KENGREAL Drug Patent Profile
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When do Kengreal patents expire, and what generic alternatives are available?
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
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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 |
| 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
*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 |
|---|---|
| Scott R MacKenzie Foundation | Phase 4 |
| University of Florida | 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 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods of treating, reducing the incidence of, and/or preventing ischemic events
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods of treating or preventing stent thrombosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ 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 | ||||
| >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 | ⤷ 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 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
Patent: formulações farmacêuticas e recipientes selados
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 71868
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 17001840
Patent: Formulaciones farmacéuticas que comprenden cangrelor de alta pureza y métodos para preparar y usar las mismas.
Estimated Expiration: ⤷ Sign Up
China
Patent: 7206014
Patent: 包含高纯度坎格雷洛的药物制剂以及制备和使用它们的方法 (Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same)
Estimated Expiration: ⤷ Sign Up
Patent: 5990138
Patent: 包含高纯度坎格雷洛的药物制剂以及制备和使用它们的方法 (Pharmaceutical formulations comprising high purity cangrelor and methods of making and using same)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 17006958
Patent: Formulaciones farmacéuticas que comprenden cangrelor de alta pureza y métodos para la preparación y uso de los mismos
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 44900
Patent: FORMULATIONS PHARMACEUTIQUES COMPRENANT DU CANGRELOR DE HAUTE PURETÉ ET LEURS PROCÉDÉS DE PRÉPARATION ET D'UTILISATION (PHARMACEUTICAL FORMULATIONS COMPRISING HIGH PURITY CANGRELOR AND METHODS FOR PREPARING AND USING THE SAME)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 17009289
Patent: FORMULACIONES FARMACEUTICAS QUE COMPRENDEN CANGRELOR DE ALTA PUREZA Y METODOS PARA PREPARAR Y UTILIZAR LAS MISMAS. (PHARMACEUTICAL FORMULATIONS COMPRISING HIGH PURITY CANGRELOR AND METHODS FOR PREPARING AND USING THE SAME.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 326
Patent: FORMULATIONS PHARMACEUTIQUES COMPRENANT DU CANGRELOR DE HAUTE PURETÉ ET LEURS PROCÉDÉS DE PRÉPARATION ET D'UTILISATION
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 171246
Patent: FORMULACIONES FARMACEUTICAS QUE COMPRENDEN CANGRELOR DE ALTA PUREZA Y METODOS PARA LA PREPARACION Y USO DE LOS MISMOS
Estimated Expiration: ⤷ Sign Up
Patent: 221170
Patent: FORMULACIONES FARMACEUTICAS QUE COMPRENDEN CANGRELOR DE ALTA PUREZA Y METODOS PARA LA PREPARACION Y USO DE LOS MISMOS
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 33409
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Patent: 17127531
Patent: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, ВКЛЮЧАЮЩИЕ КАНГРЕЛОР ВЫСОКОЙ ЧИСТОТЫ, И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2440847
Estimated Expiration: ⤷ Sign Up
Patent: 170103848
Patent: 고순도의 칸그렐러를 포함하는 약제학적 제제, 및 이들의 제조 및 사용 방법
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Malaysia | 116421 | NEW FORMULATION | ⤷ Sign Up |
| Australia | 2012295343 | Maintenance of platelet inhibition during antiplatelet therapy | ⤷ Sign Up |
| 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 |
| >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 | ⤷ 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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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.
ISSN: 2162-2639
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