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scemblix Drug Patent Profile

Which patents cover Scemblix, and what generic alternatives are available?

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

See drug prices for scemblix

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for scemblix

NDA:

215358

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.

US Patents and Regulatory Information for scemblix

scemblix is protected by two US patents and four FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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				Y
Novartis	SCEMBLIX	asciminib hydrochloride	TABLET;ORAL	215358-002	Oct 29, 2021		RX	Yes	Yes				Y
Novartis	SCEMBLIX	asciminib hydrochloride	TABLET;ORAL	215358-001	Oct 29, 2021		RX	Yes	No
Novartis	SCEMBLIX	asciminib hydrochloride	TABLET;ORAL	215358-003	Apr 18, 2024		RX	Yes	No				Y
Novartis	SCEMBLIX	asciminib hydrochloride	TABLET;ORAL	215358-002	Oct 29, 2021		RX	Yes	Yes
Novartis	SCEMBLIX	asciminib hydrochloride	TABLET;ORAL	215358-003	Apr 18, 2024		RX	Yes	No
Novartis	SCEMBLIX	asciminib hydrochloride	TABLET;ORAL	215358-001	Oct 29, 2021		RX	Yes	No				Y

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

Brazil

Canada

Chile

China

European Patent Office

Israel

Japan

Mexico

South Korea

Taiwan

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
Cuba	24265	COMPUESTOS DERIVADOS DE BENZAMIDA PARA INHIBIR LA ACTIVIDAD DE ABL1, ABL2 Y BCR-ABL1, ÚTILES EN EL TRATAMIENTO DEL CÁNCER
Montenegro	03095	DERIVATI BENZAMIDA ZA INHIBIRANJE AKTIVNOSTI ABL1, ABL2 I BCR-ABL1 (BENZAMIDE DERIVATIVES FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1)
Serbia	57177	DERIVATI BENZAMIDA ZA INHIBIRANJE AKTIVNOSTI ABL1, ABL2 I BCR-ABL1 (BENZAMIDE DERIVATIVES FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1)
Costa Rica	20140519	DERIVADOS DE BENZAMIDA PARA LA INHIBICIÓN DE LA ACTIVIDAD DE ABL 1, ABL 2 Y BCR-ABL 1
Ukraine	113208	ПОХІДНІ БЕНЗАМІДУ ДЛЯ ІНГІБУВАННЯ АКТИВНОСТІ ABL1, ABL2 ТА BCR-ABL1
France	22C1053
Poland	2861579

Supplementary Protection Certificates for scemblix

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2861579	301201	Netherlands		PRODUCT NAME: ASCIMINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS ASCIMINIBHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1670 20220826
2861579	2290039-3	Sweden		PRODUCT NAME: ASCIMINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, SUCH AS ASCIMINIB HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1670 20220826
2861579	2022C/548	Belgium		PRODUCT NAME: ASCIMINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, ZOALS ASCIMINIB HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1670 20220826
2861579	C20220039 00385	Estonia		PRODUCT NAME: ASTSIMINIIB;REG NO/DATE: EU/1/22/1670 26.08.2022
2861579	CR 2022 00046	Denmark		PRODUCT NAME: ASCIMINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SASOM ASCIMINIB HYDROKLORID; REG. NO/DATE: EU/1/22/1670 20220826
2861579	PA2022523	Lithuania		PRODUCT NAME: ASCIMINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, TOKIA KAIP ASCIMINIBO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/22/1670 20220825
2861579	C02861579/01	Switzerland		PRODUCT NAME: ASCIMINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68441 09.06.2022

Scemblix Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Scemblix

Introduction to Scemblix

Scemblix, a tyrosine kinase inhibitor developed by Novartis, has recently garnered significant attention in the pharmaceutical industry due to its approval for the treatment of newly diagnosed chronic myeloid leukemia (CML). Here, we delve into the market dynamics and financial trajectory of this promising drug.

FDA Approval and Expanded Indication

Scemblix was granted accelerated approval by the FDA for the treatment of adults with newly diagnosed Philadelphia chromosome-positive CML in the chronic phase. This approval marks a significant expansion of the drug's indication, increasing the eligible patient population by approximately four times[1][3][5].

Clinical Efficacy

The FDA approval was backed by data from the Phase III ASC4FIRST trial, which demonstrated Scemblix's superior efficacy compared to standard-of-care tyrosine kinase inhibitors (TKIs) such as imatinib and nilotinib. The trial showed that 68% of patients on Scemblix achieved a major molecular response (MMR) at week 48, compared to 49% of those treated with standard TKIs. Additionally, Scemblix exhibited a favorable safety and tolerability profile, with fewer treatment-related adverse events and lower discontinuation rates[1][3][4].

Market Impact

The approval of Scemblix as a first-line treatment for CML is expected to significantly impact the market. Given its superior efficacy and better safety profile, Scemblix is poised to become a new standard of care for CML patients. This shift could lead to a reduction in the use of older TKIs, such as Gleevec, and second-generation TKIs like nilotinib and dasatinib[4].

Financial Projections

Novartis has high expectations for Scemblix's financial performance. During the company's second-quarter earnings call, CEO Vas Narasimhan projected peak sales of over $3 billion for Scemblix. This projection is supported by the drug's strong performance in the third quarter, where Scemblix sales surged 72% year-over-year, reaching $182 million and beating analyst consensus by 3%[1].

Sales Growth Drivers

Scemblix is one of the key growth drivers for Novartis, contributing significantly to the company's overall sales growth. In the second quarter, Novartis reported an 11% increase in net sales, with volume contributing 15 percentage points to this growth. The strong sales performance of Scemblix, along with other key products like Entresto and Kesimpta, has been instrumental in driving Novartis's financial success[2].

Competitive Landscape

The CML treatment market is highly competitive, with several established TKIs. However, Scemblix's unique profile, which combines high potency with a favorable safety and tolerability profile, positions it favorably against competitors. The drug's ability to target the ABL myristoyl pocket specifically reduces side effects and toxicity, making it an attractive option for patients and healthcare providers[4].

Patient and Healthcare Provider Preferences

The superior efficacy and safety profile of Scemblix are likely to influence patient and healthcare provider preferences. As noted by Victor Bulto, U.S. president of Novartis, "Despite many advances in the field, patients still need treatment options that are highly effective with a favorable tolerability profile to help enable them to achieve meaningful outcomes." Scemblix's performance in clinical trials has exceeded expectations, with lead study author Timothy Hughes highlighting its potential to enable more patients to achieve treatment-free remission[1][4].

Regulatory and Market Access

Scemblix has been granted a breakthrough therapy designation for its first-line indication, which, combined with the FDA's real-time oncology review program, facilitated an expedited review process. This designation and the subsequent approval have paved the way for Scemblix to enter the market quickly and gain significant traction. Additionally, the drug is likely to be exempt from the Inflation Reduction Act’s drug price negotiations due to its focus on a rare disease[1][4].

Financial Performance and Cash Flow

Novartis's overall financial performance has been robust, with core net income increasing by 14% and core EPS by 17% in the second quarter. The company's free cash flow from continuing operations also saw a significant increase, reaching $4.6 billion, driven by higher net cash flows from operating activities. Scemblix's strong sales contribution is expected to continue driving these positive financial metrics[2].

Future Outlook

Given its strong clinical data and favorable market dynamics, Scemblix is poised for continued growth. Analysts from Jefferies have projected a peak sales market of up to $5.9 billion in the best-case scenario, highlighting the drug's potential to dominate the CML treatment market. As Scemblix continues to gain traction and become a standard of care, it is likely to play a pivotal role in Novartis's financial success in the coming years[1][4].

Key Takeaways

• Expanded Indication: Scemblix's FDA approval for newly diagnosed CML patients significantly broadens its market reach.
• Superior Efficacy: Clinical trials have shown Scemblix to be more effective than standard TKIs with a better safety profile.
• Financial Projections: Peak sales are projected to exceed $3 billion, driven by strong initial sales performance.
• Market Impact: Scemblix is expected to become a new standard of care, potentially reducing the use of older TKIs.
• Regulatory Advantages: Breakthrough therapy designation and expedited review have facilitated quick market entry.

FAQs

Q: What is Scemblix, and how does it work? A: Scemblix is an orally available tyrosine kinase inhibitor that works by blocking the BCR-ABL1 fusion protein, a hallmark of certain leukemias.

Q: What was the outcome of the Phase III ASC4FIRST trial for Scemblix? A: The trial showed that 68% of patients on Scemblix achieved a major molecular response at week 48, compared to 49% of those treated with standard TKIs, with a favorable safety and tolerability profile.

Q: How does Scemblix's safety profile compare to other TKIs? A: Scemblix has fewer treatment-related adverse events, lower discontinuation rates, and fewer dose reductions compared to standard TKIs.

Q: What are the financial projections for Scemblix? A: Novartis projects peak sales of over $3 billion for Scemblix, with some analysts projecting up to $5.9 billion in the best-case scenario.

Q: Is Scemblix likely to be affected by the Inflation Reduction Act’s drug price negotiations? A: No, Scemblix is likely to be exempt from these negotiations due to its focus on a rare disease.

Sources

1. Biospace: Novartis Secures First-Line CML Expansion for Scemblix, Projects $3B in Peak Sales.
2. Globenewswire: Novartis continues to deliver strong sales growth and core margin expansion in Q2, raises FY 2024 bottom-line guidance.
3. Drug-Dev: Novartis Scemblix FDA Approved in Newly Diagnosed CML Offering Superior Efficacy, Favorable Safety & Tolerability Profile.
4. Biospace: ASCO24: Novartis Leukemia Drug Beats Older Drugs in Phase III Readout.
5. Globenewswire: Novartis Scemblix® FDA approved in newly diagnosed CML.