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Generated: October 20, 2018

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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 eight 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, Sunovion Pharms Inc, Sunovion Resp, Exela Pharma Scs Llc, West-ward Pharms Int, Merz Pharms, Anda Repository, Appco Pharma Llc, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Hikma Intl Pharms, Leading Pharma Llc, Natco Pharma Ltd, Nexgen Pharma, Oxford Pharms, Par Pharm, Renata, Santos Biotech, Sun Pharm Inds Ltd, and Casper Pharma Llc, and is included in thirty-five NDAs. There are twenty-nine patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for glycopyrrolate. Forty 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
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
53808-86-9
596-51-0
AB0010706
AC-23382
AC1L1XX0
AC1LAW54
AC1Q1RGS
AD-237
AHR 504
AHR-504
AK163383
AKOS015962136
alpha-cyclopentylmandelic acid ester with 3-hydroxy-1,1-dimethylpyrrolidinium bromide
AN-46262
Asecryl
BC209826
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
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 (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
glycopyrroniumbromide
HE066676
HE344621
HE350010
HE357924
HMS1570E14
HMS2051P12
HMS2094A05
HMS2097E14
HMS2235F12
HMS3259P04
HMS3369F10
HMS3393P12
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
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
Robinal
Robinul
Robinul (TN)
ROBINUL FORTE
s4660
SAM001246629
SAM002589987
SCHEMBL41436
Seebri
Seebri Breezhaler
Seebri breezhaler (TN)
Seebri Neohaler
SMR000469282
ST24047338
ST51054976
Tarodyl
Tarodyn
Tox21_113144
Tox21_113144_1
Tox21_113145
VPNYRYCIDCJBOM-UHFFFAOYSA-M
WLN: T5KTJ A1 A1 COVXQR&- AL5TJ &Q &E
Tentative approvals for GLYCOPYRROLATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial1MGTABLET;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 SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Natco Pharma Ltd GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 091413-001 Jun 20, 2016 AA RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Anda Repository GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040821-002 Dec 29, 2008 AA RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Par Pharm GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040653-001 Aug 31, 2006 AA RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sunovion Pharms Inc SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Somerset Theraps Llc GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 207639-001 Jun 23, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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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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 ➤ Try a Free Trial ➤ Try a Free Trial
Sunovion Pharms Inc SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Sunovion Pharms Inc SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for GLYCOPYRROLATE

Country Document Number Estimated Expiration
European Patent Office 1276472 ➤ Try a Free Trial
Norway 20054767 ➤ Try a Free Trial
Russian Federation 2363501 ➤ Try a Free Trial
Japan 4589862 ➤ Try a Free Trial
Denmark 1296651 ➤ Try a Free Trial
Spain 2434845 ➤ Try a Free Trial
Singapore 169233 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for GLYCOPYRROLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
9 Finland ➤ Try a Free Trial
2013000029 Germany ➤ Try a Free Trial PRODUCT NAME: GLYKOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866/01 Switzerland ➤ Try a Free Trial FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
13/014 Ireland ➤ Try a Free Trial PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
00583 Netherlands ➤ Try a Free Trial PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
00651 Netherlands ➤ Try a Free Trial PRODUCT NAME: COMBINATIE VAN; REGISTRATION NO/DATE: EU/1/13/862/001-006 20130919
0583 Netherlands ➤ Try a Free Trial PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE AFGELEIDEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Julphar
Express Scripts
McKesson
Dow
AstraZeneca
Chubb
Covington
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.