Details for New Drug Application (NDA): 204251

✉ Email this page to a colleague

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^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 9,421,265 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:	9,044,484	Patent Expiration:	Oct 30, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	9,421,265	Patent Expiration:	Jun 17, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 204251

Subscribe to access the full database, or Subscribe
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	6,316,441	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.