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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.
US ANDA Litigation and 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-three 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 |
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 |
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 | Start Trial | Start Trial | Y | Start Trial | ||
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| >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 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 | Start Trial | Start Trial |
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | Start Trial | Start Trial |
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | Start Trial | Start Trial |
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | Start Trial | Start Trial |
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | Start Trial | Start Trial |
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIMOVO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2012531409 | Start Trial |
| Germany | 122012000017 | Start Trial |
| Czech Republic | 287876 | Start Trial |
| Lithuania | 1941 | Start Trial |
| New Zealand | 500991 | Start Trial |
| Germany | 69426254 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VIMOVO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0984957 | C300483 | Netherlands | Start Trial | PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524 |
| 0984957 | CA 2012 00008 | Denmark | Start Trial | |
| 1411900 | SPC/GB11/015 | United Kingdom | Start Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 1411900 | 91858 | Luxembourg | Start Trial | 91858, EXPIRES: 20251105 |
| 1020461 | C300482 | Netherlands | Start Trial | PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105 |
| 0984957 | 122012000051 | Germany | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
