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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Federal Trade Commission
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Boehringer Ingelheim

Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204708

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NDA 204708 describes MIRVASO, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MIRVASO profile page.

The generic ingredient in MIRVASO is brimonidine tartrate. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.

Summary for NDA: 204708

Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 204708

Mechanism of ActionAdrenergic alpha-Agonists

Suppliers and Packaging for NDA: 204708

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
brimonidine tartrate
GEL;TOPICAL 204708 NDA Galderma Laboratories, L.P. 0299-5980 0299-5980-00 1 TUBE in 1 BLISTER PACK (0299-5980-00) > 2 g in 1 TUBE
brimonidine tartrate
GEL;TOPICAL 204708 NDA Galderma Laboratories, L.P. 0299-5980 0299-5980-02 2 g in 1 TUBE (0299-5980-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrengthEQ 0.33% BASE
Approval Date:Aug 23, 2013TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jun 13, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:May 24, 2025Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Aug 23, 2016
Regulatory Exclusivity Use:NEW DOSAGE FORM

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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Queensland Health
US Army

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