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Serving 500+ biopharmaceutical companies globally:

Cipla
Dow
Merck
Queensland Health
Farmers Insurance
Accenture
Covington
QuintilesIMS
Daiichi Sankyo
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Generated: June 23, 2017

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 fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for NDA: 022571

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022571

Mechanism of ActionCholinergic Antagonists

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/5ML
Approval Date:Jul 28, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 28, 2017
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:7,638,552Patent 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:7,816,396Patent 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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Serving 500+ biopharmaceutical companies globally:

US Army
Covington
Express Scripts
Cantor Fitzgerald
QuintilesIMS
Mallinckrodt
Merck
Queensland Health
Fish and Richardson
Healthtrust

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.

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