MIRVASO Drug Patent Profile
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When do Mirvaso patents expire, and what generic alternatives are available?
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 twenty-four 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. Fifteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.
DrugPatentWatch® 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: | 124 |
US Patents: | 12 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 104 |
Clinical Trials: | 12 |
Patent Applications: | 1,636 |
Drug Prices: | Drug price information for MIRVASO |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MIRVASO |
What excipients (inactive ingredients) are in MIRVASO? | MIRVASO excipients list |
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 R&D | N/A |
Pharmacology for MIRVASO
Drug Class | alpha-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for MIRVASO
Paragraph IV (Patent) Challenges for MIRVASO
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MIRVASO | Topical Gel | brimonidine tartrate | 0.33% | 204708 | 1 | 2014-12-15 |
US Patents and Regulatory Information for MIRVASO
MIRVASO is protected by twelve US patents.
Patents protecting MIRVASO
Brimonidine gel compositions and methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds, formulations, and methods for treating or preventing rosacea
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Brimonidine gel composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Gel compositions and methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds, formulations, and methods for ameliorating telangiectasis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods and compositions for treating or preventing erythema
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Methods and compositions for safe and effective treatment of erythema
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Methods and compositions for safe and effective treatment of erythema
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Methods and compositions for safe and effective treatment of erythema
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Methods and compositions for safe and effective treatment of erythema
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
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 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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
See the table below for patents covering MIRVASO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2005247467 | Compounds, formulations, and methods for treating or preventing inflammatory skin disorders | ⤷ Try a Trial |
Norway | 333468 | ⤷ Try a Trial | |
Denmark | 1631293 | ⤷ Try a Trial | |
Mexico | 354697 | COMPOSICIONES DE GEL DE BRIMONIDINA Y MÉTODOS DE USO. (BRIMONIDINE GEL COMPOSITIONS AND METHODS OF USE.) | ⤷ Try a Trial |
Poland | 1631293 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MIRVASO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1631293 | 2014/041 | Ireland | ⤷ Try a Trial | PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221 |
1631293 | C 2014 030 | Romania | ⤷ Try a Trial | PRODUCT NAME: BRIMONIDINA SI SARURILE FARMACEUTICE ALE ACESTEIA5-BROMO-N-(4,5-DIHIDRO-1-H-IMIDAZOL-2-IL)QUINOXALIN-6-AMINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/904; DATE OF NATIONAL AUTHORISATION: 20140221; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/904; DATE OF FIRST AUTHORISATION IN EEA: 20140221 |
1631293 | 122014000080 | Germany | ⤷ Try a Trial | PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221 |
1631293 | 2014C/042 | Belgium | ⤷ Try a 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 | CR 2014 00031 | Denmark | ⤷ Try a Trial | PRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |