Viewing data from:

KENGREAL

NDA

CANGRELOR | N204958 | CHIESI USA INC

1 strength7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Active (7)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

Mar. 9, 2033

Jul. 10, 2035

Nov. 10, 2030

Jul. 10, 2035

Jul. 10, 2035

May. 13, 2029

Jul. 10, 2035

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
CHIESI USA, INC. et al v. GLAND PHARMA LTD. 2:2019cv21204 7 patentsANDA 213551cangrelor	D.N.J.	2019-12-09	Terminated 2022-06-29	—
CHIESI USA, INC. et al v. GLAND PHARMA LTD. 2:2019cv18565 8 patentsANDA 213551cangrelor	D.N.J.	2019-09-30	Terminated 2022-06-29	—
CHIESI USA, INC. et al v. MSN PHARMACEUTICALS INC. et al 2:2019cv18564 8 patentscangrelor	D.N.J.	2019-09-30	Terminated 2022-06-29	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

22 trials from ClinicalTrials.gov, 15 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)NCT01156571	Phase 3	Completed	The Medicines Company	11,145	2010-09 → 2012-12
Cangrelor Neonatal PK/PD and Safety Study NCT02765633	Phase 1	Completed	Chiesi Farmaceutici S.p.A.	22	2017-01-03 → 2019-12-23
Cangrelor in Comatose Survivors of OHCA Undergoing Primary PCI NCT04005729	Phase 4	Completed	University Medical Centre Ljubljana	30	2019-07-01 → 2021-11-27
Aspirin Resistance and Percutaneous Coronary Intervention (PCI)NCT01103440	Phase 2	Completed	Icahn School of Medicine at Mount Sinai	36	2007-04 → 2009-06
Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction NCT03551964	Phase 4	Completed	Faculty Hospital Kralovske Vinohrady	605	2018-08-01 → 2025-04-01
Cangrelor Ticagrelor Transition Study NCT01766466	Phase 2	Completed	The Medicines Company	12	2013-01 → 2013-02
Cangrelor Prasugrel Transition Study NCT01852019	Phase 2	Completed	The Medicines Company	12	2013-06 → 2013-07
Cangrelor Following Ticagrelor Loading vs Ticagrelor Loading Alone in STEMI NCT02943369	Phase 4	Completed	Attikon Hospital	30	2017-07-28 → 2017-12-26
Randomized Comparison of Cangrelor, Tirofiban and Prasugrel in Patients With STEMI Referred for Primary PCI.NCT02978040	Phase 4	Completed	Insel Gruppe AG, University Hospital Bern	122	2017-07-04 → 2019-12-27
Cangrelor to Clopidogrel or Prasugrel Transition Study NCT01979445	Phase 2	Completed	The Medicines Company	15	2013-12-02 → 2014-01-20

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$6264.54

Highest Price

$6264.54

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
10122-0620-10KENGREAL 50MG/10ML	$6264.54	FSS	Chiesi USA, Inc.	09/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain3 active DMFs

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

VERANOVA LPCANGRELOR

DMF 184352005

OLON SPACANGRELOR TETRASODIUM

DMF 332952018

MSN LIFE SCIENCES PRIVATE LTDCANGRELOR TETRA SODIUM

DMF 333172018

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jan 27, 2023	SUPPL -3	View Letter (PDF)
Oct 24, 2019	SUPPL -2	View Letter (PDF)
Jun 22, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/VIAL

RLDAP

7 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jun 22, 2015

Patents (7) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8680052	Mar 9, 2033	—	—	—		—
9295687	Jul 10, 2035	—	—	Yes	—	—
9427448	Nov 10, 2030	—	—	—		—
9439921	Jul 10, 2035	—	—	Yes	—	—
9700575	Jul 10, 2035	—	—	Yes	—	—
9925265	May 13, 2029	—	—	—		—
10039780	Jul 10, 2035	—	—	—		—