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AstraZeneca
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Generated: October 16, 2018

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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 freedom to operate?

Bivalirudin is the generic ingredient in three branded drugs marketed by The Medicines Co, Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Hospira Inc, Mylan Institutional, Sagent Pharms, 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. Nine 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
128270-60-0
270B600
70B600
8-Methoxy-naphtho[2,3-b]thiophen-4,9-quinone
AKOS015994644
AM006888
AN-7543
Angiomax
Angiomax (TN)
Angiox
BC657176
BG 8967
BG-8967
BG8967
Bivalirudin [USAN:BAN:INN]
Bivalirudin [USAN:INN:BAN]
Bivalirudin Trifluoacetate
Bivalirudin Trifluoroacetate
bivalirudina
bivalirudine
bivalirudinum
C98H138N24O33
C9H11NO.C2H6.CH4
CHEBI:59173
CHEMBL2103749
D-Phenylalanyl-L-prolyl-L-arginyl-L-prolylglycylglycylglycylglycyl-L-asparaginylglycyl-L-alpha-aspartyl-L-phenylalanyl-L-alpha-glutamyl-L-alpha-glutamyl-L-isoleucyl-L-prolyl-L-alpha-glutamyl-L-alpha-glutamyl-L-tyrosyl-L-leuci
D03ZVY
D09FGS
D09HVL
D0F4HO
DB00006
EBD32115
GTPL6470
Hirulog
Hirulog-1
HS-2004
J-005587
KS-00002WUN
L-Leucine, D-phenylalanyl-L-prolyl-L-arginyl-L-prolylglycylglycylglycylglycyl-L-asparaginylglycyl-L-alpha-aspartyl-L-phenylalanyl-L-alpha-glutamyl-L-alpha-glutamyl-L-isoleucyl-L-prolyl-L-alpha-glutamyl-L-alpha-glutamyl-L-tyro
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
The Medicines Company brand of bivalirudin
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
Baxter Hlthcare Corp BIVALIRUDIN IN 0.9% SODIUM CHLORIDE bivalirudin SOLUTION;INTRAVENOUS 208374-002 Dec 21, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 204876-001 Jul 6, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
The Medicines Co ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Aurobindo Pharma Ltd BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 205962-001 Jul 27, 2018 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
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
Sagent Pharms BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 091602-001 Jul 16, 2018 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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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
QuintilesIMS
McKesson
Fuji
Covington
Daiichi Sankyo
Baxter
Boehringer Ingelheim
Cerilliant

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