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Glycopyrrolate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for glycopyrrolate?

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, 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 eighteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are fifteen drug master file entries for glycopyrrolate. Twenty-nine suppliers are listed for this compound.

Summary for Generic Name: glycopyrrolate

Tradenames:6
Patents:19
Applicants:24
NDAs:30
Drug Master File Entries: see list15
Suppliers / Packagers: see list29
Bulk Api Vendors: see list50
Clinical Trials: see list41
Patent Applications: see list1,980
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
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Farmaceutica
GLYCOPYRROLATE
glycopyrrolate
INJECTABLE;INJECTION090963-001Sep 21, 2011RXNoYes► Subscribe► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes8,303,991► SubscribeY ► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes8,029,768► Subscribe ► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes8,479,730► SubscribeY ► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes8,580,306► 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
Sunovion Pharms Inc
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
7,368,104Treatment of respiratory diseases► Subscribe
7,091,236Method for increasing the bioavailability of glycopyrrolate► Subscribe
8,101,160Formulations for use in inhaler devices► Subscribe
7,744,855Method of making particles for use in a pharmaceutical composition► Subscribe
9,566,239Pharmaceutical formulations for dry powder inhalers► 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
Canada2539041► Subscribe
World Intellectual Property Organization (WIPO)0178696► Subscribe
Australia2085702► Subscribe
China100569238► Subscribe
Australia2004242450► 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
1267866/01Switzerland► SubscribeFORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
2013 00015Denmark► Subscribe
13/014Ireland► SubscribePRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866/02Switzerland► SubscribeFORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
2013 00015Denmark► SubscribePRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, HERUNDER GLYCOPYRRONIUMBROMID; REG. NO/DATE: EU/1/12/788/001-006 20121003
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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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