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
Generic Entry Date for asciminib hydrochloride*:
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.
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 | 215358-002 | Oct 29, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | SCEMBLIX | asciminib hydrochloride | TABLET;ORAL | 215358-001 | Oct 29, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | SCEMBLIX | asciminib hydrochloride | TABLET;ORAL | 215358-001 | Oct 29, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | SCEMBLIX | asciminib hydrochloride | TABLET;ORAL | 215358-002 | Oct 29, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 asciminib hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| France | 22C1053 | ⤷ Try a Trial | |
| Canada | 2871715 | DERIVES DE BENZAMIDE POUR INHIBER L'ACTIVITE D'ABL1, D'ABL2 ET DE BCR-ABL2 (BENZAMIDE DERIVATIVES FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1) | ⤷ Try a Trial |
| Taiwan | 202110823 | Crystalline forms of N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide | ⤷ Try a Trial |
| China | 114144232 | N-[4-(氯二氟甲氧基)苯基]-6-[(3R)-3-羟基吡咯烷-1-基]-5-(1H-吡唑-5-基)吡啶-3-甲酰胺的结晶形式 (Crystalline forms of n-[4-(chlorodifluoromethoxy) phenyl]-6-[(3r)-3-hydroxypyrrolidin-1-yl]-5-(1h-pyrazol-5-yl) pyridine-3-carboxamide) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for asciminib hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2861579 | C20220039 00385 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ASTSIMINIIB;REG NO/DATE: EU/1/22/1670 26.08.2022 |
| 2861579 | CR 2022 00046 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ASCIMINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SASOM ASCIMINIB HYDROKLORID; REG. NO/DATE: EU/1/22/1670 20220826 |
| 2861579 | 2022C/548 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ASCIMINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, ZOALS ASCIMINIB HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1670 20220826 |
| 2861579 | 2290039-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ASCIMINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, SUCH AS ASCIMINIB HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1670 20220826 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
