Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204251

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NDA 204251 describes SIMBRINZA, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the SIMBRINZA profile page.

The generic ingredient in SIMBRINZA is brimonidine tartrate; brinzolamide. 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; brinzolamide profile page.
Summary for 204251
Tradename:SIMBRINZA
Applicant:Novartis
Ingredient:brimonidine tartrate; brinzolamide
Patents:3
Pharmacology for NDA: 204251
Suppliers and Packaging for NDA: 204251
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIMBRINZA brimonidine tartrate; brinzolamide SUSPENSION/DROPS;OPHTHALMIC 204251 NDA Alcon Laboratories, Inc. 0065-4147 0065-4147-25 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) > 2.5 mL in 1 BOTTLE, DROPPER
SIMBRINZA brimonidine tartrate; brinzolamide SUSPENSION/DROPS;OPHTHALMIC 204251 NDA Alcon Laboratories, Inc. 0065-4147 0065-4147-27 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-27) > 8 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.2%;1%
Approval Date:Apr 19, 2013TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Dec 7, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Patent:  Start TrialPatent Expiration:Oct 30, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 17, 2030Product Flag?YSubstance Flag?Delist Request?

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