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Last Updated: September 27, 2022

KENGREAL Drug Patent Profile


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When do Kengreal patents expire, and when can generic versions of Kengreal launch?

Kengreal is a drug marketed by Chiesi and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fourteen patent family members in forty-three countries.

The generic ingredient in KENGREAL is cangrelor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cangrelor profile page.

DrugPatentWatch® Generic Entry Outlook for Kengreal

Kengreal was eligible for patent challenges on June 22, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 10, 2035. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for KENGREAL
Drug Prices for KENGREAL

See drug prices for KENGREAL

DrugPatentWatch® Estimated Generic Entry Opportunity Date for KENGREAL
Generic Entry Date for KENGREAL*:
Constraining patent/regulatory exclusivity:
NDA:
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 KENGREAL

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

SponsorPhase
Scott R MacKenzie FoundationPhase 4
University of FloridaPhase 4
Scott R. MacKenzie FoundationPhase 4

See all KENGREAL clinical trials

Pharmacology for KENGREAL
Paragraph IV (Patent) Challenges for KENGREAL
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 KENGREAL

KENGREAL is protected by eight US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KENGREAL is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting KENGREAL

Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF REDUCING THE RISK OF PERIPROCEDURAL MYOCARDIAL INFARCTION, AND STENT THROMBOSIS IN A PATIENT UNDERGOING PCI BY ADMINISTERING INTRAVENOUSLY 30 UG/KG BOLUS BEFORE PCI AND THEN A CONTINUOUS INFUSION

Formulation containing a nucleotide analogue
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: P2Y12 PLATELET INHIBITOR FOR USE AS ADJUNCT TO PERCUTANEOUS CORONARY INTERVENTION TO REDUCE RISK OF VARIOUS DISEASES/CONDITIONS IN PATIENTS NOT TREATED WITH A P2Y12 PLATELET INHIBITOR AND NOT GIVEN A GLYCOPROTEIN IIB/IIIA INHIBITOR

Methods of treating, reducing the incidence of, and/or preventing ischemic events
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD COMPRISING IV ADMINISTRATION OF CANGRELOR BEFORE PCI THEN CONTINUOUS INFUSION FOR AT LEAST 2 HOURS OR THE DURATION OF PCI AND, DURING OR AFTER CONTINUOUS INFUSION, ADMINISTRATION OF A LOADING DOSE OF TICAGRELOR, OR AN EQUIVALENT METHOD

Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating, reducing the incidence of, and/or preventing ischemic events
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING, REDUCING THE INCIDENCE OF, OR PREVENTING AN ISCHEMIC EVENT IN A PATIENT UNDERGOING PCI BY ADMINISTERING INTRAVENOUSLY 30 UG/KG BOLUS BEFORE PCI AND CONTINUOUS INFUSION OF 4 UG/KG/MIN FOR AT LEAST 2 HOURS OR THE DURATION OF THE PCI

Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating or preventing stent thrombosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF REDUCING THE RISK OF PERIPROCEDURAL MYOCARDIAL INFARCTION, AND STENT THROMBOSIS IN A PATIENT UNDERGOING PCI BY ADMINISTERING INTRAVENOUSLY 30 UG/KG BOLUS BEFORE PCI AND THEN A CONTINUOUS INFUSION

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

EU/EMA Drug Approvals for KENGREAL

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 KENGREAL

When does loss-of-exclusivity occur for KENGREAL?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Brazil

Patent: 2017014996
Estimated Expiration: See Plans and Pricing

Canada

Patent: 71868
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17001840
Estimated Expiration: See Plans and Pricing

China

Patent: 7206014
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 17006958
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 44900
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 17009289
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 326
Estimated Expiration: See Plans and Pricing

Peru

Patent: 171246
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 33409
Estimated Expiration: See Plans and Pricing

Patent: 17127531
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170103848
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KENGREAL around the world.

Country Patent Number Title Estimated Expiration
Spain 2904256 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009140407 See Plans and Pricing
South Africa 9711055 Pharmaceutical compositions for freeze drying See Plans and Pricing
Eurasian Patent Organization 028885 СПОСОБЫ ЛЕЧЕНИЯ ИЛИ ПРЕДОТВРАЩЕНИЯ ТРОМБОЗА СТЕНТА И ИНФАРКТА МИОКАРДА (ВАРИАНТЫ) (METHODS OF TREATING OR PREVENTING STENT THROMBOSIS AND MYOCARDIAL INFARCTION (EMBODIMENTS)) See Plans and Pricing
Spain 2273425 See Plans and Pricing
China 1121875 See Plans and Pricing
Russian Federation 2216330 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ НУКЛЕОТИДНЫЙ АНАЛОГ, И СПОСОБ ЕЕ ПРИГОТОВЛЕНИЯ (NUCLEOTIDE ANALOG-CONTAINING PHARMACEUTICAL COMPOSITION AND METHOD FOR IT PREPARING) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KENGREAL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1007094 15C0060 France See Plans and Pricing 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.