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TABRECTA

NDA

CAPMATINIB HYDROCHLORIDE | N213591 | NOVARTIS PHARMACEUTICAL CORP

2 strengths7 unique patents1 unique exclusivity

Patent Timeline

7 unique patents, 1 exclusivity by expiration date

Active (7)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Nov. 19, 2032

Jun. 5, 2031

Nov. 19, 2027

May. 20, 2029

Jul. 22, 2035

Nov. 19, 2027

Jul. 22, 2035

ODE-291

May. 6, 2027

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 Tabrecta (2023)

Total Spending

$93.1M

Total Claims

4,864

Beneficiaries

978

Avg Cost/Unit

$200.46

Spending Trend

$17.1M(2020)→$50.1M(2021)→$70.3M(2022)→$93.1M(2023)

YoY Change:+8.6%

5yr CAGR:+6.9%

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

NATCO PHARMA LTDCAPMATINIB HYDROCHLORIDE

DMF 396442024

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Mar 15, 2024	SUPPL -11	View Letter (PDF)
Mar 27, 2023	SUPPL -7	View Letter (PDF)
Aug 11, 2022	SUPPL -4	View Letter (PDF)
Jan 25, 2022	SUPPL -2	View Letter (PDF)
May 7, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 150MG BASE

RLD

7 patents1 exclusivity▴

TABLET;ORAL | Approved: May 6, 2020

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7767675	Nov 19, 2032	—	Yes	Yes	—	—
8420645	Jun 5, 2031	—	Yes	Yes	—	—
8461330	Nov 19, 2027	—	Yes	Yes	—	—
8901123	May 20, 2029	—	—	—		—
10596178	Jul 22, 2035	—	—	Yes	—	—
12084449	Nov 19, 2027	—	—	—		—
12208101	Jul 22, 2035	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
ODE-291	May 6, 2027	< 1 year

#002 — EQ 200MG BASE

RLD

7 patents1 exclusivity▾

TABLET;ORAL | Approved: May 6, 2020