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Details for New Drug Application (NDA): 021398
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NDA 021398 describes COMBIGAN, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the COMBIGAN profile page.
The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
Summary for 021398
| Tradename: | COMBIGAN |
| Applicant: | Allergan |
| Ingredient: | brimonidine tartrate; timolol maleate |
| Patents: | 11 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 021398
Generic Entry Date for 021398*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION/DROPS;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 021398
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 021398
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398 | NDA | Allergan, Inc. | 0023-9211 | 0023-9211-03 | 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-03) > 2.5 mL in 1 BOTTLE, DROPPER |
| COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398 | NDA | Allergan, Inc. | 0023-9211 | 0023-9211-05 | 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-05) > 5 mL in 1 BOTTLE, DROPPER |
Paragraph IV (Patent) Challenges for 021398
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| COMBIGAN | SOLUTION/DROPS;OPHTHALMIC | brimonidine tartrate; timolol maleate | 021398 | 2008-11-21 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.2%;EQ 0.5% BASE | ||||
| Approval Date: | Oct 30, 2007 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Apr 19, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY CONTROLLED IOP. DOSE IS ONE DROP OF COMBIGAN IN THE AFFECTED EYE TWICE DAILY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Apr 19, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY CONTROLLED IOP. DOSE IS ONE DROP OF COMBIGAN IN THE AFFECTED EYE TWICE DAILY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jan 19, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | Y | |
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