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Serving leading biopharmaceutical companies globally:

Teva
Fuji
Accenture
Colorcon
Healthtrust
Harvard Business School
UBS
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Dow
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Generated: October 18, 2017

DrugPatentWatch Database Preview

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 two suppliers. There are eight 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. Two suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

Summary for NDA: 021398

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:8
Formulation / Manufacturing:see details

Pharmacology for NDA: 021398

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.2%;EQ 0.5% BASE
Approval Date:Oct 30, 2007TE:RLD:Yes
Patent:► SubscribePatent Expiration:Apr 19, 2022Product 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:► SubscribePatent Expiration:Apr 19, 2022Product 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:► SubscribePatent Expiration:Jan 19, 2023Product Flag?YSubstance Flag?Delist Request?Y


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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Chinese Patent Office
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