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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.

Summary for tirofiban hydrochloride

International Patents:	12
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	4
Suppliers / Packagers:	1
Bulk Api Vendors:	100
Clinical Trials:	42
Patent Applications:	1,467
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tirofiban hydrochloride
DailyMed Link:	tirofiban hydrochloride at DailyMed

Recent Clinical Trials for tirofiban hydrochloride

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Sponsor	Phase
Assiut University	Phase 1/Phase 2
Shanghai Zhongshan Hospital	Phase 4
Kaifeng Central Hospital	N/A

See all tirofiban hydrochloride clinical trials

Recent Litigation for tirofiban hydrochloride

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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 Trial	12.5MG/260ML	INJECTABLE; 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

Drug Class	Platelet Aggregation Inhibitor
Physiological Effect	Decreased Platelet Aggregation

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

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Glossary

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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

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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

International Patents for tirofiban hydrochloride

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Country	Patent Number	Estimated Expiration
Australia	2003234596	Start Trial
Canada	2483929	Start Trial
Canada	2318215	Start Trial
World Intellectual Property Organization (WIPO)	03092767	Start Trial
Japan	2005532306	Start Trial
European Patent Office	1503753	Start Trial
Japan	2002501936	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for tirofiban hydrochloride

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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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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.

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