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 |
| Skin Laser & Surgery Specialists | 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 | 2004242967 | Compounds, formulations, and methods for treating or preventing rosacea | ⤷ Try a Trial |
| New Zealand | 544300 | Compounds, formulations, and methods for treating or preventing rosacea | ⤷ Try a Trial |
| China | 106038476 | Methods and compositions for safe and effective treatment of erythema | ⤷ Try a Trial |
| New Zealand | 552325 | The use of alpha 2 andrenoceptor agonists such as brimonidine for treating inflammatory skin disorders | ⤷ Try a Trial |
| Portugal | 2815748 | ⤷ 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 | 1490049-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221 |
| 1631293 | C20140022 00150 | Estonia | ⤷ Try a Trial | PRODUCT NAME: BRIMONIDIIN;REG NO/DATE: K(2014)1313 (LOPLIK) 25.02.2014 |
| 1631293 | 122014000080 | Germany | ⤷ Try a Trial | PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/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 |
| 1631293 | 14C0056 | France | ⤷ Try a Trial | PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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ISSN: 2162-2639
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