brimonidine tartrate - Profile
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What are the generic sources for brimonidine tartrate and what is the scope of patent protection?
Brimonidine tartrate
is the generic ingredient in eleven branded drugs marketed by Padagis Israel, Galderma Labs Lp, Allergan, Abbvie, Alembic, Apotex, Bausch And Lomb, Dr Reddys Labs Sa, Gland, Lupin, Mankind Pharma, Micro Labs, Regcon Holdings, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Upsher Smith Labs, Bausch And Lomb Inc, Alcon Labs Inc, Visus, Amneal, Caplin, Glenmark Pharms Ltd, Sentiss, and Somerset, and is included in forty-three NDAs. There are fifteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Brimonidine tartrate has one hundred and sixty-three patent family members in thirty-two countries.
There is one tentative approval for this compound.
Summary for brimonidine tartrate
| International Patents: | 163 |
| US Patents: | 15 |
| Tradenames: | 11 |
| Applicants: | 26 |
| NDAs: | 43 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for brimonidine tartrate |
Generic filers with tentative approvals for BRIMONIDINE TARTRATE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 0.2%; 0.5% | SOLUTION; OPHTHALMIC |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| QOLIANA | Ophthalmic Solution | brimonidine tartrate | 0.15% | 021764 | 1 | 2023-10-24 |
| LUMIFY | Ophthalmic Solution | brimonidine tartrate | 0.025% | 208144 | 1 | 2021-07-12 |
| MIRVASO | Topical Gel | brimonidine tartrate | 0.33% | 204708 | 1 | 2014-12-15 |
| ALPHAGAN P | Ophthalmic Solution | brimonidine tartrate | 0.1% | 021770 | 1 | 2006-12-20 |
| ALPHAGAN P | Ophthalmic Solution | brimonidine tartrate | 0.15% | 021262 | 1 | 2006-11-03 |
US Patents and Regulatory Information for brimonidine tartrate
Expired US Patents for brimonidine tartrate
| 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 | 8,426,410 | ⤷ Start Trial |
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | 7,439,241 | ⤷ Start Trial |
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | 8,859,551 | ⤷ Start Trial |
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | 8,410,102 | ⤷ Start Trial |
| Abbvie | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021770-001 | Aug 19, 2005 | 10,307,368 | ⤷ Start Trial |
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | 8,231,885 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for brimonidine tartrate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2014039635 | ⤷ Start Trial | |
| Canada | 2832953 | ⤷ Start Trial | |
| Canada | 2814952 | ⤷ Start Trial | |
| South Africa | 201402758 | BRIMONIDINE GEL COMPOSITIONS AND METHODS OF USE | ⤷ Start Trial |
| Russian Federation | 2571277 | КОМПОЗИЦИИ ГЕЛЯ С БРИМОНИДИНОМ И СПОСОБЫ ПРИМЕНЕНИЯ (GEL COMPOSITIONS WITH BRIMONIDINE AND METHODS OF APPLICATION) | ⤷ Start Trial |
| Denmark | 2815748 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for brimonidine tartrate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1631293 | 191 5019-2014 | Slovakia | ⤷ Start Trial | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221 |
| 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 | 45/2014 | Austria | ⤷ Start Trial | PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCHE GEEIGNETE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904/001-003 20140221 |
| 1631293 | 201440029 | Slovenia | ⤷ Start Trial | PRODUCT NAME: BRIMONIDINE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS; NATIONAL AUTHORISATION NUMBER: EU/1/13/904/001-003; DATE OF NATIONAL AUTHORISATION: 20140221; AUTHORITY FOR NATIONAL AUTHORISATION: EU |
| 1631293 | 132014902284452 | Italy | ⤷ Start Trial | PRODUCT NAME: BRIMONIDINA(MIRVASO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/904/001-002-003, 20140221 |
| 1631293 | C01631293/01 | Switzerland | ⤷ Start Trial | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Brimonidine Tartrate: Investment Scenario, Market Dynamics, and Financial Trajectory
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