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Generated: May 26, 2017

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Glycopyrrolate - Generic Drug Details

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What are the generic sources for glycopyrrolate and what is the scope of glycopyrrolate freedom to operate?

is the generic ingredient in six branded drugs marketed by Watson Labs, Appco Pharma Llc, Natco Pharma Ltd, Vintage Pharms, Rising Pharms Inc, Nexgen Pharma, Sunovion Pharms Inc, Casper Pharma Llc, Luitpold, Hikma Intl Pharms, Sun Pharm Inds Ltd, Dr Reddys Labs Ltd, Par Pharm, West-ward Pharms Int, Hikma Farmaceutica, Robins Ah, Corepharma, Teva Parenteral, Merz Pharms, Abraxis Pharm, Aurolife Pharma Llc, Stason Pharms, Hospira, and Leading Pharma Llc, and is included in thirty NDAs. There are nineteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Glycopyrrolate has two hundred and seventy-nine patent family members in thirty-eight countries.

There are fifteen drug master file entries for glycopyrrolate. Thirty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: glycopyrrolate

Drug Master File Entries: see list15
Suppliers / Packagers: see list31
Bulk Api Vendors: see list50
Clinical Trials: see list41
Patent Applications: see list3,355
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:glycopyrrolate at DailyMed

Pharmacology for Ingredient: glycopyrrolate

Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists

Tentative approvals for GLYCOPYRROLATE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe1MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Intl Pharms
TABLET;ORAL040836-002Mar 5, 2009DISCNNoNo► Subscribe► Subscribe
Sunovion Pharms Inc
POWDER;INHALATION207923-001Oct 29, 2015RXYesYes8,580,306► SubscribeY ► Subscribe
Hikma Intl Pharms
TABLET;ORAL040836-001Mar 5, 2009DISCNNoNo► Subscribe► Subscribe
Watson Labs
TABLET;ORAL086902-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Sunovion Pharms Inc
POWDER;INHALATION207923-001Oct 29, 2015RXYesYes8,048,451► SubscribeY ► Subscribe
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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.

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