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Generated: March 20, 2019

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Bivalirudin - Generic Drug Details

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What are the generic drug sources for bivalirudin and what is the scope of bivalirudin patent protection?

Bivalirudin is the generic ingredient in three branded drugs marketed by Sandoz Inc, 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 eleven NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for bivalirudin. Twelve suppliers are listed for this compound. There are four tentative approvals for this compound.

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
Tentative approvals for BIVALIRUDIN
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial250MG/VIALINJECTABLE;INTRAVENOUS
➤ Try a Free Trial➤ Try a Free Trial250MGINJECTABLE;INJECTION
➤ Try a Free Trial➤ Try a Free Trial250MGINJECTABLE;INJECTION

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
Hospira Inc BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090816-001 Jul 14, 2015 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hospira Inc BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090811-001 Jul 14, 2015 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090189-001 Oct 28, 2016 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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