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, Micro Labs, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Florida, Sentiss, and Upsher Smith Labs. and is included in twenty-one NDAs.
The generic ingredient in BRIMONIDINE TARTRATE is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Twelve 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.
Summary for BRIMONIDINE TARTRATE
| US Patents: | 0 |
| Applicants: | 14 |
| NDAs: | 21 |
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Florida | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 201949-001 | Oct 4, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Dr Reddys Labs Sa | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 216361-001 | Feb 16, 2024 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apotex | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 078480-001 | Dec 21, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sandoz | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 076254-001 | Sep 16, 2003 | AT | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sentiss | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 091086-001 | Oct 31, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Indoco | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 091691-001 | Nov 18, 2014 | AT | RX | No | No | ⤷ 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 |
