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

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Last Updated: November 12, 2019

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Tirofiban hydrochloride - Generic Drug Details

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

Tirofiban hydrochloride is the generic ingredient in one branded drug marketed by Medicure and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tirofiban hydrochloride has twelve patent family members in six countries.

There are four drug master file entries for tirofiban hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for tirofiban hydrochloride

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

SponsorPhase
Assiut UniversityPhase 1/Phase 2
Shanghai Zhongshan HospitalPhase 4
Kaifeng Central HospitalN/A

See all tirofiban hydrochloride clinical trials

Recent Litigation for tirofiban hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
MEDICURE INTERNATIONAL, INC. v. GLAND PHARMA LTD.2018-11-16

See all tirofiban hydrochloride litigation

Generic filers with tentative approvals for TIROFIBAN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial12.5MG/260MLINJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for tirofiban hydrochloride
Synonyms for tirofiban hydrochloride
(2S)-2-(butylsulfonylamino)-3-[4-(4-piperidin-4-ylbutoxy)phenyl]propanoic acid hydrate hydrochloride
(2S)-2-(butylsulfonylamino)-3-[4-(4-piperidin-4-ylbutoxy)phenyl]propanoic acid hydrochloride
(2S)-2-(butylsulfonylamino)-3-[4-(4-piperidin-4-ylbutoxy)phenyl]propanoic acid hydrochloride monohydrate
(2S)-2-(butylsulfonylamino)-3-[4-[4-(4-piperidyl)butoxy]phenyl]propanoic acid hydrate hydrochloride
(2S)-2-(butylsulfonylamino)-3-[4-[4-(4-piperidyl)butoxy]phenyl]propanoic acid hydrochloride
(2S)-2-(Butylsulfonylamino)-3-[4-[4-(4-piperidyl)butoxy]phenyl]propanoic acid hydrochloride hydrate
(S)-2-(BUTANE-1-SULFONYLAMINO)-3-[4-(4-PIPERIDIN-4-YL-BUTOXY)-PHENYL]-PROPIONIC ACID HCL HYDRATE
(S)-2-(Butylsulfonamido)-3-(4-(4-(piperidin-4-yl)butoxy)phenyl)propanoic acid hydrochloride
(S)-2-(Butylsulfonamido)-3-(4-(4-(piperidin-4-yl)butoxy)phenyl)propanoic acid hydrochloride hydrate
142373-60-2
144494-65-5 (Parent)
150915-40-5
2-(butylsulfonylamino)-3-[4-[4-(4-piperidinyl)butoxy]phenyl]propanoic acid hydrochloride
373T602
6H925F8O5J
915T405
AB0005248
AC1L1U7L
AC1L21WW
AC1Q3ETP
AC1Q3ETQ
ACT04424
Aggrastat (TN)
AKOS025311245
AKOS027327567
AN-15411
AN-7594
API0014445
AS-11027
AX8154228
BCP06919
BG0585
C22H36N2O5S.HCl
C22H39ClN2O6S
CAS-150915-40-5
CCG-222411
CHEBI:9606
CHEMBL1704
CHEMBL3189072
CS-0948
CT0258
CTK4C6811
D01029
DSSTox_CID_28561
DSSTox_GSID_48635
DSSTox_RID_82833
DTXSID5048635
FT-0631165
FT-0675251
HY-17369
IKE1P4X57J
KB-61743
KS-00000XQQ
L 700462
L-Tyrosine, N-(butylsulfonyl)-O-(4-(4-piperidinyl)butyl)-, monohydrochloride
L-Tyrosine, N-(butylsulfonyl)-O-(4-(4-piperidinyl)butyl)-, monohydrochloride, monohydrate
LS-173142
MK 383
MK-383 Hydrochloride
MolPort-006-823-927
N-(Butylsulfonyl)-4-(4-(4-piperidyl)butoxy)-L-phenylalanine monohydrochloride monohydrate
N-(Butylsulfonyl)-O-(4-(4-piperidinyl)butyl)-L-tyrosine monohydrochloride
N-(Butylsulfonyl)-O-(4-(4-piperidinyl)butyl)-L-tyrosine monohydrochloride monohydrate
N-(butylsulfonyl)-O-(4-piperidin-4-ylbutyl)-L-tyrosine hydrochloride monohydrate
N-(Butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine hydrochloride
N-(Butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine Monohydrochloride Monohydrate
N-(Butylsulfonyl)-O-[4-(4-piperidynyl)butyl]-L-tyrosine Hydrochloride Hydrate
n-(butylsulfonyl)-o-[4-(piperidin-4-yl)butyl]-l-tyrosine hydrochloride(1:1)
NCGC00182085-01
NCGC00263584-01
Q-101314
RT-016037
s8594
SB19198
SC-27175
SCHEMBL41325
SCHEMBL41327
Tirofiban (hydrochloride monohydrate)
Tirofiban HCl
Tirofiban HCl hydrate
Tirofiban HCl monohydrate
Tirofiban Hydrochloride (anhydrous)
Tirofiban hydrochloride (USAN)
Tirofiban hydrochloride [USAN]
Tirofiban hydrochloride anhydrous
Tirofiban hydrochloride hydrate
Tirofiban hydrochloride monohydrate
Tirofiban hydrochloride monohydrate, >=98% (HPLC)
Tirofiban, Hydrochloride Hydrate
Tirofibanhydrochloride monohydrate
Tox21_112980
Tox21_112980_1
UNII-6H925F8O5J
UNII-IKE1P4X57J
W-5345
Y0428
Paragraph IV (Patent) Challenges for TIROFIBAN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
AGGRASTAT INJECTABLE;INJECTION tirofiban hydrochloride 020913 2019-08-29
AGGRASTAT INJECTABLE;INJECTION tirofiban hydrochloride 020913 2018-10-03

US Patents and Regulatory Information for tirofiban hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INJECTION 020912-002 Aug 31, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-001 May 14, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-003 Apr 20, 2000 RX Yes Yes   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-002 May 17, 2002 RX Yes No   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INJECTION 020912-002 Aug 31, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-003 Apr 20, 2000 RX Yes Yes   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 tirofiban hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-002 May 17, 2002   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INJECTION 020912-002 Aug 31, 2016   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-001 May 14, 1998   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-003 Apr 20, 2000   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-001 May 14, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tirofiban hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0478363 2000C/002 Belgium   Start Trial PRODUCT NAME: TIROFIBANUM HYDROCHLORIDUM (EQ. TIROFIBAN); NAT. REGISTRATION NO/DATE: 922 IS 191 F 12 19990906; FIRST REGISTRATION: CH 54761 19980528
0478363 C990040 Netherlands   Start Trial PRODUCT NAME: TIROFIBAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF EEN HYDRAAT, IN HET BIJZONDER TIROFIBANHY- DROCHLORIDE MONOHYDRAAT; NATL REGISTRATION NO/DATE: RVG 23380-1 19990707; FIRST REGISTRATION: DE 42618.00.00-01 19980630
0478363 48/1999 Austria   Start Trial PRODUCT NAME: TIROFIBAN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: 1-23140 UND 1-23141 19990714; FIRST REGISTRATION: LI IKS-NR 54761 19980528
0478363 SPC/GB99/042 United Kingdom   Start Trial PRODUCT NAME: TIROFIBAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE HYDROCHLORIDE; REGISTERED: LI 54761 19980528; CH 54761 19980528; DE 42618.00.00 19980630; DE 42618.00.01 19980630; DE 42620.00.00 19980630; DE 42620.00.01 19980630; UK PL 00025/0375 19990715; UK PL 00025/0376 19990715
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School
Moodys

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