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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 17, 2019

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Acetylcysteine - Generic Drug Details

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What are the generic drug sources for acetylcysteine and what is the scope of patent protection?

Acetylcysteine is the generic ingredient in seven branded drugs marketed by Cumberland Pharms, Akorn Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms Inc, Zydus Pharms, Alvogen Inc, Hospira, Luitpold, Roxane, Apothecon, DEY, Arbor Pharms Llc, and Mead Johnson, and is included in twenty-four NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetylcysteine has eighteen patent family members in ten countries.

There are three drug master file entries for acetylcysteine. Eleven suppliers are listed for this compound.

Drug Prices for acetylcysteine

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Recent Clinical Trials for acetylcysteine

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SponsorPhase
Istanbul Medipol University HospitalPhase 2
Sahlgrenska University Hospital, SwedenPhase 2
Alanya Alaaddin Keykubat UniversityPhase 2

See all acetylcysteine clinical trials

Recent Litigation for acetylcysteine

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District Court Litigation
Case NameDate
Cumberland Pharmaceuticals Inc. v. Akorn Inc.2013-07-12
Cumberland Pharmaceuticals Inc. v. Sagent Agila LLC2012-06-26
Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC2012-05-17

See all acetylcysteine litigation

Medical Subject Heading (MeSH) Categories for acetylcysteine
Synonyms for acetylcysteine
(2R)-2-(acetylamino)-3-mercaptopropanoic acid
(2R)-2-(acetylamino)-3-sulfanylpropanoic acid
(2R)-2-[(Z)-(1-hydroxyethylidene)amino]-3-sulfanylpropanoic acid
(2R)-2-Acetamido-3-sulfanyl-propanoic acid
(2R)-2-acetamido-3-sulfanylpropanoic acid
(2R)-2-acetylamino-3-mercapto-propionic acid
(2R)-2-acetylamino-3-sulfanylpropanoic acid
(R)-2-Acetamido-3-mercaptopropanoic acid
(R)-2-acetylamino-3-mercaptopropanoic acid
(R)-mercapturic acid
1-alpha-Acetamido-beta-mercaptopropionic acid
1261105-20-7
16A911
18829-79-3 (hydrochloride)
19542-74-6 (mono-hydrochloride salt)
2-Acetylamino-3-mercapto-propionate
2-Acetylamino-3-mercapto-propionic acid
616-91-1
63664-54-0 (hydrochloride salt)
66233-EP2298305A1
66233-EP2308851A1
7696-05-1
A 7250
A-1100
A0905
AB0013800
AB00382974_13
AB00382974-12
AB1002786
AC-16071
AC-24117
Ac-Cys-OH
AC1L1YP9
AC1Q1K99
AC1Q1K9A
AcCys
Acetadote
Acetein
Acetilcisteina
Acetilcisteina [INN-Spanish]
acetyl cysteine
Acetyl Cysteine,(S)
Acetyl-L-cysteine
Acetylcysteine (JP17/USP/INN)
acetylcysteine (n-acetyl-l-cysteine)
Acetylcysteine [USAN:INN:BAN]
Acetylcysteine [USAN:USP:INN:BAN:JAN]
Acetylcysteine, British Pharmacopoeia (BP) Reference Standard
Acetylcysteine, European Pharmacopoeia (EP) Reference Standard
Acetylcysteine, United States Pharmacopeia (USP) Reference Standard
Acetylcysteinum
Acetylcysteinum [INN-Latin]
Airbron
AJ-45053
AK-46577
AKOS015841009
AM20100502
AN-769
ANTIOXIDANT MODEL (TRAMP) -N-ACETYLCYSTEINE
ANW-33915
BC209913
BDBM50420190
BP-12854
BR-46577
BRD-K59058747-001-20-9
Broncholysin
Brunac
BSPBio_001794
C06809
CABC898A-E48B-4E13-9F72-98D0609A1854
CAS-616-91-1
CCG-204176
CCRIS 3764
Cetylev
CHEBI:28939
CHEMBL600
component of Naxid
CS-2160
CTK2F2887
cysteine, N-acetyl-
Cysteine, N-acetyl-, L-
D00221
DB-038288
DB06151
DSSTox_CID_21
DSSTox_GSID_20021
DSSTox_RID_75324
DTXSID5020021
EINECS 210-498-3
EN300-72028
EU-0100081
Exomuc
F1905-7178
Fabrol
Fluatox
Fluimicil Infantil
Fluimucetin
Fluimucil
Flumil
Flumucetin
Fluprowit
FT-0629832
GS-3121
HMS2234J22
HMS3260A04
HMS3655G11
HMS3715D03
HSDB 3003
HY-B0215
I630
Ilube
Inspir
J-507685
KB-47112
KBio3_001294
KBioGR_000554
KS-0000026W
KSC352Q8P
L-.alpha.-Acetamido-.beta.-mercaptopropionic acid
L-Acetylcysteine
L-alpha-Acetamido-beta-mercaptopropionic acid
L-Cysteine, N-acetyl-
L-Cysteine, N-acetyl- & Tumor necrosis factor
LNAC
LNAC; NAC,L-alpha-Acetamido-beta-mercaptopropionic acid; Mercapturic acid
Lopac0_000081
LP00081
LS-2165
Lysomucil
Lysox
mercapturic acid
Mercapturic acid, (R)-
MFCD00004880
MLS000028419
MLS001076125
MLS006011563
MolPort-000-150-826
Muco sanigen
Mucocedyl
Mucofilin
Mucolator
Mucolyticum
Mucolyticum Lappe
Mucolyticum-Lappe
Mucolytikum Lappe
Mucomyst
MUCOMYST (TN)
Mucosil
MUCOSIL-10
MUCOSIL-20
Mucosolvin
Mucret
N-Acety-L-Cysteine
N-Acetyl cysteine
N-acetyl-(R)-cysteine
N-Acetyl-3-mercaptoalanine
N-Acetyl-cysteine
N-Acetyl-L-(+)-cysteine
N-acetyl-l-cys
N-acetyl-L-cystein
N-Acetyl-L-cysteine
N-Acetyl-L-cysteine & Tumor necrosis factor (TNF)
N-Acetyl-L-cysteine hydrochloride
N-Acetyl-L-cysteine, 98%
N-Acetyl-L-cysteine, BioXtra, >=99% (TLC)
N-Acetyl-L-cysteine, cell culture tested, BioReagent
N-Acetyl-L-cysteine, Pharmaceutical Secondary Standard; Certified Reference Material
N-Acetyl-L-cysteine, PharmaGrade, Ajinomoto, Manufactured under appropriate GMP controls for pharma or biopharmaceutical production, suitable for cell culture
N-Acetyl-L-cysteine, SAJ special grade, 98.0-102.0%
N-Acetyl-L-cysteine, Sigma Grade, >=99% (TLC), powder
N-Acetyl-L-cysteine, Vetec(TM) reagent grade, 98%
N-Acetyl-N-Cysteine
N-acetylcystein
N-Acetylcysteine
NAC
NAC & TNF
NAC-TB
Naxid (Salt/Mix)
NCGC00015086-04
NCGC00022304-03
NCGC00022304-04
NCGC00022304-05
NCGC00022304-06
NCGC00022304-07
NCGC00022304-08
NCGC00258631-01
NCGC00260766-01
Neo-fluimucil
NSC 111180
NSC-111180
NSC111180
Opera_ID_452
Parvolex
PubChem12963
PWKSKIMOESPYIA-BYPYZUCNSA-N
Respaire
RK-0202
RP22622
RTC-066653
s1623
SC-09436
SC2
SCHEMBL5292
SMR000058377
Sodium 2-acetamido-3-mercaptopropionate
SPBio_000012
Spectrum2_000086
Spectrum3_000287
Spectrum4_000137
Spectrum5_000764
SR-01000075439
SR-01000075439-1
SR-01000075439-3
SR-01000075439-5
ST2408139
ST50824849
SW199597-2
Syntemucol
TC-066653
Tixair
TL8003928
Tox21_110877
Tox21_110877_1
Tox21_201078
Tox21_500081
UNII-2SPH1IMO2V component PWKSKIMOESPYIA-BYPYZUCNSA-N
UNII-WYQ7N0BPYC
WYQ7N0BPYC
ZINC3589203
Paragraph IV (Patent) Challenges for ACETYLCYSTEINE
Tradename Dosage Ingredient NDA Submissiondate
ACETADOTE INJECTABLE;INTRAVENOUS acetylcysteine 021539 2012-04-04

US Patents and Regulatory Information for acetylcysteine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Institutional ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 203624-001 Jun 19, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-001 Jan 29, 2016 DISCN Yes No   Start Trial   Start Trial   Start Trial
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-001 Jan 29, 2016 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Roxane ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072323-001 Apr 30, 1992 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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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.