MIRVASO Drug Patent Profile
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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 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.
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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 | 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 | 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds, formulations, and methods for treating or preventing rosacea
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Brimonidine gel composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Gel compositions and methods of use
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds, formulations, and methods for ameliorating telangiectasis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods and compositions for treating or preventing erythema
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Methods and compositions for safe and effective treatment of erythema
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Methods and compositions for safe and effective treatment of erythema
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Methods and compositions for safe and effective treatment of erythema
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Methods and compositions for safe and effective treatment of erythema
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >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 MIRVASO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MIRVASO
See the table below for patents covering MIRVASO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 4955543 | ⤷ Sign Up | |
| Australia | 2011231543 | Improved methods and compositions for safe and effective treatment of erythema | ⤷ Sign Up |
| Australia | 2011317554 | Brimonidine gel compositions and methods of use | ⤷ Sign Up |
| Russian Federation | 2012145616 | УСОВЕРШЕНСТВОВАННЫЕ СПОСОБЫ И КОМПОЗИЦИИ ДЛЯ БЕЗОПАСНОГО И ЭФФЕКТИВНОГО ЛЕЧЕНИЯ ЭРИТЕМЫ | ⤷ Sign Up |
| Poland | 2444068 | ⤷ Sign Up | |
| South Korea | 20130002338 | IMPROVED METHODS AND COMPOSITIONS FOR SAFE AND EFFECTIVE TREATMENT OF ERYTHEMA | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MIRVASO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1631293 | C300683 | Netherlands | ⤷ Sign Up | 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 | 122014000080 | Germany | ⤷ Sign Up | PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221 |
| 1631293 | 2014/041 | Ireland | ⤷ Sign Up | PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221 |
| 1631293 | 92462 | Luxembourg | ⤷ Sign Up | 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 | 191 5019-2014 | Slovakia | ⤷ Sign Up | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221 |
| 1631293 | CR 2014 00031 | Denmark | ⤷ Sign Up | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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