Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: August 25, 2019

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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 eight branded drugs marketed by Abraxis Pharm, Amneal Pharms Co, Aurobindo Pharma Ltd, Caplin, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Luitpold, Piramal Critical, Prinston Inc, Sandoz Inc, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Robins Ah, West-ward Pharms Int, 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-two 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.

Glycopyrrolate has three hundred and ninety-two patent family members in forty countries.

There are seventeen drug master file entries for glycopyrrolate. Fifty-one 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
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
Generic filers with tentative approvals for GLYCOPYRROLATE
Applicant Application No. Strength Dosage Form
  Try a Free Trial  Try a Free Trial1MGTABLET;ORAL

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

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
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 Y   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 Y   Try a Free Trial
Sun Pharm Inds Ltd GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040844-001 Aug 18, 2009 AA 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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Supplementary Protection Certificates for GLYCOPYRROLATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1267866 493 Finland   Try a Free Trial
1267866 92393 Luxembourg   Try a Free 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 C300583 Netherlands   Try a Free Trial PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866 C01267866/02 Switzerland   Try a Free Trial FORMER OWNER: SOSEI R&D LTD., GB
1267866 16/2013 Austria   Try a Free Trial PRODUCT NAME: GLYCOPYRRONIUM, GLYCOPYRRONIUMSALZ; 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.