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Serving leading biopharmaceutical companies globally:

Covington
Cantor Fitzgerald
Baxter
Accenture
Boehringer Ingelheim
Teva
Chubb
Mallinckrodt
Cerilliant
Colorcon

Generated: November 19, 2017

DrugPatentWatch Database Preview

GLYCOPYRROLATE - Generic Drug Details

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

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, Somerset Theraps Llc, Sun Pharm Inds Ltd, Dr Reddys Labs Ltd, Par Pharm, West-ward Pharms Int, Hikma Farmaceutica, Robins Ah, Epic Pharma Llc, Teva Parenteral, Merz Pharms, Amneal Pharms Co, Abraxis Pharm, Aurolife Pharma Llc, Santos Biotech, Hospira, and Leading Pharma Llc, and is included in thirty-two 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 eleven patent family members in forty countries and fifteen supplementary protection certificates in seven countries.

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

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
u► Subscribe1MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Santos Biotech
GLYCOPYRROLATE
glycopyrrolate
TABLET;ORAL091182-001Feb 3, 2014AARXNoNo► Subscribe► Subscribe► Subscribe
Sunovion Pharms Inc
SEEBRI
glycopyrrolate
POWDER;INHALATION207923-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Santos Biotech
GLYCOPYRROLATE
glycopyrrolate
TABLET;ORAL091182-002Feb 3, 2014AARXNoNo► Subscribe► Subscribe► Subscribe
Sunovion Pharms Inc
SEEBRI
glycopyrrolate
POWDER;INHALATION207923-001Oct 29, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Watson Labs
GLYCOPYRROLATE
glycopyrrolate
TABLET;ORAL086902-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Epic Pharma Llc
GLYCOPYRROLATE
glycopyrrolate
TABLET;ORAL040568-002Dec 22, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Teva Parenteral
GLYCOPYRROLATE
glycopyrrolate
INJECTABLE;INJECTION081169-001Sep 10, 1991DISCNNoNo► Subscribe► Subscribe► 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, 2015► Subscribe► 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
8,182,791Formulations for use in inhaler devices► Subscribe
6,884,794 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets► Subscribe
7,541,022Pharmaceutical formulations for dry powder inhalers► Subscribe
9,351,928Method of making particles for use in a pharmaceutical composition► Subscribe
9,585,839Particles for use in a pharmaceutical composition► Subscribe
8,101,160Formulations for use in inhaler devices► Subscribe
7,368,104Treatment of respiratory diseases► Subscribe
8,871,274Pharmaceutical formulations for dry powder inhalers► Subscribe
7,091,236Method for increasing the bioavailability of glycopyrrolate► Subscribe
7,223,748Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets► 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
Poland364024► Subscribe
Luxembourg92166► Subscribe
European Patent Office1613323► Subscribe
China101181263► Subscribe
European Patent Office1276473► Subscribe
European Patent Office1663180► Subscribe
Estonia200200593► Subscribe
Portugal1274406► Subscribe
Australia2211802► Subscribe
Portugal1920763► 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
2013000029Germany► SubscribePRODUCT NAME: GLYKOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
00651Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN; REGISTRATION NO/DATE: EU/1/13/862/001-006 20130919
2013 00015Denmark► Subscribe
393Luxembourg► SubscribePRODUCT NAME: GLYCOPYRRONIUM OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL BROMURE, COMBINE A INDACATEROL OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL MALEATE. FIRST REGISTRATION: 20130923
13/014Ireland► SubscribePRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
0583Netherlands► SubscribePRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE AFGELEIDEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866/01Switzerland► SubscribeFORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
1267866/02Switzerland► SubscribeFORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
2014000025Germany► SubscribePRODUCT 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
166Luxembourg► SubscribePRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Moodys
Julphar
Express Scripts
Covington
Johnson and Johnson
Cerilliant
Dow
Baxter
Medtronic

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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