BRIMONIDINE TARTRATE; TIMOLOL MALEATE - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for brimonidine tartrate; timolol maleate and what is the scope of patent protection?
Brimonidine tartrate; timolol maleate
is the generic ingredient in two branded drugs marketed by Alembic, Apotex, Florida, Glenmark Pharms Ltd, Sandoz, Sentiss, Somerset, Upsher Smith Labs, and Abbvie, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 14 |
| Clinical Trials: | 6 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
| DailyMed Link: | BRIMONIDINE TARTRATE; TIMOLOL MALEATE at DailyMed |
Recent Clinical Trials for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Allergan | Phase 3 |
| Allergan | |
| Allergan | Phase 4 |
See all BRIMONIDINE TARTRATE; TIMOLOL MALEATE clinical trials
Generic filers with tentative approvals for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
| Drug Class | alpha-Adrenergic Agonist beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| COMBIGAN | Ophthalmic Solution | brimonidine tartrate; timolol maleate | 0.2%/0.5% | 021398 | 1 | 2008-11-21 |
US Patents and Regulatory Information for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glenmark Pharms Ltd | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 214987-001 | May 16, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | AB | RX | Yes | Yes | ⤷ 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 | |||
| Apotex | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 091442-001 | Apr 20, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Florida | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 201949-001 | Oct 4, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alembic | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 215230-001 | Aug 25, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Somerset | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 216114-001 | Sep 10, 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 |
Expired US Patents for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
