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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.

US ANDA Litigation and Generic Entry Outlook for Vimovo

Vimovo was eligible for patent challenges on December 31, 1968.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2020. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $80mm indicating the motivation for generic entry (peak sales were $1.1bn in 2015).

There have been thirty-seven 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
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
Horizon Medicines LLC v. Ajanta Pharma Ltd.	2019-09-27
Aralez Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2017-01-23
ASTRAZENECA AB v. CIPLA LIMITED	2016-12-29

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

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

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		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

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	022511-001	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	022511-002	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

International Patents for VIMOVO

Country	Patent Number	Estimated Expiration
Israel	216877
Morocco	33553
Mexico	2011002515
Eurasian Patent Organization	201100313
Denmark	1411900

Supplementary Protection Certificates for VIMOVO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	2012/048	Ireland		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
1411900	91858	Luxembourg		91858, EXPIRES: 20251105
1411900	435	Finland
1411900	18/2011	Austria		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
1411900	C300481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105