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Last Updated: March 28, 2024

Brimonidine tartrate; timolol maleate - Generic Drug Details


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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, Sandoz, Sentiss, Upsher Smith Labs, and Abbvie, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for brimonidine tartrate; timolol maleate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AllerganPhase 3
Allergan
AllerganPhase 4

See all brimonidine tartrate; timolol maleate clinical trials

Generic filers with tentative approvals for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial0.2%; 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.

Pharmacology 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
Upsher Smith Labs BRIMONIDINE TARTRATE AND TIMOLOL MALEATE brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 215598-001 Dec 12, 2022 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
Apotex BRIMONIDINE TARTRATE AND TIMOLOL MALEATE brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 091442-001 Apr 20, 2022 AB 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

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 ⤷  Try a Trial ⤷  Try a Trial
Abbvie COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 ⤷  Try a Trial ⤷  Try a Trial
Abbvie COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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