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 22, 2019

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Buspirone hydrochloride - Generic Drug Details

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What are the generic sources for buspirone hydrochloride and what is the scope of patent protection?

Buspirone hydrochloride is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Accord Hlthcare, Amneal Pharms Co, Aurobindo Pharma Ltd, Egis, Epic Pharma Llc, Fosun Pharma, Heritage Pharma, Impax Labs Inc, Inventia Hlthcare, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Oxford Pharms, Rubicon, Strides Pharma, Teva, Yiling Pharm Ltd, and Zydus Pharms, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for buspirone hydrochloride. Forty-seven suppliers are listed for this compound.

Recent Clinical Trials for buspirone hydrochloride

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SponsorPhase
VA Office of Research and DevelopmentPhase 4
University of LouisvilleEarly Phase 1
Ecole Polytechnique Fédérale de LausannePhase 1

See all buspirone hydrochloride clinical trials

Recent Litigation for buspirone hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Sanofi-Synthelabo v. Apotex Inc.2002-03-21

See all buspirone hydrochloride litigation

Medical Subject Heading (MeSH) Categories for buspirone hydrochloride
Synonyms for buspirone hydrochloride
1-[4-(7,9-dioxo-8-azaspiro[4.5]decan-8-yl)butyl]-4-(pyrimidin-2-yl)piperazin-1-ium chloride
1,1-Cyclopentanediacetimide, N-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-, hydrochloride
207LT9J9OC
33386-08-2
8-(4-(4-(2-Pyrimidinyl)-1-piperazinyl)butyl)-8-azaspiro(4.5)decane-7,9-dione hydrochloride
8-(4-(4-(2-Pyrimidinyl)-1-piperazinyl)butyl)-8-azaspiro(4.5)decane-7,9-dione monohydrochloride
8-(4-(4-(pyrimidin-2-yl)piperazin-1-yl)butyl)-8-azaspiro[4.5]decane-7,9-dione hydrochloride
8-[4-(4-pyrimidin-2-ylpiperazin-1-yl)butyl]-8-azaspiro[4.5]decane-7,9-dione hydrochloride
8-[4-(4-pyrimidin-2-ylpiperazin-1-yl)butyl]-8-azaspiro[4.5]decane-7,9-dione;hydrochloride
8-[4-(4-pyrimidin-2-ylpiperazinyl)butyl]-8-azaspiro[4.5]decane-7,9-dione, chlo ride
8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione
8-[4-[4-(2-Pyrimidinyl)-1-pipirazinyl]butyl]-8-azaspiro[4,5]decane-7,9-dione hydrochloride
8-[4-[4-(pyrimidine-2-yl)-piperazine-1-yl]-butyl]-8-aza-spiro[4.5]decane-7,9-dione hydrochloride
8-{4-[4-(pyrimidin-2-yl)piperazin-1-yl]butyl}-8-azaspiro[4.5]decane-7,9-dione hydrochloride
8-Azaspiro(4,5)decane-7,9-dione, 8-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-, monohydrochloride
8-Azaspiro(4,5)decane-7,9-dione,8-(4-(4-(2-pyrimidinyl)piperizinyl)butyl)
8-Azaspiro(4.5)decane-7,9-dione, 8-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-,monohydrochloride
8-Azaspiro[4.5]decane-7, 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-, monohydrochloride
AC-1905
AC1L1VQO
AC1Q3EKR
AKOS015962019
AN-14507
Ansiced
Ansitec
Anxinil
Anxiolan
APC-6002
APC-6003
Apo-Buspirone
Axoren
B 7148
Barpil
BC228667
BCP28463
Bespar
Biron
Busirone
Buspar
Buspar (TN)
Buspimen
Buspinol
Buspirone (hydrochloride)
Buspirone for system suitability, European Pharmacopoeia (EP) Reference Standard
Buspirone HCL
Buspirone hydrochloride (USP)
Buspirone hydrochloride [USAN:USP]
Buspirone hydrochloride [USAN]
Buspirone Hydrochloride 1.0 mg/ml in Methanol (as free base)
Buspirone hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Buspirone hydrochloride, European Pharmacopoeia (EP) Reference Standard
Buspirone hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Buspirone hydrochloride, United States Pharmacopeia (USP) Reference Standard
C21H31N5O2.HCl
C21H32ClN5O2
CCG-213652
Censpar
CHEBI:3224
CHEMBL1200399
CPD000058186
CS-4714
CTK8F8364
D00702
DTXSID1037193
Effiplen
EINECS 251-489-4
Establix
EU-0100223
FT-0623290
H05B847
HMS1569I19
HY-B1115
Itagil
J10144
Jsp006125
K-7699
Kallmiren
KS-000018A2
KS-5163
LP00223
LS-22724
Lucelan
Mabuson
MCULE-3504513666
MFCD00078569
MJ 9022-1
MLS000069796
MLS001076085
MLS002548862
MolPort-002-163-732
N-(4-(4-(2-Pyrimidinyl)-1-piperazinyl)butyl)-1,1-cyclopentanediacetamide monohydrochloride
N-[4-(4-[2-Pyrimidinyl]-1-piperazinyl)butyl]-8-azaspiro[4, 5]decane-7, 9-dione
N-[4-[4-(2-Pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione hydrochloride
Narol
NC00673
NCGC00093692-01
NCGC00093692-02
NCGC00260908-01
Nerbet
Normaton
NSC-751138
NSC-759571
NSC751138
NSC759571
Opera_ID_707
Pharmakon1600-02300173
Prestwick_711
Q-200768
Relac
RICLFGYGYQXUFH-UHFFFAOYSA-N
s4256
SAM002264597
Sburol
SCHEMBL41495
SMR000058186
Spamilan
SR-01000075541
SR-01000075541-1
SR-01000075541-3
SR-01000075541-7
ST51014924
SW155073-5
Tox21_500223
Travin
Tutran
UNII-207LT9J9OC
VA10444
Paragraph IV (Patent) Challenges for BUSPIRONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
BUSPAR TABLET;ORAL buspirone hydrochloride 018731

US Patents and Regulatory Information for buspirone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 202557-002 Dec 30, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Teva BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075022-004 Mar 25, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Inventia Hlthcare BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 209696-003 May 3, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Inventia Hlthcare BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 209696-002 May 3, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 076008-004 Mar 1, 2002 AB RX 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

Expired US Patents for buspirone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb BUSPAR buspirone hydrochloride TABLET;ORAL 018731-003 Apr 22, 1996   Start Trial   Start Trial
Bristol Myers Squibb BUSPAR buspirone hydrochloride TABLET;ORAL 018731-003 Apr 22, 1996   Start Trial   Start Trial
Bristol Myers Squibb BUSPAR buspirone hydrochloride TABLET;ORAL 018731-002 Sep 29, 1986   Start Trial   Start Trial
Bristol Myers Squibb BUSPAR buspirone hydrochloride CAPSULE;ORAL 021190-001 Dec 20, 2000   Start Trial   Start Trial
Bristol Myers Squibb BUSPAR buspirone hydrochloride TABLET;ORAL 018731-004 Apr 22, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Medtronic

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.