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Last Updated: October 24, 2020

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KENGREAL Drug 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.

This drug has one hundred and six patent family members in forty-one 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.

US ANDA Litigation and 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 two 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

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Generic Entry Opportunity Date for KENGREAL
Generic Entry Date for KENGREAL*:
Constraining patent/regulatory exclusivity:

*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

National University Hospital, SingaporePhase 2
Tan Tock Seng HospitalPhase 2
Khoo Teck Puat HospitalPhase 2

See all KENGREAL clinical trials

Pharmacology for KENGREAL
Paragraph IV (Patent) Challenges for KENGREAL
Tradename Dosage Ingredient NDA Submissiondate
KENGREAL POWDER;INTRAVENOUS cangrelor 204958 2019-06-24

US Patents and Regulatory Information for KENGREAL

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

Supplementary Protection Certificates for KENGREAL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

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