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Last Updated: January 21, 2021

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 patent protection?

Glycopyrrolate is the generic ingredient in eight branded drugs marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal, Apotex, Aurobindo Pharma Ltd, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Piramal Critical, Prinston Inc, Riconpharma Llc, Sandoz Inc, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Hikma, Robins Ah, Novartis, Sunovion Resp, Exela Pharma, Merz Pharms, Alembic Labs, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Kenton, Leading Pharma Llc, Lgm Pharma, Natco Pharma Ltd, Oxford Pharms, Par Pharm, Renata, Rising, Sun Pharm Inds Ltd, and Casper Pharma Llc, and is included in forty-six NDAs. There are thirty-two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Glycopyrrolate has four hundred and fifteen patent family members in forty-one countries.

There are seventeen drug master file entries for glycopyrrolate. There is one tentative approval for this compound.

Drug Prices for glycopyrrolate

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Recent Clinical Trials for glycopyrrolate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Temple UniversityPhase 4
Tanta UniversityPhase 1
Rajesh DesharN/A

See all glycopyrrolate clinical trials

Generic filers with tentative approvals for GLYCOPYRROLATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1MG/5MLSOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for glycopyrrolate
Paragraph IV (Patent) Challenges for GLYCOPYRROLATE
Tradename Dosage Ingredient NDA Submissiondate
CUVPOSA SOLUTION;ORAL glycopyrrolate 022571 2012-06-20
ROBINUL FORTE TABLET;ORAL glycopyrrolate 012827 2010-10-12
ROBINUL TABLET;ORAL glycopyrrolate 012827 2010-10-12
ROBINUL TABLET;ORAL glycopyrrolate 012827 2009-08-14
ROBINUL FORTE TABLET;ORAL glycopyrrolate 012827 2009-08-14

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
Watson Labs GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 086947-001 Jun 24, 1983 DISCN No No   Start Trial   Start Trial   Start Trial
Casper Pharma Llc ROBINUL FORTE glycopyrrolate TABLET;ORAL 012827-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Watson Labs GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 086178-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for glycopyrrolate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015   Start Trial   Start Trial
Sunovion Resp LONHALA MAGNAIR KIT glycopyrrolate SOLUTION;INHALATION 208437-001 Dec 5, 2017   Start Trial   Start Trial
Novartis SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for glycopyrrolate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1267866 SPC/GB13/020 United Kingdom   Start Trial PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTERED: UK EU/1/12/788/001 20120928; UK EU/1/12/788/002 20120928; UK EU/1/12/788/003 20120928; UK EU/1/12/788/004 20120928; UK EU/1/12/788/005 20120928; UK EU/1/12/788/006 20120928
1267866 122013000029 Germany   Start Trial PRODUCT NAME: GLYKOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866 132013902141564 Italy   Start Trial PRODUCT NAME: GLICOPIRRONIO BROMURO(SEEBRI BREEZHALER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/788/001-006, 20120928
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Johnson and Johnson
Boehringer Ingelheim
Express Scripts
Dow

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 verification 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.