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Details for Generic Name: brimonidine tartrate

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Brimonidine tartrate is the generic ingredient in seven branded drugs marketed by Galderma Labs Lp, Allergan, Akorn, Alcon Pharms Ltd, Bausch And Lomb, Indoco Remedies, Sandoz, Teva Parenteral, and Alcon Res Ltd, and is included in fourteen NDAs. There are twenty-three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for brimonidine tartrate. Five suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: brimonidine tartrate

Tradenames:7
Patents:23
Applicants:9
NDAs:14
Drug Master File Entries: see list11
Suppliers: see list5
Therapeutic Class:Ophthalmic Agents

Pharmacology for Ingredient: brimonidine tartrate

Tentative approvals for BRIMONIDINE TARTRATE

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION; OPHTHALMIC0.1%
<disabled><disabled>SOLUTION; OPHTHALMIC0.2%; 0.5%
<disabled><disabled>SOLUTION; OPHTHALMIC0.2%; 0.5%

Clinical Trials for: brimonidine tartrate

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001RXYes6,562,873*PED<disabled>Y<disabled>
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021770-001Aug 19, 2005RXYes6,673,337*PED<disabled>Y<disabled>
Allergan
COMBIGAN
brimonidine tartrate; timolol maleate
SOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYes8,354,409<disabled>Y<disabled>
Teva Parenteral
BRIMONIDINE TARTRATE
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC076372-001Sep 10, 2004DISCNNo<disabled><disabled>
Galderma Labs Lp
MIRVASO
brimonidine tartrate
GEL;TOPICAL204708-001Aug 23, 2013RXYes8,426,410<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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