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Harvard Business School
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Johnson and Johnson
Cantor Fitzgerald
Healthtrust
Baxter
US Department of Justice
Fuji
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Generated: December 12, 2018

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KISQALI Drug Profile

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When do Kisqali patents expire, and when can generic versions of Kisqali launch?

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
Drug patent expirations by year for KISQALI
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
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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for KISQALI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017039 Lithuania ➤ Sign Up PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2017 00060 Denmark ➤ Sign Up PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824
0909 Netherlands ➤ Sign Up PRODUCT NAME: RIBOCICLIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2017000102 Germany ➤ Sign Up PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
QuintilesIMS
Cerilliant
Healthtrust
Dow
Teva
Daiichi Sankyo
Johnson and Johnson
Argus Health

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