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Generated: April 20, 2018

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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 seven 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, Sunovion Resp, 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-four NDAs. There are twenty-seven 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 eighty-three patent family members in forty countries.

There are seventeen drug master file entries for glycopyrrolate. Thirty-seven 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
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
➤ Sign Up➤ Sign Up1MGTABLET;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
West-ward Pharms Int ROBINUL glycopyrrolate INJECTABLE;INJECTION 017558-001 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vintage Pharms GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 090020-002 Oct 19, 2011 AA RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040847-001 Mar 21, 2008 AA RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 086178-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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
7,368,104 Treatment of respiratory diseases ➤ Sign Up
7,541,022 Pharmaceutical formulations for dry powder inhalers ➤ Sign Up
7,744,855 Method of making particles for use in a pharmaceutical composition ➤ Sign Up
6,884,794 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for GLYCOPYRROLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00015 Denmark ➤ Sign Up PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, HERUNDER GLYCOPYRRONIUMBROMID; REG. NO/DATE: EU/1/12/788/001-006 20121003
2014 00020 Denmark ➤ Sign Up 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
2013000029 Germany ➤ Sign Up PRODUCT NAME: GLYKOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
00583 Netherlands ➤ Sign Up PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; 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:

Baxter
AstraZeneca
Dow
Fuji
US Army
Covington
Colorcon
Daiichi Sankyo
Moodys

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