DrugPatentWatch Database Preview
KISQALI Drug Profile
When do Kisqali patents expire, and what generic alternatives are available?
Kisqali is a drug marketed by Novartis Pharms Corp and is included in two NDAs. There are seven patents protecting this drug.
This drug has one hundred and twenty-three patent family members in forty-eight 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: | 123 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 2 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 55 |
Clinical Trials: | 6 |
Patent Applications: | 79 |
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.
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 |
ACN-040728 |
AK174906 |
AKOS025404915 |
AKOS032949987 |
AOB87725 |
AS-10159 |
AX8322700 |
BC600363 |
BDBM148264 |
CHEMBL3545110 |
CS-1750 |
D08MXP |
D10883 |
DB11730 |
EX-A304 |
example 74 [US8962630] |
FT-0700117 |
GTPL7383 |
HMS3653N03 |
HY-15777 |
J-690066 |
KB-308551 |
Kisqali (TN) |
KS-0000068T |
LEE 011 |
LEE-011 |
LEE011 |
LEE011A |
MFCD27976795 |
MolPort-035-395-865 |
NVP-LEE011 |
RHXHGRAEPCAFML-UHFFFAOYSA-N |
Ribociclib |
Ribociclib (LEE011) |
Ribociclib (USAN/INN) |
Ribociclib [USAN:INN] |
Ribociclib, LEE011 |
Ribociclib(LEE011) |
s7440 |
SCHEMBL302310 |
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 Pharms Corp | KISQALI | ribociclib succinate | TABLET;ORAL | 209092-001 | Mar 13, 2017 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | ||
Novartis Pharms Corp | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET, TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | ||
Novartis Pharms Corp | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET, TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
Novartis Pharms Corp | KISQALI | ribociclib succinate | TABLET;ORAL | 209092-001 | Mar 13, 2017 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free 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 | Document Number | Estimated Expiration |
---|---|---|
Japan | 2013091665 | ➤ Try a Free Trial |
Brazil | 112013010167 | ➤ Try a Free Trial |
Dominican Republic | P2011000057 | ➤ Try a Free Trial |
World Intellectual Property Organization (WIPO) | 2007140222 | ➤ Try a Free Trial |
Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for KISQALI
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|
2017039 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
2017000102 | Germany | ➤ Try a Free Trial | PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
0909 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: RIBOCICLIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/17/1221 20170824 |
2017 00060 | Denmark | ➤ Try a Free Trial | PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824 |
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |