DrugPatentWatch Database Preview
KISQALI Drug Profile
When do Kisqali patents expire, and what generic alternatives are available?
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 thirty-seven patent family members in forty-nine 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.
Summary for KISQALI
| International Patents: | 137 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 62 |
| Clinical Trials: | 9 |
| Patent Applications: | 116 |
| 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 |
|---|---|
| Novartis Pharmaceuticals | Phase 2 |
| Novartis | Phase 3 |
| West German Study Group | Phase 3 |
Pharmacology for KISQALI
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Kinase Inhibitors Cytochrome P450 3A Inhibitors |
Synonyms for KISQALI
| 1211441-98-3 |
| 2513AH |
| 6-(1H-Indazol-6-yl)-N-[4-(4-morpholinyl)phenyl]-Imidazo[1,2-a]pyrazin-8-amine |
| 6ZZ |
| 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo [2,3-d]pyrimidine-6-carboxylic acid dimethylamide |
| 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide |
| 7-cyclopentyl-N,N-dimethyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide |
| 7-Cyclopentyl-N,N-dimethyl-2-(5-(piperazin-1-yl)pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide |
| 7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide |
| AC-30029 |
| ACN-040728 |
| AK174906 |
| AKOS025404915 |
| AKOS032949987 |
| AOB87725 |
| AS-10159 |
| AX8322700 |
| BC600363 |
| BCP08804 |
| BDBM148264 |
| CHEMBL3545110 |
| CS-1750 |
| D10883 |
| DB11730 |
| EX-A304 |
| example 74 [US8962630] |
| FT-0700117 |
| GTPL7383 |
| HMS3653N03 |
| HY-15777 |
| J-690066 |
| KB-308551 |
| KS-0000068T |
| LEE 011 |
| LEE-011 |
| LEE011 |
| LEE011A |
| MolPort-035-395-865 |
| NCGC00386317-10 |
| NVP-LEE011 |
| RHXHGRAEPCAFML-UHFFFAOYSA-N |
| Ribociclib |
| Ribociclib (LEE011) |
| Ribociclib (USAN/INN) |
| Ribociclib [USAN:INN] |
| Ribociclib, LEE011 |
| Ribociclib(LEE011) |
| s7440 |
| SB18480 |
| SCHEMBL302310 |
| SW220101-1 |
| SYN1213 |
| TK8ERE8P56 |
| Tube013 |
| UNII-TK8ERE8P56 |
| US8962630, 74 |
| ZINC72316335 |
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 | 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 | ||
| 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 | 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 |
|---|---|---|
| Japan | 2017057203 | Start Trial |
| China | 101594871 | Start Trial |
| European Patent Office | 2331547 | Start Trial |
| Taiwan | I549953 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for KISQALI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2331547 | C20170039 00245 | Estonia | Start Trial | PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017 |
| 2331547 | PA2017039,C2331547 | Lithuania | Start Trial | PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
| 2331547 | 2017C/052 | Belgium | Start Trial | PRODUCT NAME: KISQALI - RIBOCOCLIB; AUTHORISATION NUMBER AND 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 |
