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Last Updated: February 24, 2020

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ROBINUL Drug Profile


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Which patents cover Robinul, and when can generic versions of Robinul launch?

Robinul is a drug marketed by Hikma, Robins Ah, and Casper Pharma Llc. and is included in three NDAs.

The generic ingredient in ROBINUL is glycopyrrolate. There are seventeen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

US ANDA Litigation and Generic Entry Outlook for Robinul

A generic version of ROBINUL was approved as glycopyrrolate by AM REGENT on July 23rd, 1986.

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Drug patent expirations by year for ROBINUL
Drug Prices for ROBINUL

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Recent Clinical Trials for ROBINUL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
McGill University Health CenterN/A
Oulu University HospitalPhase 4
University of OuluPhase 4

See all ROBINUL clinical trials

Pharmacology for ROBINUL
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Synonyms for ROBINUL
.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
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 (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 ROBINUL
Tradename Dosage Ingredient NDA Submissiondate
ROBINUL FORTE TABLET;ORAL glycopyrrolate 012827 2010-10-12
ROBINUL TABLET;ORAL glycopyrrolate 012827 2010-10-12
ROBINUL TABLET;ORAL glycopyrrolate 012827 2009-08-14
ROBINUL FORTE TABLET;ORAL glycopyrrolate 012827 2009-08-14

US Patents and Regulatory Information for ROBINUL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma ROBINUL glycopyrrolate INJECTABLE;INJECTION 017558-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Casper Pharma Llc ROBINUL FORTE glycopyrrolate TABLET;ORAL 012827-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Robins Ah ROBINUL glycopyrrolate INJECTABLE;INJECTION 014764-001 Approved Prior to Jan 1, 1982 DISCN 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

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