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 freedom to operate?
Brimonidine tartrate; timolol maleate
is the generic ingredient in two branded drugs marketed by Sandoz Inc and Allergan, and is included in two NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Brimonidine tartrate; timolol maleate has twenty-nine patent family members in nineteen countries.
Three suppliers are listed for this compound.
Summary for brimonidine tartrate; timolol maleate
International Patents: | 29 |
US Patents: | 11 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 3 |
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
Pharmacology for brimonidine tartrate; timolol maleate
Drug Class | alpha-Adrenergic Agonist beta-Adrenergic Blocker |
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Antagonists |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | |
>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 |
---|---|---|---|---|---|---|---|
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | See Plans and Pricing | See Plans and Pricing |
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | See Plans and Pricing | See Plans and Pricing |
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | See Plans and Pricing | See Plans and Pricing |
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for brimonidine tartrate; timolol maleate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 528945 | Combination of brimonidine and timolol for topical ophthalmic use for the treatment of glaucoma and intraocular pressure | See Plans and Pricing |
Spain | 2399045 | See Plans and Pricing | |
Norway | 326579 | See Plans and Pricing | |
Canada | 2440764 | COMBINAISON DE BRIMONIDINE ET DE TIMOLOL POUR UTILISATION TOPIQUE OPHTALMIQUE (COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for brimonidine tartrate; timolol maleate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1631293 | 300683 | Netherlands | See Plans and Pricing | PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225 |
1631293 | 14C0056 | France | See Plans and Pricing | PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225 |
1631293 | C300683 | Netherlands | See Plans and Pricing | PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225 |
1631293 | 2014C/042 | Belgium | See Plans and Pricing | PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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