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Last Updated: May 31, 2020

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Zaleplon - Generic Drug Details

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What are the generic drug sources for zaleplon and what is the scope of freedom to operate?

Zaleplon is the generic ingredient in two branded drugs marketed by Pfizer, Aurobindo Pharma, Cipla Ltd, Hikma, Hikma Pharms, Mylan, Orchid Hlthcare, Teva Pharms, Unichem, and Upsher Smith Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for zaleplon. Eight suppliers are listed for this compound.

Drug Prices for zaleplon

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Recent Clinical Trials for zaleplon

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SponsorPhase
Saint-Joseph UniversityPhase 3
Chang Gung Memorial HospitalPhase 2/Phase 3
Taipei City HospitalPhase 2/Phase 3

See all zaleplon clinical trials

Recent Litigation for zaleplon

Identify potential future generic entrants

District Court Litigation
Case NameDate
KING PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC.2005-08-02
KING PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC.

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Pharmacology for zaleplon
Synonyms for zaleplon
151319-34-5
3'-(3-Cyanopyrazolo(1,5-a)pyrimidin-7-yl)-N-ethylacetanilide
3'-(3-Cyanopyrazolo(1,5-alpha)pyrimidin-7-yl)-N-ethylacetanilide
319Z345
A12993
A809159
AB0005251
AB00640003_03
AC-2082
Acetamide, N-(3-(3-cyanopyrazolo(1,5-a)pyrimidin-7-yl)phenyl)-N-ethyl-
Acetamide, N-(3-(3-cyanopyrazolo(1,5-alpha)pyrimidin-7-yl)phenyl)-N-ethyl-
ACMC-20n66f
ACT04427
AKOS000280863
API0004637
AZ-007
BCP21340
BDBM86521
BIDD:GT0046
C-19022
C07484
C17H15N5O
CAS_5719
CAS-151319-34-5
CC-35666
cc-94
CCG-101187
CHEBI:10102
CHEMBL1521
CL 284,846
CL 284846
CL-284846
CL284,846
CPD000238180
CS-2763
CTK4C7001
CZ0011
D00530
DB-015068
DB00962
DEA No. 2781
DSSTox_CID_3748
DSSTox_GSID_23748
DSSTox_RID_77183
DTXSID5023748
FT-0631182
GTPL4345
HMS2052J11
HMS3394J11
HMS3713H08
HUNXMJYCHXQEGX-UHFFFAOYSA-N
HY-14265
L 846
L-846
L846
LJC 10846
LJC-10846
LS-173402
LS-8737
MFCD00867990
MLS000759451
MLS001424238
N-(3-(3-Cyanopyrazolo(1,5-a)pyrimidin-7-yl)phenyl)-N-ethylacetamide
N-(3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl)-N-ethylacetamide
N-(3-{3-cyanopyrazolo[1,5-a]pyrimidin-7-yl}phenyl)-N-ethylacetamide
N-[3-(3-cyano-7-pyrazolo[1,5-a]pyrimidinyl)phenyl]-N-ethylacetamide
N-[3-(3-cyanopyrazolo-[1,5-a]-pyrimidin-7-yl)-phenyl]-N-ethyl acetamide
N-[3-(3-Cyanopyrazolo-[1,5-a]pyrimidin-7-yl)phenyl)-N-ethylacetamide
N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethyl-ethanamide
N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide
N-[3-(Cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide
NC00437
NCGC00160525-01
NCGC00160525-02
NSC_5719
Q145052
RW2340
S62U433RMH
SAM001246641
SCHEMBL29118
SKP-1041
SMR000238180
Sonata
Sonata (TN)
SR-01000759426
SR-01000759426-3
SS-4571
Staccato-zaleplon
Tox21_111872
Tox21_111872_1
UNII-S62U433RMH
ZAL 846
ZAL-846
Zaleplon (JAN/USAN/INN)
Zaleplon [USAN:INN]
Zaleplon [USAN:USP:INN:BAN]
Zaleplon 1.0 mg/ml in Methanol
Zaleplon AP
Zaleplon civ
Zaleplon solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Zaleplon, >=98% (HPLC), solid
Zaleplon, United States Pharmacopeia (USP) Reference Standard
Zerene
ZINC000000006300
ZINC6300
Paragraph IV (Patent) Challenges for ZALEPLON
Tradename Dosage Ingredient NDA Submissiondate
SONATA CAPSULE;ORAL zaleplon 020859 2005-06-21

US Patents and Regulatory Information for zaleplon

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipla Ltd ZALEPLON zaleplon CAPSULE;ORAL 077505-002 Jun 20, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma Pharms ZALEPLON zaleplon CAPSULE;ORAL 078147-001 Nov 25, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla Ltd ZALEPLON zaleplon CAPSULE;ORAL 077505-001 Jun 20, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Upsher Smith Labs ZALEPLON zaleplon CAPSULE;ORAL 078706-002 Jun 6, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Orchid Hlthcare ZALEPLON zaleplon CAPSULE;ORAL 090374-001 Sep 17, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan ZALEPLON zaleplon CAPSULE;ORAL 077238-002 Jun 6, 2008 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Mallinckrodt
Moodys
Express Scripts
Harvard Business School

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 verification 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.