DrugPatentWatch Database Preview
MIRVASO Drug Profile
Which patents cover Mirvaso, 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 eleven patent family members in thirty countries.
The generic ingredient in MIRVASO is brimonidine tartrate. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.
Summary for MIRVASO
| International Patents: | 111 |
| 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 |
| Skin Laser & Surgery Specialists | N/A |
Recent Litigation for MIRVASO
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Galderma Laboratories, L.P. v. Perrigo UK FINCO L.P. | 2016-08-19 |
| Galderma Laboratories LP v. Actavis Laboratories UT Inc. | 2015-03-12 |
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 |
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 | 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 | 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 |
|---|---|---|
| Australia | 2011231543 | Start Trial |
| Spain | 2424644 | Start Trial |
| Israel | 225760 | Start Trial |
| Hungary | E027616 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MIRVASO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1631293 | 2014C/042 | Belgium | Start Trial | PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221 |
| 1631293 | C20140022 00150 | Estonia | Start Trial | PRODUCT NAME: BRIMONIDIIN;REG NO/DATE: K(2014)1313 (LOPLIK) 25.02.2014 |
| 1631293 | C300683 | Netherlands | Start Trial | PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225 |
| 1631293 | 191 5019-2014 | Slovakia | Start Trial | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
