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Serving leading biopharmaceutical companies globally:

Cipla
Merck
Citi
US Department of Justice
Moodys
Teva
Covington
US Army
Harvard Business School
Cantor Fitzgerald

Generated: January 22, 2018

DrugPatentWatch Database Preview

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?

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

Glycopyrrolate has three hundred and sixteen patent family members in forty countries.

There are seventeen drug master file entries for glycopyrrolate. Thirty-five suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for glycopyrrolate
Pharmacology for glycopyrrolate
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for glycopyrrolate
Tentative approvals for GLYCOPYRROLATE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe1MGTABLET;ORAL

US Patents and Regulatory Information for glycopyrrolate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Casper Pharma Llc ROBINUL glycopyrrolate TABLET;ORAL 012827-001 Approved Prior to Jan 1, 1982 AA RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Merz Pharms CUVPOSA glycopyrrolate SOLUTION;ORAL 022571-001 Jul 28, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hikma Intl Pharms GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040836-002 Mar 5, 2009 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Epic Pharma Llc GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040568-001 Dec 22, 2004 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Leading Pharma Llc GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 090195-001 Sep 21, 2012 AA RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sunovion Pharms Inc SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
9,585,839 Particles for use in a pharmaceutical composition ➤ Subscribe
9,351,928 Method of making particles for use in a pharmaceutical composition ➤ Subscribe
6,884,794 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets ➤ Subscribe
8,182,791 Formulations for use in inhaler devices ➤ Subscribe
7,744,855 Method of making particles for use in a pharmaceutical composition ➤ Subscribe
8,932,635 Pharmaceutical compositions of hydrophobic surface-modified active substance microparticles for inhalation ➤ Subscribe
8,101,160 Formulations for use in inhaler devices ➤ Subscribe
7,223,748 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets ➤ Subscribe
7,368,104 Treatment of respiratory diseases ➤ Subscribe
7,541,022 Pharmaceutical formulations for dry powder inhalers ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for glycopyrrolate

Supplementary Protection Certificates for glycopyrrolate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
9 Finland ➤ Subscribe
13/014 Ireland ➤ Subscribe PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
2014 00020 Denmark ➤ Subscribe PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, ISAER BROMIDSALTET, I KOMBINATION MED INDACATEROL ELLER ET SALT DERAF, ISAER MALEATSALTET; REG. NO/DATE: EU/1/13/862 20130919
166 Luxembourg ➤ Subscribe PRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS
3 Finland ➤ Subscribe
0583 Netherlands ➤ Subscribe PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE AFGELEIDEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
00651 Netherlands ➤ Subscribe PRODUCT NAME: COMBINATIE VAN; REGISTRATION NO/DATE: EU/1/13/862/001-006 20130919
00583 Netherlands ➤ Subscribe PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
2014000025 Germany ➤ Subscribe PRODUCT NAME: GLYCOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON (KOMPONENTE 1) UND INDACATEROL ODER EIN DERIVAT HIERVON ODER EIN SALZ VON INDACATEROL ODER EINEM DERIVAT HIERVON (KOMPONENTE 2); REGISTRATION NO/DATE: EU/1/13/862 20130919
1267866/02 Switzerland ➤ Subscribe FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health
Baxter
UBS
Merck
Argus Health
Daiichi Sankyo
QuintilesIMS
Federal Trade Commission

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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