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MIRVASO Drug Profile
» See Plans and Pricing
When do Mirvaso patents expire, and when can generic versions of Mirvaso launch?
Mirvaso is a drug marketed by Galderma Labs Lp and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and nineteen patent family members in thirty-one countries.
The generic ingredient in MIRVASO is brimonidine tartrate. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.
US ANDA Litigation and Generic Entry Outlook for Mirvaso
A generic version of MIRVASO was approved as brimonidine tartrate by BAUSCH AND LOMB on May 28th, 2003.
Summary for MIRVASO
| International Patents: | 119 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 100 |
| Clinical Trials: | 11 |
| Drug Prices: | Drug price information for MIRVASO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MIRVASO |
| DailyMed Link: | MIRVASO at DailyMed |
Recent Clinical Trials for MIRVASO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Francisco | Early Phase 1 |
| Heinrich-Heine University, Duesseldorf | Phase 2 |
| Galderma | N/A |
Pharmacology for MIRVASO
| Drug Class | alpha-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists |
Paragraph IV (Patent) Challenges for MIRVASO
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MIRVASO | GEL;TOPICAL | brimonidine tartrate | 204708 | 2014-12-15 |
US Patents and Regulatory Information for MIRVASO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | 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 |
International Patents for MIRVASO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20070032716 | Start Trial |
| Poland | 2388007 | Start Trial |
| China | 1829518 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MIRVASO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1631293 | C01631293/01 | Switzerland | Start Trial | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014 |
| 1631293 | 92462 | Luxembourg | Start Trial | PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225 |
| 1631293 | 1490049-2 | Sweden | Start Trial | PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
