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 seven patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-three patent family members in twenty-four 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
Summary for KENGREAL
International Patents: | 73 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 36 |
Clinical Trials: | 6 |
Patent Applications: | 518 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for KENGREAL |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KENGREAL |
What excipients (inactive ingredients) are in KENGREAL? | KENGREAL excipients list |
DailyMed Link: | KENGREAL at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Sponsor | Phase |
---|---|
University of Florida | Phase 4 |
Scott R. MacKenzie Foundation | Phase 4 |
Scott R MacKenzie Foundation | Phase 4 |
Pharmacology for KENGREAL
Drug Class | P2Y12 Platelet Inhibitor |
Mechanism of Action | P2Y12 Receptor Antagonists |
Physiological Effect | Decreased Platelet Aggregation |
Anatomical Therapeutic Chemical (ATC) Classes for KENGREAL
US Patents and Regulatory Information for KENGREAL
KENGREAL is protected by seven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of KENGREAL is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Methods of treating, reducing the incidence of, and/or preventing ischemic events
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods of treating, reducing the incidence of, and/or preventing ischemic events
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods of treating or preventing stent thrombosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Chiesi | KENGREAL | cangrelor | POWDER;INTRAVENOUS | 204958-001 | Jun 22, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Chiesi | KENGREAL | cangrelor | POWDER;INTRAVENOUS | 204958-001 | Jun 22, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 KENGREAL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Chiesi | KENGREAL | cangrelor | POWDER;INTRAVENOUS | 204958-001 | Jun 22, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Chiesi | KENGREAL | cangrelor | POWDER;INTRAVENOUS | 204958-001 | Jun 22, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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: ⤷ Try a Trial
Canada
Patent: 71868
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 17001840
Estimated Expiration: ⤷ Try a Trial
China
Patent: 7206014
Estimated Expiration: ⤷ Try a Trial
Patent: 5990138
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 17006958
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 44900
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17009289
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 326
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 171246
Estimated Expiration: ⤷ Try a Trial
Patent: 221170
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 33409
Estimated Expiration: ⤷ Try a Trial
Patent: 17127531
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2440847
Estimated Expiration: ⤷ Try a Trial
Patent: 170103848
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2009140407 | ⤷ Try a Trial | |
Brazil | 112012011298 | métodos de tratar ou previnir trombose de stent | ⤷ Try a Trial |
Denmark | 1007094 | ⤷ Try a Trial | |
>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 | ⤷ Try a Trial | 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 |