Pharsight

Kisqali is owned by Novartis.

Kisqali contains Ribociclib Succinate.

Kisqali has a total of 8 drug patents out of which 0 drug patents have expired.

Kisqali was authorised for market use on 13 March, 2017.

Kisqali is available in tablet;oral dosage forms.

Kisqali can be used as in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hr-positive, her2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy; in combination with fulvestrant for the treatment of postmenopausal women with hr-positive, her2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy; in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her-2)-negative advanced or metastatic breast cancer; in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men, for the treatment of hr-positive, her2-negative advanced or metastatic breast cancer; in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer, in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hr-positive, her2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy; in combination with fulvestrant for the treatment of postmenopausal women with hr-positive, her2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy; in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her-2)-negative advanced or metastatic breast cancer; in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer; in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men, for the treatment of hr-positive, her2-negative advanced or metastatic breast cancer, in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her-2)-negative advanced or metastatic breast cancer; in combination with fulvestrant for the treatment of postmenopausal women with hr-positive, her2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy; in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hr-positive, her2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy; in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer; in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men, for the treatment of hr-positive, her2-negative advanced or metastatic breast cancer.

The generics of Kisqali are possible to be released after 14 April, 2036.

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8324225	NOVARTIS	Pyrrolopyrimidine compounds and their uses	Jun, 2028 (5 years from now)
US8685980	NOVARTIS	Pyrrolopyrimidine compounds and their uses	May, 2030 (7 years from now)
US8415355	NOVARTIS	Pyrrolopyrimidine compounds and their uses	Mar, 2031 (7 years from now)
US9193732	NOVARTIS	Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-D]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof	Nov, 2031 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9416136	NOVARTIS	Pyrrolopyrimidine compounds and their uses	Aug, 2029 (6 years from now)
US8962630	NOVARTIS	Pyrrolopyrimidine compounds and their uses	Dec, 2029 (6 years from now)
US9868739	NOVARTIS	Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof	Nov, 2031 (8 years from now)
US10799506	NOVARTIS	Ribociclib tablet	Apr, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
New Patient Population (NPP)	Dec 10, 2024

Drugs and Companies using RIBOCICLIB SUCCINATE ingredient

Market Authorisation Date: 13 March, 2017

Treatment: In combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hr-positive, her2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy; In combination with fulvestrant for the treatment of postmenopausal women with hr-positive, her2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy; In combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her-2)-negative advanced or metastatic breast cancer; In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men, for the treatment of hr-positive, her2-negative advanced or metastatic breast cancer; In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer

Dosage: TABLET;ORAL