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Last Updated: November 20, 2019

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BIVALIRUDIN Drug Profile

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When do Bivalirudin patents expire, and what generic alternatives are available?

Bivalirudin is a drug marketed by Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Hospira Inc, Mylan Institutional, and Baxter Hlthcare Corp. and is included in ten NDAs.

The generic ingredient in BIVALIRUDIN is bivalirudin. There are fourteen drug master file entries for this compound. Twelve suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the bivalirudin profile page.

Drug patent expirations by year for BIVALIRUDIN
Drug Prices for BIVALIRUDIN

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Recent Clinical Trials for BIVALIRUDIN

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SponsorPhase
Legacy Health SystemPhase 4
Pacific UniversityPhase 4
Shenyang Northern HospitalN/A

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Recent Litigation for BIVALIRUDIN

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District Court Litigation
Case NameDate
Medicines Company v. Hospira, Inc.2014-05-13
The Medicines Company v. Hospira, Inc.2014-05-13
The Medicines Company v. Exela Pharma Sciences, LLC2014-04-25

See all BIVALIRUDIN litigation

Pharmacology for BIVALIRUDIN
Synonyms for BIVALIRUDIN
(R,R)-2,6-Bis(4,5-dihydro-4-phenyl-2-oxazolyl)pyridine; (R,R)-2,6-Bis(4-phenyl-2-oxazolinyl)pyridine; (+)-2,6-Bis[(4R)-4-phenyl-2-oxazolin-2-yl]pyridine
1191386-55-6
128270-60-0
270B600
70B600
AKOS015994644
AN-7543
Angiomax
Angiox
BC657176
BG 8967
BG-8967
BG8967
Bivalirudin [USAN:BAN:INN]
Bivalirudin [USAN:INN:BAN]
Bivalirudin Trifluoacetate
Bivalirudin Trifluoroacetate
Bivalirudin;0.9% Sodium Chloride
bivalirudina
bivalirudine
bivalirudinum
C98H138N24O33
C9H11NO.C2H6.CH4
CHEBI:59173
CHEMBL2103749
DB00006
EBD32115
GTPL6470
Hirulog
Hirulog-1
HS-2004
J-005587
KS-00002WUN
LS-172701
MolPort-006-167-455
Phe-Pro-Arg-Pro-(Gly)4 desulfato-Tyr63'-hirugen
Phe-Pro-Arg-Pro-(Gly)4-Asn-Gly-Asp-Phe-Glu-Glu-Ile-Pro-Glu-Glu-Tyr-Leu
Phe-Pro-Arg-Pro-(Gly)4-desulfohirudin-(53-64)
SCHEMBL25739
TN9BEX005G
UNII-TN9BEX005G
Paragraph IV (Patent) Challenges for BIVALIRUDIN
Tradename Dosage Ingredient NDA Submissiondate
ANGIOMAX INJECTABLE;INTRAVENOUS bivalirudin 020873 2009-09-01

US Patents and Regulatory Information for BIVALIRUDIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 206551-001 Nov 22, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira Inc BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090811-001 Jul 14, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Cipla BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 091602-001 Jul 16, 2018 AP 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

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