DrugPatentWatch Database Preview
Glycopyrrolate - Generic Drug Details
What are the generic sources for glycopyrrolate and what is the scope of patent protection?
Glycopyrrolate
is the generic ingredient in eight branded drugs marketed by Abraxis Pharm, Am Regent, Amneal, Apotex, Aurobindo Pharma Ltd, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Piramal Critical, Prinston Inc, Sandoz Inc, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Hikma, Robins Ah, Sunovion Pharms Inc, Sunovion Resp, Exela Pharma Scs Llc, Merz Pharms, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Kenton, Leading Pharma Llc, Natco Pharma Ltd, Nexgen Pharma, Orit Labs Llc, Oxford Pharms, Par Pharm, Renata, Rising, Sun Pharm Inds Ltd, and Casper Pharma Llc, and is included in forty-four NDAs. There are thirty 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 ninety-eight patent family members in forty countries.
There are seventeen drug master file entries for glycopyrrolate. Forty-four suppliers are listed for this compound.
Summary for glycopyrrolate
| International Patents: | 398 |
| US Patents: | 30 |
| Tradenames: | 8 |
| Applicants: | 37 |
| NDAs: | 44 |
| Drug Master File Entries: | 17 |
| Suppliers / Packagers: | 44 |
| Bulk Api Vendors: | 76 |
| Clinical Trials: | 122 |
| Patent Applications: | 4,170 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for glycopyrrolate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for glycopyrrolate |
| DailyMed Link: | glycopyrrolate at DailyMed |
Recent Clinical Trials for glycopyrrolate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Taipei Veterans General Hospital, Taiwan | N/A |
| Sunovion Respiratory Development Inc. | Phase 4 |
| University of South Florida | Phase 3 |
Recent Litigation for glycopyrrolate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Vectura Limited v. GlaxoSmithKline LLC | 2016-07-27 |
| Merz Pharmaceuticals LLC v. Par Pharmaceutical Inc. | 2012-12-17 |
Pharmacology for glycopyrrolate
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for glycopyrrolate
Synonyms for glycopyrrolate
| .beta.-1-Methyl-3-pyrrolidyl-.alpha.-cyclopentylmandelate methobromide |
| (1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenyl-acetate bromide |
| (1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenylacetate bromide |
| [(3S)-1,1-dimethylpyrrolidin-1-ium-3-yl] (2R)-2-cyclopentyl-2-hydroxy-2-phenylacetate;bromide |
| 1-Methyl-3-pyrrolidinyl .alpha.-phenylcyclopentaneglycolate methobromide |
| 1-methyl-3-pyrrolidyl alpha-cyclopentylmandelate methobromide |
| 1-methyl-3-pyrrolidyl alpha-phenyl-alpha-cyclopentylglycolate methobromide |
| 1-Methyl-3-pyrrolidyl alpha-phenylcyclopentaneglycolate methobromide |
| 1,1-Dimethyl-3-hydroxypyrrolidinium bromide .alpha.-cyclopentylmandelate |
| 1,1-Dimethyl-3-hydroxypyrrolidinium bromide alpha-cyclopentylmandelate |
| 3-(2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide |
| 3-(2-Cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidinium Bromide |
| 3-(2-phenyl-2-cyclopentylglycoloyloxy)-1,1-dimethylpyrrolidinium bromide |
| 3-(erythro-2-Cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidiniumbromid |
| 3-{[cyclopentyl(hydroxy)phenylacetyl]oxy}-1,1-dimethylpyrrolidin-1-ium bromide |
| 3-Hydroxy-1,1-dimethylpyrrolidinium bromide .alpha.-cyclopentylmandelate |
| 3-Hydroxy-1,1-dimethylpyrrolidinium bromide alpha-cyclopentylmandelate |
| 3-Hydroxy-1,1-dimethylpyrrolidinium bromide-.alpha.-cyclopentylmandelate |
| 475468-09-8 |
| 51186-83-5 |
| 53808-86-9 |
| 596-51-0 |
| AB0010706 |
| AC-23382 |
| AC1L1XX0 |
| AC1LAW54 |
| AC1Q1RGS |
| AD-237 |
| AHR 504 |
| AHR-504 |
| AKOS015962136 |
| alpha-cyclopentylmandelic acid ester with 3-hydroxy-1,1-dimethylpyrrolidinium bromide |
| AN-46262 |
| Asecryl |
| BC209826 |
| BCP07110 |
| Bromure de glycopyrronium |
| Bromure de glycopyrronium [INN-French] |
| Bromure de ritropirronio |
| Bromure de ritropirronium |
| Bromuro de glicopirronio |
| Bromuro de glicopirronio [INN-Spanish] |
| C19H28BrNO3 |
| C19H28NO3 |
| CAS-596-51-0 |
| CCG-101030 |
| CCG-213543 |
| CHEBI:90972 |
| CHEMBL1201027 |
| CHF-5992 |
| Copyrrolate |
| CPD000469282 |
| CS-1763 |
| Cuvposa |
| Cuvposa (TN) |
| D00540 |
| DSSTox_CID_3109 |
| DSSTox_GSID_23109 |
| DSSTox_RID_76878 |
| DTXSID6023109 |
| EINECS 209-887-0 |
| erythro-3-Hydroxy-1,1-dimethylpyrrolidinium bromide alpha-cyclopentylmandelate |
| erythro-3-Hydroxy-1,1-dimethylpyrrolidinium bromide alpha-cyclopentylmandelate. |
| FT-0626787 |
| G0392 |
| Gastrodyn |
| Glycopyrrolate (USP) |
| Glycopyrrolate [USAN:USP] |
| Glycopyrrolate [USAN] |
| Glycopyrrolate bromide |
| Glycopyrrolate, >=98% (HPLC) |
| Glycopyrrolate, United States Pharmacopeia (USP) Reference Standard |
| GLYCOPYRRONE BROMIDE |
| Glycopyrroni bromidum |
| Glycopyrronii bromidum |
| Glycopyrronii bromidum [INN-Latin] |
| Glycopyrronium |
| glycopyrronium bromide |
| Glycopyrronium Bromide ,(S) |
| Glycopyrronium bromide (JAN/INN) |
| Glycopyrronium bromide, European Pharmacopoeia (EP) Reference Standard |
| Glycopyrronium for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Glycopyrronium impurity N, European Pharmacopoeia (EP) Reference Standard |
| HMS1570E14 |
| HMS2051P12 |
| HMS2094A05 |
| HMS2097E14 |
| HMS2235F12 |
| HMS3259P04 |
| HMS3369F10 |
| HMS3393P12 |
| HMS3714E14 |
| HY-17465 |
| I14-3643 |
| Lonhala Magnair |
| LS-138344 |
| Mandelic acid, ester with 3-hydroxy-1,1-dimethylpyrrolidinium bromide |
| MFCD00072137 |
| MLS001424112 |
| MLS002222301 |
| MolPort-006-112-011 |
| NC00280 |
| NC00694 |
| NCGC00179456-02 |
| NCGC00179456-04 |
| Nodapton |
| Nodapton|||Robanul|||Robinul|||Tarodyl|||Tarodyn |
| NSC 250836 |
| NSC 251251 |
| NSC 251252 |
| NSC-250836 |
| NSC-251251 |
| NSC-251252 |
| NSC-759238 |
| NSC250836 |
| NSC251251 |
| NSC251252 |
| NSC759238 |
| NVA 237 |
| NVA-237 |
| OR315526 |
| Pharmakon1600-01505753 |
| PT-001 |
| Pyrrolidinium, 1,1-dimethyl-3-hydroxy-, bromide, alpha-cyclopentylmandelate |
| Pyrrolidinium, 3-((cyclopentylhydroxyphenylacetyl)oxy)-1,1-dimethyl-, bromide |
| Pyrrolidinium, 3-hydroxy-1,1-dimethyl-, bromide, alpha-cyclopentylmandelate |
| Pyrrolidinium, 3-hydroxy-1,1-dimethyl-, bromide, alpha-cyclopentylmandelate (8CI) |
| Pyrrolidinium,1-dimethyl-, bromide |
| Pyrrolidinium,1-dimethyl-, bromide, .alpha.-cyclopentylmandelate |
| Ritropirronium bromide |
| Ritropirronium bromide [INN] |
| RL04249 |
| Robanul |
| Robinal |
| Robinul |
| Robinul (TN) |
| ROBINUL FORTE |
| s4660 |
| SAM001246629 |
| SAM002589987 |
| SCHEMBL41436 |
| Seebri |
| Seebri Breezhaler |
| Seebri breezhaler (TN) |
| Seebri Neohaler |
| SMR000469282 |
| SR-01000763650 |
| SR-01000763650-3 |
| ST24047338 |
| Tarodyl |
| Tarodyn |
| Tox21_113144 |
| Tox21_113144_1 |
| Tox21_113145 |
| VPNYRYCIDCJBOM-UHFFFAOYSA-M |
| WLN: T5KTJ A1 A1 COVXQR&- AL5TJ &Q &E |
Paragraph IV (Patent) Challenges for GLYCOPYRROLATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CUVPOSA | SOLUTION;ORAL | glycopyrrolate | 022571 | 2012-06-20 |
| ROBINUL | TABLET;ORAL | glycopyrrolate | 012827 | 2010-10-12 |
| ROBINUL FORTE | TABLET;ORAL | glycopyrrolate | 012827 | 2010-10-12 |
| ROBINUL FORTE | TABLET;ORAL | glycopyrrolate | 012827 | 2009-08-14 |
| ROBINUL | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurolife Pharma Llc | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 202675-001 | Apr 15, 2013 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Prinston Inc | GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 210927-001 | Oct 31, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Rising | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 040821-002 | Dec 29, 2008 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Kenton | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 091182-002 | Feb 3, 2014 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Kenton | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 091182-001 | Feb 3, 2014 | AA | RX | 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 |
|---|---|---|---|---|---|---|---|
| Sunovion Pharms Inc | SEEBRI | glycopyrrolate | POWDER;INHALATION | 207923-001 | Oct 29, 2015 | Start Trial | Start Trial |
| Sunovion Pharms Inc | SEEBRI | glycopyrrolate | POWDER;INHALATION | 207923-001 | Oct 29, 2015 | Start Trial | Start Trial |
| Sunovion Pharms Inc | 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 |
International Patents for glycopyrrolate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2368482 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0243701 | Start Trial |
| Australia | 2085702 | Start Trial |
| China | 1802157 | Start Trial |
| European Patent Office | 1296651 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for glycopyrrolate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1267866 | 122014000025 | Germany | Start Trial | 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 | 92393 | Luxembourg | Start Trial | PRODUCT 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 |
| 1267866 | 2013C/023 | Belgium | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), AUTRE, ADRESSE (NO SUPPRIME) |
| 1267866 | CA 2013 00015 | Denmark | Start Trial | |
| 1267866 | 2013/014 | Ireland | Start Trial | PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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