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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022571

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NDA 022571 describes CUVPOSA, which is a drug marketed by Merz Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CUVPOSA profile page.

The generic ingredient in CUVPOSA is glycopyrrolate. There are seventeen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 022571
Tradename:CUVPOSA
Applicant:Merz Pharms
Ingredient:glycopyrrolate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022571
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 022571
Suppliers and Packaging for NDA: 022571
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CUVPOSA glycopyrrolate SOLUTION;ORAL 022571 NDA Merz Pharmaceuticals, LLC 0259-0501 0259-0501-16 1 BOTTLE in 1 CARTON (0259-0501-16) > 473 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 022571
Tradename Dosage Ingredient NDA Submissiondate
CUVPOSA SOLUTION;ORAL glycopyrrolate 022571 2012-06-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/5ML
Approval Date:Jul 28, 2010TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 20, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCE CHRONIC SEVERE DROOLING (I.E., SIALORRHEA)IN PATIENTS WITH NEUROLOGIC CONDITIONS ASSOCIATED WITH PROBLEM DROOLING
Patent:  Start TrialPatent Expiration:Aug 20, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCE CHRONIC SEVERE DROOLING (I.E., SIALORRHEA)IN PATIENTS WITH NEUROLOGIC CONDITIONS ASSOCIATED WITH PROBLEM DROOLING

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