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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 |
Generic Entry Opportunity Date for VIMOVO
Generic Entry Date for VIMOVO*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION NDA:
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 |
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 |
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 |
Pharmacology for VIMOVO
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 | Start Trial | Start Trial | Y | Start Trial | |||
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | RX | Yes | No | Start Trial | Start Trial | 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 | 022511-001 | 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 | 022511-001 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIMOVO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2010263304 | Start Trial |
| Israel | 216877 | Start Trial |
| Japan | 2012531409 | Start Trial |
| Singapore | 176724 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VIMOVO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1411900 | C01411900/01 | Switzerland | Start Trial | PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011 |
| 1411900 | 435 | Finland | Start Trial | |
| 1411900 | 2011/016 | Ireland | Start Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105 |
| 1411900 | C300481 | Netherlands | Start Trial | PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
