Details for New Drug Application (NDA): 204251

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NDA 204251 describes SIMBRINZA, which is a drug marketed by Alcon Labs Inc and is included in one NDA. It is available from one supplier. There are two 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:	Alcon Labs Inc
Ingredient:	brimonidine tartrate; brinzolamide
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 204251

Generic Entry Date for 204251^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: SUSPENSION/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: 204251

Mechanism of Action	Adrenergic alpha-Agonists Carbonic Anhydrase Inhibitors

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:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.2%;1%
Approval Date:	Apr 19, 2013	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 30, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jun 17, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 204251

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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