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Generated: August 22, 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 Pharms Corp 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
Applicant:Novartis Pharms Corp
Ingredient:brimonidine tartrate; brinzolamide
Generic Entry Opportunity Date for 204251
Generic Entry Date for 204251*:
Constraining patent/regulatory exclusivity:

*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
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:➤ Sign UpPatent Expiration:Dec 7, 2019Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Oct 30, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jun 17, 2030Product Flag?YSubstance Flag?Delist Request?

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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 verifification 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.