SCEMBLIX Drug Patent Profile
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Which patents cover Scemblix, and when can generic versions of Scemblix launch?
Scemblix is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug.
This drug has eighty-four patent family members in forty-nine countries.
The generic ingredient in SCEMBLIX is asciminib hydrochloride. One supplier is listed for this compound. Additional details are available on the asciminib hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Scemblix
Scemblix will be eligible for patent challenges on October 29, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 14, 2040. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for SCEMBLIX
International Patents: | 84 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Patent Applications: | 1 |
Drug Prices: | Drug price information for SCEMBLIX |
What excipients (inactive ingredients) are in SCEMBLIX? | SCEMBLIX excipients list |
DailyMed Link: | SCEMBLIX at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SCEMBLIX
Generic Entry Date for SCEMBLIX*:
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.
Anatomical Therapeutic Chemical (ATC) Classes for SCEMBLIX
US Patents and Regulatory Information for SCEMBLIX
SCEMBLIX is protected by two US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SCEMBLIX is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting SCEMBLIX
Crystalline forms of N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(- 1H-pyrazol-5-yl)pyridine-3-carboxamide
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds and compositions for inhibiting the activity of ABL1, ABL2 and BCR-ABL1
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML)
FDA Regulatory Exclusivity protecting SCEMBLIX
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) IN CHRONIC PHASE (CP), PREVIOUSLY TREATED WITH TWO OR MORE TYROSINE KINASE INHIBITORS (TKIS)
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) IN CHRONIC PHASE (CP) WITH THE T315I MUTATION
Exclusivity Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | 215358-002 | 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 | ⤷ 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 SCEMBLIX
When does loss-of-exclusivity occur for SCEMBLIX?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 20276701
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2021022712
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 39812
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 21003011
Estimated Expiration: ⤷ Try a Trial
China
Patent: 4144232
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 69117
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 7995
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 22532404
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 21013970
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 220009414
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 2110823
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering SCEMBLIX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Peru | 20150669 | DERIVADOS DE BENZAMIDA PARA LA INHIBICION DE LA ACTIVIDAD DE ABL1, ABL2 Y BCR-ABL1 | ⤷ Try a Trial |
China | 104302638 | Benzamide derivatives for inhibiting the activity of abl1, abl2 and bcr-abl1 | ⤷ Try a Trial |
Jordan | 3453 | مشتقات البنزاميد لتثبيط نشاط abl1 و abl2 و bcr-abl1 (Benzamide Derivatives FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1) | ⤷ Try a Trial |
Australia | 2013261130 | Benzamide derivatives for inhibiting the activity of ABL1, ABL2 and BCR-ABL1 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SCEMBLIX
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 | 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 |
2861579 | 301201 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ASCIMINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS ASCIMINIBHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1670 20220826 |
2861579 | 45/2022 | Austria | ⤷ Try a Trial | 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 |