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KISQALI Drug Profile
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» See Plans and PricingWhen do Kisqali patents expire, and when can generic versions of Kisqali launch?
Kisqali is a drug marketed by Novartis and is included in two NDAs. There are seven patents protecting this drug.
This drug has one hundred and forty patent family members in fifty countries.
The generic ingredient in KISQALI is letrozole; ribociclib succinate. There are twenty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the letrozole; ribociclib succinate profile page.
US ANDA Litigation and Generic Entry Outlook for Kisqali
Kisqali will be eligible for patent challenges on March 13, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 9, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for KISQALI
| International Patents: | 140 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 69 |
| Clinical Trials: | 11 |
| Patent Applications: | 119 |
| Drug Prices: | Drug price information for KISQALI |
| DailyMed Link: | KISQALI at DailyMed |
Generic Entry Opportunity Date for KISQALI
Generic Entry Date for KISQALI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*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 KISQALI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Taiwan University Hospital | Phase 1 |
| Novartis Pharmaceuticals | Phase 2 |
| Genomic Health®, Inc. | Phase 3 |
Pharmacology for KISQALI
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Kinase Inhibitors Cytochrome P450 3A Inhibitors |
US Patents and Regulatory Information for KISQALI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | KISQALI | ribociclib succinate | TABLET;ORAL | 209092-001 | Mar 13, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET, TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET, TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | KISQALI | ribociclib succinate | TABLET;ORAL | 209092-001 | Mar 13, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | KISQALI | ribociclib succinate | TABLET;ORAL | 209092-001 | Mar 13, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET, TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 |
International Patents for KISQALI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | I398252 | Start Trial |
| China | 103788100 | Start Trial |
| Mexico | 2011001879 | Start Trial |
| China | 101594871 | Start Trial |
| San Marino | AP200800069 | Start Trial |
| Japan | 5882371 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for KISQALI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2331547 | LUC00048 | Luxembourg | Start Trial | PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/171221 20170824 |
| 2331547 | C20170039 00245 | Estonia | Start Trial | PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017 |
| 2331547 | 122017000102 | Germany | Start Trial | PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
| 2331547 | 291 26-2017 | Slovakia | Start Trial | PRODUCT NAME: RIBOCIKLIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1221 20170824 |
| 2331547 | 17C1059 | France | Start Trial | PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1221 20170824 |
| 2331547 | C201730045 | Spain | Start Trial | PRODUCT NAME: RIBOCICLIB O UNA SAL DE ESTE FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/17/1221; DATE OF AUTHORISATION: 20170822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1221; DATE OF FIRST AUTHORISATION IN EEA: 20170822 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
