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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 tirofiban hydrochloride 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.

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:	137
Clinical Trials:	36
Patent Applications:	5,357
Formulation / Manufacturing:	see details
DailyMed Link:	tirofiban hydrochloride at DailyMed

Pharmacology for tirofiban hydrochloride

Drug Class	Platelet Aggregation Inhibitor
Physiological Effect	Decreased Platelet Aggregation

Synonyms for tirofiban hydrochloride

(2S)-2-(butane-1-sulfonamido)-3-{4-[4-(piperidin-4-yl)butoxy]phenyl}propanoic acid

(2S)-2-(butylsulfonylamino)-3-[4-(4-piperidin-4-ylbutoxy)phenyl]propanoic acid

(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

(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

(2S)-2-(Butylsulfonylamino)-3-{4-[4-(4-piperidyl)butoxy}phenyl propanoic acid

(2S)-2-(Butylsulfonylamino)-3-{4-[4-(4-piperidyl)butoxy}phenyl propanoic acid, N-(Butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine

(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

(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

140430-EP2277565A2

140430-EP2277566A2

140430-EP2277567A1

140430-EP2277568A2

140430-EP2277569A2

140430-EP2277570A2

140430-EP2292280A1

142373-60-2

142373-60-2 (hydrochloride)

144494-65-5

144494-65-5 (Parent)

150915-40-5

151065-53-1

373T602

494T655

6H925F8O5J

915T405

AB0005248

AB1009554

AC1L1U7L

AC1L1U7O

AC1L21WW

AC1Q3ETP

AC1Q3ETQ

AC1Q6VFB

ACT04424

AGG

Aggrastat

Aggrastat (TN)

aggrestat

Agrastat

Agrastat (TN)

AK326111

AK326170

AKOS015894972

AKOS025311245

AKOS027327567

AN-15411

AN-31474

AN-7594

API0005653

API0014445

AS-11027

AX8154227

AX8154228

BDBM50004058

BG0585

BIDD:GT0363

C07965

C22H36N2O5S

C22H36N2O5S.HCl

C22H39ClN2O6S

CAS-150915-40-5

CCG-222411

CHEBI:9605

CHEBI:9606

CHEMBL1704

CHEMBL3189072

CHEMBL916

COKMIXFXJJXBQG-NRFANRHFSA-N

CS-0948

CS-2829

CT0258

CTK4C6811

D01029

D08607

D0BN9X

DB00775

DR002726

DSSTox_CID_28561

DSSTox_GSID_48635

DSSTox_RID_82833

DTXSID20162730

DTXSID5048635

EBD44261

FT-0675251

FT-0773940

GGX234SI5H

GTPL6586

HSDB 7323

HY-17369

HY-17369B

IKE1P4X57J

J-524973

KB-269052

KB-61743

KS-00000H6G

KS-00000XQQ

L 700462

L-700,462

L-700462

L-Tyrosine, N-(butylsulfonyl)-O-(4-(4-piperidinyl)butyl)-

L-Tyrosine, N-(butylsulfonyl)-O-(4-(4-piperidinyl)butyl)-, monohydrochloride

L-Tyrosine, N-(butylsulfonyl)-O-(4-(4-piperidinyl)butyl)-, monohydrochloride, monohydrate

L700462;MK383

LS-173142

LS-173214

MFCD00868210

MFCD05237246

MFCD07368623

MK 383

MK-383

MK-383 Hydrochloride

MolPort-006-167-632

MolPort-006-823-927

MolPort-027-806-963

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-(4-piperidyl)butyl)-L-tyrosine

N-(butylsulfonyl)-O-(4-piperidin-4-ylbutyl)-L-tyrosine

N-(butylsulfonyl)-O-(4-piperidin-4-ylbutyl)-L-tyrosine hydrochloride monohydrate

N-(BUTYLSULFONYL)-O-[4-(4-PIPERIDINYL)BUTYL]-L-TYROSINE

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

n-(butylsulfonyl)-o-[4-(piperidin-4-yl)butyl]-l-tyrosine hydrochloride(1:1)

N-(n-butanesulfonyl)-O-(4-(4-piperidinyl)-butyl)-(s)-tyrosine

NCGC00182085-01

NCGC00263584-01

Q-101314

RL01804

RT-016037

s3085

s8594

SC-27175

SC-96683

SCHEMBL3685

SCHEMBL41325

SCHEMBL41327

tirofiban

Tirofiban (hydrochloride monohydrate)

Tirofiban (INN)

Tirofiban [BAN:INN]

Tirofiban [INN:BAN]

Tirofiban HCl

Tirofiban HCl hydrate

Tirofiban Hydrochloride (anhydrous)

tirofiban hydrochloride (monohydrate)

Tirofiban hydrochloride (USAN)

Tirofiban hydrochloride [USAN]

Tirofiban hydrochloride anhydrous

Tirofiban hydrochloride hydrate

Tirofiban hydrochloride monohydrate

Tirofiban hydrochloride monohydrate, >=98% (HPLC)

Tirofiban, >=98.5% (HPLC)

Tirofiban, Hydrochloride Hydrate

Tirofiban[BAN:INN]

TIROFIBANHYDROCHLORIDEMONOHYDRATE

tirofibanum

Tox21_112980

Tox21_112980_1

UNII-6H925F8O5J

UNII-GGX234SI5H

UNII-IKE1P4X57J

W-5345

Y0428

ZINC3806104

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	INJECTABLE;INJECTION	020913-001	May 14, 1998		DISCN	No	No
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998		DISCN	No	No
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-002	May 17, 2002		RX	Yes	No
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INJECTION	020912-002	Aug 31, 2016		RX	Yes	Yes

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Expired US Patents for tirofiban hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-003	Apr 20, 2000

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International Patents for tirofiban hydrochloride

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9938827
Australia	2003234596
European Patent Office	1068172
United Kingdom	9809793

Supplementary Protection Certificates for tirofiban hydrochloride

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00C/002	Belgium		PRODUCT NAME: TIROFIBANUM HYDROCHLORIDUM (EQ. TIROFIBAN); NAT. REGISTRATION NO/DATE: 922 IS 191 F 12 19990906; FIRST REGISTRATION: CH 54761 19980528
90040	Netherlands		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
/1999	Austria		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
C/GB99/042	United Kingdom		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