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GAVRETO

NDA

PRALSETINIB | N213721 | RIGEL PHARMACEUTICALS INC

1 strength7 unique patents3 unique exclusivities

Patent Timeline

7 unique patents, 3 exclusivities by expiration date

Active (7)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Nov. 1, 2036

Apr. 3, 2039

Apr. 3, 2039

Apr. 3, 2039

Jul. 7, 2042

Apr. 3, 2039

Nov. 1, 2036

ODE-318

Sep. 4, 2027

ODE-340

Dec. 1, 2027

ODE-341

Dec. 1, 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

5 trials from ClinicalTrials.gov — 2 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)NCT04302025	Phase 2	Recruiting	Genentech, Inc.	99	2020-11-06 → 2030-05-30
Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation NCT04322890	Phase 2	Recruiting	Hunan Province Tumor Hospital	6,000	2020-04-16 → 2027-12-24
Pre-Approval Access Program (PAAP) for Pralsetinib (BLU-667) in Patients With Unresectable or Metastatic NSCLC or MTC NCT04204928	—	APPROVED_FOR_MARKETING	Blueprint Medicines Corporation	—	—
Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors NCT03037385	Phase 1/2	Completed	Hoffmann-La Roche	590	2017-03-17 → 2024-03-21
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)NCT04222972	Phase 3	Terminated	Hoffmann-La Roche	223	2020-07-24 → 2025-01-27

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$8272.28

Highest Price

$16095.10

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
71332-0006-60GAVRETO 100MG CAP,ORAL	$10730.08	FSS	Rigel Pharmaceuticals, Inc.	10/14/2028
71332-0006-60GAVRETO 100MG CAP,ORAL	$8272.28	Big4	Rigel Pharmaceuticals, Inc.	10/14/2028
71332-0006-90GAVRETO 100MG CAP,ORAL	$16095.10	FSS	Rigel Pharmaceuticals, Inc.	10/14/2028
71332-0006-90GAVRETO 100MG CAP,ORAL	$12544.63	Big4	Rigel Pharmaceuticals, Inc.	10/14/2028
50242-0210-60GAVRETO 100MG CAP,ORAL	$10453.88	FSS	Genentech USA, Inc.	09/14/2028
50242-0210-60GAVRETO 100MG CAP,ORAL	$8377.68	Big4	Genentech USA, Inc.	09/14/2028
50242-0210-90GAVRETO 100MG CAP,ORAL	$15680.79	FSS	Genentech USA, Inc.	09/14/2028
50242-0210-90GAVRETO 100MG CAP,ORAL	$12560.78	Big4	Genentech USA, Inc.	09/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Gavreto (2024)

Total Spending

$14.9M

Total Claims

980

Beneficiaries

159

Avg Cost/Unit

$182.00

Spending Trend

$2.6M(2021)→$8.4M(2022)→$11.0M(2023)→$14.9M(2024)

YoY Change:-2.5%

5yr CAGR:+3.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain2 active DMFs

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

OLON SPAPRALSETINIB

DMF 396592024

VALARY LAB PRIVATE LIMITEDPRALSETINIB

DMF 398142024

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Dec 23, 2025	SUPPL -16	View Letter (PDF)
Mar 25, 2024	SUPPL -15	View Letter (PDF)
Aug 10, 2023	SUPPL -9	View Letter (PDF)
Jul 21, 2023	SUPPL -14	View Letter (PDF)
Jul 3, 2023	SUPPL -11	View Letter (PDF)
Feb 3, 2022	SUPPL -5	View Letter (PDF)
Nov 12, 2021	SUPPL -4	View Letter (PDF)
Sep 8, 2020	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

RLD

7 patents3 exclusivities▴

CAPSULE;ORAL | Approved: Sep 4, 2020

Patents (7) · 6 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10030005	Nov 1, 2036	—	Yes	Yes		—
11273160	Apr 3, 2039	—	—	—		—
11872192	Apr 3, 2039	—	—	—		—
11963958	Apr 3, 2039	—	—	—		—
12448366	Jul 7, 2042	—	Yes	—	—	—
12539303	Apr 3, 2039	—	—	—		—
12655128Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Nov 1, 2036	—	Yes	Yes	—	—

Exclusivities (3)

Code	Date	Status
ODE-318	Sep 4, 2027	Active
ODE-340	Dec 1, 2027	Active
ODE-341	Dec 1, 2027	Active