Ribociclib succinate - Generic Drug Details
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What are the generic sources for ribociclib succinate and what is the scope of freedom to operate?
Ribociclib succinate
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ribociclib succinate has one hundred and eighty-four patent family members in fifty-three countries.
One supplier is listed for this compound.
Summary for ribociclib succinate
International Patents: | 184 |
US Patents: | 9 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 51 |
Patent Applications: | 89 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ribociclib succinate |
DailyMed Link: | ribociclib succinate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ribociclib succinate
Generic Entry Date for ribociclib succinate*:
Constraining patent/regulatory exclusivity:
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 ribociclib succinate
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 3A Inhibitors Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ribociclib succinate
Paragraph IV (Patent) Challenges for RIBOCICLIB SUCCINATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
KISQALI | Tablets | ribociclib succinate | 200 mg | 209092 | 4 | 2021-03-15 |
US Patents and Regulatory Information for ribociclib succinate
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Novartis | KISQALI | ribociclib succinate | TABLET;ORAL | 209092-001 | Mar 13, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Novartis | KISQALI | ribociclib succinate | TABLET;ORAL | 209092-001 | Mar 13, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | 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 |
International Patents for ribociclib succinate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 113956257 | 一种细胞周期调节蛋白依赖性激酶抑制剂的盐及其制备方法 (Salt(s) of cell cycle regulatory protein dependent kinase inhibitor and methods of making thereof) | ⤷ Sign Up |
Georgia, Republic of | P20135785 | PYRROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS | ⤷ Sign Up |
Mexico | 370852 | SAL (ES) DE DIMETIL-AMIDA DEL ÁCIDO 7-CICLOPENTIL-2- (5-PIPERAZIN-1-IL-PIRIDIN-2-IL-AMINO) -7H-PIRROLO- [2, 3-D]-PIRIMIDIN-6-CARBOXÍLICO Y PROCESOS PARA SU ELABORACIÓN. (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.) | ⤷ Sign Up |
New Zealand | 591176 | PYRROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ribociclib succinate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2331547 | PA2017039 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822 |
2331547 | CR 2017 00060 | Denmark | ⤷ Sign Up | PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824 |
2331547 | 2017/060 | Ireland | ⤷ Sign Up | PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1221 20170824 |
2331547 | 2017C/052 | Belgium | ⤷ Sign Up | PRODUCT NAME: KISQALI - RIBOCOCLIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1221 20170824 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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