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Glycopyrrolate - Generic Drug Details

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Glycopyrrolate 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, Novartis Pharms Corp, 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 twenty patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and thirty-five patent family members in forty-four countries.

There are fourteen drug master file entries for glycopyrrolate. Twenty-eight suppliers are listed for this compound.

Summary for Generic Name: glycopyrrolate

Tradenames:6
Patents:20
Applicants:24
NDAs:30
Drug Master File Entries: see list14
Suppliers / Packagers: see list28
Bulk Api Vendors: see list50
Clinical Trials: see list40
Patent Applications: see list1,980
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: glycopyrrolate

Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Casper Pharma Llc
ROBINUL
glycopyrrolate
TABLET;ORAL012827-001Approved Prior to Jan 1, 1982RXYes► subscribe► subscribe
Hikma Farmaceutica
GLYCOPYRROLATE
glycopyrrolate
INJECTABLE;INJECTION090963-001Sep 21, 2011RXYes► subscribe► subscribe
Novartis Pharms Corp
SEEBRI
glycopyrrolate
POWDER;INHALATION207923-001Oct 29, 2015RXYes8,479,730► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: glycopyrrolate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
SEEBRI
glycopyrrolate
POWDER;INHALATION207923-001Oct 29, 20156,521,260► subscribe
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Non-Orange Book Patents for Generic Ingredient: glycopyrrolate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,011,818Carrier particles for use in dry powder inhalers► subscribe
6,221,338 Method of producing particles for use in dry powder inhalers► subscribe
7,368,104Treatment of respiratory diseases► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: glycopyrrolate

Country Document Number Estimated Expiration
Spain2375007► subscribe
Denmark1663155► subscribe
Hungary1300117► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: GLYCOPYRROLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00015Denmark► subscribePRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, HERUNDER GLYCOPYRRONIUMBROMID; REG. NO/DATE: EU/1/12/788/001-006 20121003
166Luxembourg► subscribePRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS
13/014Ireland► subscribePRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
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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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