2011/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105