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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
McKesson
Cerilliant
Moodys
Express Scripts
US Army
Queensland Health
Dow

Generated: April 21, 2018

DrugPatentWatch Database Preview

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 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
➤ 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
Merz Pharms CUVPOSA glycopyrrolate SOLUTION;ORAL 022571-001 Jul 28, 2010 RX Yes 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
Casper Pharma Llc ROBINUL FORTE glycopyrrolate TABLET;ORAL 012827-002 Approved Prior to Jan 1, 1982 AA RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sunovion Resp LONHALA MAGNAIR KIT glycopyrrolate SOLUTION;INHALATION 208437-001 Dec 5, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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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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 ➤ Try a Free Trial
7,541,022 Pharmaceutical formulations for dry powder inhalers ➤ Try a Free Trial
7,744,855 Method of making particles for use in a pharmaceutical composition ➤ Try a Free Trial
6,884,794 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets ➤ Try a Free Trial
Patent No. Title Estimated Patent 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
2013 00015 Denmark ➤ Try a Free Trial PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, HERUNDER GLYCOPYRRONIUMBROMID; REG. NO/DATE: EU/1/12/788/001-006 20121003
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
2013 00015 Denmark ➤ Try a Free Trial
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Accenture
Covington
Federal Trade Commission
Dow
Cerilliant
Queensland Health
AstraZeneca

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