Cangrelor - Generic Drug Details

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What are the generic drug sources for cangrelor and what is the scope of freedom to operate?

Cangrelor is the generic ingredient in one branded drug marketed by Chiesi and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cangrelor has seventy-three patent family members in twenty-four countries.

There are three drug master file entries for cangrelor. One supplier is listed for this compound.

Summary for cangrelor

International Patents:	73
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	30
Patent Applications:	1,088
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cangrelor
What excipients (inactive ingredients) are in cangrelor?	cangrelor excipients list
DailyMed Link:	cangrelor at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cangrelor

Generic Entry Date for cangrelor^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for cangrelor

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Federico II University	Phase 4
Mercy Health Ohio	Phase 3
Fondation Ophtalmologique Adolphe de Rothschild	Phase 3

See all cangrelor clinical trials

Pharmacology for cangrelor

Drug Class	P2Y12 Platelet Inhibitor
Mechanism of Action	P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Anatomical Therapeutic Chemical (ATC) Classes for cangrelor

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for CANGRELOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KENGREAL	For Injection	cangrelor	50 mg/vial	204958	2	2019-06-24

US Patents and Regulatory Information for cangrelor

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for cangrelor

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	⤷ Sign Up	⤷ Sign Up
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for cangrelor

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Chiesi Farmaceutici S.p.A.	Kengrexal	cangrelor	EMEA/H/C/003773 Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.	Authorised	no	no	no	2015-03-23
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for cangrelor

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2733409	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, ВКЛЮЧАЮЩИЕ КАНГРЕЛОР ВЫСОКОЙ ЧИСТОТЫ, И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (PHARMACEUTICAL COMPOSITIONS CONTAINING HIGH-PURITY CANGRELOR, AND METHODS FOR PRODUCTION AND USE THEREOF)	⤷ Sign Up
Hungary	E031704		⤷ Sign Up
Australia	2010319612	Methods of treating or preventing stent thrombosis	⤷ Sign Up
Poland	2276541		⤷ Sign Up
Canada	2904523	METHODES PERMETTANT DE TRAITER DES EVENEMENTS ISCHEMIQUES, DE REDUIRE LEUR INCIDENCE ET/OU DE LES PREVENIR (METHODS OF TREATING, REDUCING THE INCIDENCE OF, AND/OR PREVENTING ISCHEMIC EVENTS)	⤷ Sign Up
Canada	2971868	FORMULATIONS PHARMACEUTIQUES COMPRENANT DU CANGRELOR DE HAUTE PURETE ET LEURS PROCEDES DE PREPARATION ET D'UTILISATION (PHARMACEUTICAL FORMULATIONS COMPRISING HIGH PURITY CANGRELOR AND METHODS FOR PREPARING AND USING THE SAME)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for cangrelor

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1007094	15C0060	France	⤷ Sign Up	PRODUCT NAME: CANGRELOR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,NOTAMMENT UN SEL TETRASODIQUE; REGISTRATION NO/DATE: EU/1/15/994/001 20150323
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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