Viewing data from:

SCEMBLIX

NDA

ASCIMINIB HYDROCHLORIDE | N215358 | NOVARTIS PHARMACEUTICALS CORP

3 strengths4 unique patents9 unique exclusivities

Patent Timeline

4 unique patents, 9 exclusivities by expiration date

Active (4)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

Oct. 29, 2035

May. 14, 2040

May. 14, 2040

May. 17, 2040

NCE

Oct. 29, 2026

I-953

Oct. 29, 2027

I-954

Oct. 29, 2027

M-318

Oct. 2, 2028

ODE-381

Oct. 29, 2028

ODE-382

Oct. 29, 2028

ODE*

Oct. 29, 2028

ODE-499

Oct. 29, 2031

ODE-500

Oct. 29, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Scemblix (2023)

Total Spending

$114.5M

Total Claims

4,397

Beneficiaries

704

Avg Cost/Unit

$350.22

Spending Trend

$2.1M(2021)→$52.5M(2022)→$114.5M(2023)

YoY Change:+9.9%

5yr CAGR:+6.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

BIOPHORE INDIA PHARMACEUTICALS PVT LTDASCIMINIB HYDROCHLORIDE PREMIX

DMF 410142024

BIOPHORE INDIA PHARMACEUTICALS PVT LTDASCIMINIB HYDROCHLORIDE PREMIX-I

DMF 413932025

MSN LABORATORIES PRIVATE LTDASCIMINIB HYDROCHLORIDE

DMF 422602025

HETERO LABS LTDASCIMINIB HYDROCHLORIDE PREMIX

DMF 422982025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Nov 28, 2025	SUPPL -12	View Letter (PDF)
Nov 28, 2025	SUPPL -12	View Letter (PDF)
Oct 3, 2025	SUPPL -10	View Letter (PDF)
Oct 30, 2024	SUPPL -8	View Letter (PDF)
Oct 30, 2024	SUPPL -9	View Letter (PDF)
Aug 9, 2024	SUPPL -7	View Letter (PDF)
Nov 13, 2023	SUPPL -4	View Letter (PDF)
Jun 27, 2023	SUPPL -3	View Letter (PDF)
Oct 13, 2022	SUPPL -1	View Letter (PDF)
Nov 1, 2021	ORIG -1	View Letter (PDF)
Nov 1, 2021	ORIG -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 20MG BASE

RLD

4 patents8 exclusivities▴

TABLET;ORAL | Approved: Oct 29, 2021

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8829195	Oct 29, 2035	—	Yes	—		—
11407735	May 14, 2040	—	Yes	—	—	—
12252478	May 14, 2040	—	—	Yes	—	—
12252479	May 17, 2040	—	—	—		—

Exclusivities (8)

Code	Date	Status
I-953	Oct 29, 2027	Active
I-954	Oct 29, 2027	Active
M-318	Oct 2, 2028	Active
NCE	Oct 29, 2026	< 1 year
ODE-381	Oct 29, 2028	Active
ODE-382	Oct 29, 2028	Active
ODE-499	Oct 29, 2031	Active
ODE-500	Oct 29, 2031	Active

#002 — EQ 40MG BASE

RLD

4 patents8 exclusivities▾

TABLET;ORAL | Approved: Oct 29, 2021

#003 — EQ 100MG BASE

RLD

4 patents3 exclusivities▾

TABLET;ORAL | Approved: Apr 18, 2024