Viewing data from:

ANGIOMAX

NDA

BIVALIRUDIN | N020873 | SANDOZ INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)TodayPED (+6 mo)

2027

2028

2029

Today

7582727

Jan. 27, 2029

7598343

Jan. 27, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
THE MEDICINES COMPANY v. EAGLE PHARMACEUTICALS, INC. et al 2:2016cv00569 2 patentsbivalirudin	D.N.J.	2016-02-02	Terminated 2017-12-19	—
THE MEDICINES COMPANY v. AUROBINDO PHARMA LIMITED et al 3:2014cv02367 2 patentsANDA 205962bivalirudin	D.N.J.	2014-04-11	Terminated 2017-11-22	—
THE MEDICINES COMPANY v. APOTEX INC. et al 3:2013cv02801 2 patentsANDA 204876bivalirudin	D.N.J.	2013-05-01	Terminated 2018-05-02	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Angiomax (2023)

Total Spending

$4K

Total Claims

Beneficiaries

ASP Price

—

HCPCS: J0583 — Injection, bivalirudin, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain10 active DMFs2 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVBIVALIRUDIN

DMF 208632007

DR REDDYS LABORATORIES LTDBIVALIRUDIN

DMF 236562010

ALP PHARM BEIJING CO LTDBIVALIRUDIN

DMF 242572010

SUN PHARMACEUTICAL INDUSTRIES LTDBIVALIRUDIN

DMF 244232011

CHENGDU SHENGNUO BIOPHARM CO LTDBIVALIRUDIN (NON-STERILE BULK DRUG)

DMF 255312012

SCINOPHARM TAIWAN LTDBIVALIRUDIN

DMF 256342011

HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDBIVALIRUDIN

DMF 300712016

SHENZHEN SALUBRIS PHARMACEUTICALS CO LTDBIVALIRUDIN

DMF 302152016

BACHEM AGBIVALIRUDIN

DMF 314582017

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDBIVALIRUDIN

DMF 322812018

POLYPEPTIDE SAInactiveBIVALIRUDIN (TM-001-2G)

DMF 289122014

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDInactiveBIVALIRUDIN (PROCESS II)

DMF 352592020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Jul 5, 2019	SUPPL -39	View Letter (PDF)
Mar 22, 2016	SUPPL -36	View Letter (PDF)
May 22, 2013	SUPPL -29	View Letter (PDF)
Jun 29, 2010	SUPPL -23	View Letter (PDF)
Dec 5, 2005	SUPPL -11	View Letter (PDF)
Sep 8, 2005	SUPPL -14	View Letter (PDF)
Jun 15, 2005	SUPPL -6	View Letter (PDF)
May 7, 2004	SUPPL -9	View Letter (PDF)
Jun 20, 2002	SUPPL -4	View Letter (PDF)
Dec 15, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG/VIAL

RLDAP

2 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Dec 15, 2000

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7582727	Jul 27, 2028PED: Jan 27, 2029	PED	—	Yes	—	—
7598343	Jul 27, 2028PED: Jan 27, 2029	PED	—	Yes	—	—