Asciminib hydrochloride - Generic Drug Details
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What are the generic drug sources for asciminib hydrochloride and what is the scope of freedom to operate?
Asciminib hydrochloride
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Asciminib hydrochloride has eighty-four patent family members in forty-nine countries.
One supplier is listed for this compound.
Summary for asciminib hydrochloride
| International Patents: | 84 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 16 |
| Patent Applications: | 2 |
| DailyMed Link: | asciminib hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for asciminib hydrochloride
*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 asciminib hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sarit Assouline | Phase 3 |
| Novartis | Phase 3 |
| Augusta University | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for asciminib hydrochloride
US Patents and Regulatory Information for asciminib hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | SCEMBLIX | asciminib hydrochloride | TABLET;ORAL | 215358-001 | Oct 29, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | SCEMBLIX | asciminib hydrochloride | TABLET;ORAL | 215358-002 | Oct 29, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | SCEMBLIX | asciminib hydrochloride | TABLET;ORAL | 215358-001 | Oct 29, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | SCEMBLIX | asciminib hydrochloride | TABLET;ORAL | 215358-002 | Oct 29, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | SCEMBLIX | asciminib hydrochloride | TABLET;ORAL | 215358-002 | Oct 29, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 asciminib hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Colombia | 7131380 | Derivados de benzamida para la inhibición de la actividad de abl1, abl2 y bcr-abl1 | ⤷ Sign Up |
| Brazil | 112021022712 | Formas cristalinas de n-[4-(clorodifluorometóxi)fenil]-6-[(3r)-3-hidroxipirrolidin-1-il]-5-(1h-pirazol-5-il)piridina-3-carboxamida | ⤷ Sign Up |
| Australia | 2013261130 | Benzamide derivatives for inhibiting the activity of ABL1, ABL2 and BCR-ABL1 | ⤷ Sign Up |
| European Patent Office | 3969117 | FORMES CRISTALLINES DE N-[4- (CHLORODIFLUOROMÉTHOXY) PHÉNYL]-6-[(3R)-3-HYDROXYPYRROLIDIN-1-YL]-5-(1H-PYRAZOL-5-YL)PYRIDINE-3-CARBOXAMIDE (CRYSTALLINE FORMS OF N-[4-(CHLORODIFLUOROMETHOXY)PHENYL]-6-[(3R)-3-HYDROXYPYRROLIDIN-1-YL]-5-(1H-PYRAZOL-5-YL)PYRIDINE-3-CARBOXAMIDE) | ⤷ Sign Up |
| Philippines | 12014502531 | BENZAMINE DERIVATIVES FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1 | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for asciminib hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2861579 | 2022C/548 | Belgium | ⤷ Sign Up | PRODUCT NAME: ASCIMINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, ZOALS ASCIMINIB HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1670 20220826 |
| 2861579 | 22C1053 | France | ⤷ Sign Up | PRODUCT NAME: ASCIMINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TEL QUE LE CHLORHYDRATE D'ASCIMINIB; REGISTRATION NO/DATE: EU/1/22/1670 20220826 |
| 2861579 | PA2022523 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ASCIMINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, TOKIA KAIP ASCIMINIBO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/22/1670 20220825 |
| 2861579 | C202230056 | Spain | ⤷ Sign Up | PRODUCT NAME: ASCIMINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, TAL COMO HIDROCLORURO DE ASCIMINIB; NATIONAL AUTHORISATION NUMBER: EU/1/22/1670; DATE OF AUTHORISATION: 20220825; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1670; DATE OF FIRST AUTHORISATION IN EEA: 20220825 |
| 2861579 | 45/2022 | Austria | ⤷ Sign Up | PRODUCT NAME: ASCIMINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, WIE ASCIMINIB-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1670 (MITTEILUNG) 20220826 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
