Viewing data from:

PEMAZYRE

NDA

PEMIGATINIB | N213736 | INCYTE CORP

3 strengths5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

Jan. 30, 2035

Apr. 17, 2034

May. 3, 2039

Aug. 30, 2040

Oct. 3, 2040

ODE-292

Apr. 17, 2027

ODE-404

Aug. 26, 2029

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

17 trials from ClinicalTrials.gov — 4 recruiting, 1 active, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas NCT06300528	Phase 2	Active	University of Utah	1	2025-10-03 → 2027-03
A Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma With FGFR2 Fusion or Rearrangements After at Least 1 Prior Line of Systemic Therapy NCT07862998	Phase 2	Not Yet Recruiting	Incyte Corporation	72	2026-12-15 → 2031-03-27
Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion NCT06439485	Phase 1/2	Recruiting	M.D. Anderson Cancer Center	25	2024-11-19 → 2030-02-22
A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI)NCT06389799	Phase 2	Recruiting	Lund University Hospital	33	2024-06-20 → 2028-12-31
A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement NCT06728410	Phase 2	Recruiting	Mehmet Akce	38	2026-01-27 → 2028-07
A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors NCT03914794	Phase 2	Completed	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	30	2020-10-02 → 2025-09-30
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)NCT02924376	Phase 2	Completed	Incyte Corporation	147	2017-01-16 → 2022-02-01
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)NCT02872714	Phase 2	Completed	Incyte Corporation	263	2017-01-12 → 2022-02-01
Phase 1 Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations NCT04258527	Phase 1	Completed	Innovent Biologics (Suzhou) Co. Ltd.	12	2020-03-26 → 2021-03-08
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)NCT03011372	Phase 2	Completed	Incyte Corporation	47	2017-04-25 → 2024-10-30

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$13564.63

Highest Price

$18744.25

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50881-0026-01PEMAZYRE 4.5MG TAB	$13590.56	Big4	Incyte Corporation	08/14/2026
50881-0026-01PEMAZYRE 4.5MG TAB	$18744.25	FSS	Incyte Corporation	08/14/2026
50881-0027-01PEMAZYRE 9MG TAB	$13564.63	Big4	Incyte Corporation	08/14/2026
50881-0027-01PEMAZYRE 9MG TAB	$18744.25	FSS	Incyte Corporation	08/14/2026
50881-0028-01PEMAZYRE 13.5MG TAB	$13566.17	Big4	Incyte Corporation	08/14/2026
50881-0028-01PEMAZYRE 13.5MG TAB	$18744.25	FSS	Incyte Corporation	08/14/2026

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

Medicare Part D Spending

CMS annual spending data for Pemazyre (2024)

Total Spending

$29.5M

Total Claims

1,481

Beneficiaries

221

Avg Cost/Unit

$1327.70

Spending Trend

$6.3M(2020)→$19.1M(2021)→$25.7M(2022)→$26.3M(2023)→$29.5M(2024)

YoY Change:+0.3%

5yr CAGR:+1.3%

Source: CMS Medicare Part D Spending by Drug (2024). 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.

MSN LABORATORIES PRIVATE LTDPEMIGATINIB

DMF 388692023

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Aug 29, 2022	SUPPL -2	View Letter (PDF)
Feb 24, 2021	SUPPL -1	View Letter (PDF)
Apr 20, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 4.5MG

RLD

10 patents2 exclusivities▴

TABLET;ORAL | Approved: Apr 17, 2020

Patents (10)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9611267	Jan 30, 2035	—	Yes	Yes	—	—
10131667	Apr 17, 2034	—	—	—		—
11466004	May 3, 2039	—	—	—		—
11466004	May 3, 2039	—	—	—		—
11466004	May 3, 2039	—	—	—		—
11628162	Aug 30, 2040	—	—	—		—
11628162	Aug 30, 2040	—	—	—		—
11628162	Aug 30, 2040	—	—	—		—
11628162	Aug 30, 2040	—	—	—		—
12552792	Oct 3, 2040	—	Yes	Yes	—	—

Exclusivities (2)

Code	Date	Status
ODE-292	Apr 17, 2027	< 1 year
ODE-404	Aug 26, 2029	Active

#002 — 9MG

RLD

10 patents2 exclusivities▾

TABLET;ORAL | Approved: Apr 17, 2020

#003 — 13.5MG

RLD

10 patents2 exclusivities▾

TABLET;ORAL | Approved: Apr 17, 2020