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GLYCOPYRROLATE Drug Profile

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When do Glycopyrrolate patents expire, and what generic alternatives are available?

Glycopyrrolate is a drug marketed by Abraxis Pharm, Amneal Pharms Co, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Luitpold, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Appco Pharma Llc, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Hikma Intl Pharms, Leading Pharma Llc, Natco Pharma Ltd, Nexgen Pharma, Par Pharm, Renata, Rising Pharms Inc, Santos Biotech, Sun Pharm Inds Ltd, and Vintage Pharms. and is included in twenty-seven NDAs.

The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are seventeen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for GLYCOPYRROLATE

US Patents:	0
Applicants:	22
NDAs:	27
Suppliers / Packagers:	28
Bulk Api Vendors:	63
Clinical Trials:	102
Patent Applications:	2,215
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLYCOPYRROLATE
DailyMed Link:	GLYCOPYRROLATE at DailyMed

Pharmacology for GLYCOPYRROLATE

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for GLYCOPYRROLATE

Adjuvants, Anesthesia

Muscarinic Antagonists

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

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
Vintage Pharms	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	090020-001	Oct 19, 2011	AA	RX	No	No
Santos Biotech	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	091182-001	Feb 3, 2014	AA	RX	No	No
Vintage Pharms	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	090020-002	Oct 19, 2011	AA	RX	No	No
Santos Biotech	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	091182-002	Feb 3, 2014	AA	RX	No	No

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