Brimonidine tartrate; timolol maleate - Generic Drug Details

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What are the generic drug 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

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	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.

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	215598-001	Dec 12, 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
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
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

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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