BRIMONIDINE TARTRATE Drug Patent Profile
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When do Brimonidine Tartrate patents expire, and when can generic versions of Brimonidine Tartrate launch?
Brimonidine Tartrate is a drug marketed by Padagis Israel, Alembic, Apotex, Bausch And Lomb, Dr Reddys Labs Sa, Indoco, Lupin Ltd, Micro Labs, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Upsher Smith Labs, Florida, Glenmark Pharms Ltd, Sentiss, and Somerset. and is included in twenty-six NDAs.
The generic ingredient in BRIMONIDINE TARTRATE is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Brimonidine Tartrate
A generic version of BRIMONIDINE TARTRATE was approved as brimonidine tartrate; timolol maleate by SANDOZ on April 4th, 2022.
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Summary for BRIMONIDINE TARTRATE
| US Patents: | 0 |
| Applicants: | 17 |
| NDAs: | 26 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 153 |
| Clinical Trials: | 54 |
| Patent Applications: | 1,657 |
| Drug Prices: | Drug price information for BRIMONIDINE TARTRATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BRIMONIDINE TARTRATE |
| What excipients (inactive ingredients) are in BRIMONIDINE TARTRATE? | BRIMONIDINE TARTRATE excipients list |
| DailyMed Link: | BRIMONIDINE TARTRATE at DailyMed |
See drug prices for BRIMONIDINE TARTRATE
Recent Clinical Trials for BRIMONIDINE TARTRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Tulane University | Phase 4 |
| Visus Therapeutics | Phase 3 |
| Optall Vision | Phase 1 |
Pharmacology for BRIMONIDINE TARTRATE
| Drug Class | alpha-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists |
Medical Subject Heading (MeSH) Categories for BRIMONIDINE TARTRATE
Anatomical Therapeutic Chemical (ATC) Classes for BRIMONIDINE TARTRATE
Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Padagis Israel | BRIMONIDINE TARTRATE | brimonidine tartrate | GEL;TOPICAL | 209158-001 | Sep 23, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Upsher Smith Labs | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 216772-001 | Jun 12, 2024 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sentiss | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 091086-001 | Oct 31, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys Labs Sa | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 216361-001 | Feb 16, 2024 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 078480-001 | Dec 21, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 203172-001 | Mar 4, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
