Details for New Drug Application (NDA): 204958
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NDA 204958 describes KENGREAL, which is a drug marketed by Chiesi and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the KENGREAL profile page.
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.
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.
Summary for 204958
| Tradename: | KENGREAL |
| Applicant: | Chiesi |
| Ingredient: | cangrelor |
| Patents: | 7 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204958
Generic Entry Date for 204958*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 204958
| Mechanism of Action | P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 204958
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KENGREAL | cangrelor | POWDER;INTRAVENOUS | 204958 | NDA | Chiesi USA, Inc. | 10122-620 | 10122-620-10 | 10 VIAL, SINGLE-USE in 1 CARTON (10122-620-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (10122-620-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 50MG/VIAL | ||||
| Approval Date: | Jun 22, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 10, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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 | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 9, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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 | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 10, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 204958
| 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 |
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