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DAURISMO

NDA

GLASDEGIB MALEATE | N210656 | PFIZER INC

2 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Nov. 21, 2032

Jun. 29, 2028

Apr. 13, 2036

Apr. 13, 2036

Apr. 13, 2036

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Avadel Specialty Pharmaceuticals, LLC FDA-2018-P-1949 · 45 docket documents Avadel Specialty Pharmaceuticals, LLC filed this citizen petition pursuant to Section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving Ferring Pharmaceuticals' new drug application NDA 022517 for desmopressin acetate (Nocdurna) for treatment of noctur	505(q)	2018-05-21	Denied	Avadel Specialty Pharmaceuticals, LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

10 trials from ClinicalTrials.gov, 1 active, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia NCT04231851	Phase 2	Active	University of California, Irvine	30	2020-02-19 → 2027-06-30
Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia NCT03226418	Phase 2	Completed	University of Nebraska	75	2017-07-07 → 2024-10-01
A Study Of Glasdegib In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The ICH Formulation NCT03130556	Phase 1	Completed	Pfizer	24	2017-05-01 → 2017-07-21
Glasdegib (PF-04449913) With Temozolomide Newly Diagnosed Glioblastoma NCT03466450	Phase 1/2	Completed	Grupo Español de Investigación en Neurooncología	75	2018-03-15 → 2023-11-29
Molecular Profiling of Advanced Soft-tissue Sarcomas NCT03784014	Phase 3	Completed	Institut National de la Santé Et de la Recherche Médicale, France	603	2019-10-19 → 2026-01-20
A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia NCT03416179	Phase 3	Completed	Pfizer	730	2018-04-20 → 2022-01-17
A Phase 1 Study To Evaluate The Effect Of Glasdegib On The Cardiac Repolarization In Healthy Subjects NCT03162900	Phase 1	Completed	Pfizer	36	2017-06-09 → 2017-10-16
OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Relapsed or Refractory Acute Myeloid Leukemia NCT03390296	Phase 1/2	Completed	M.D. Anderson Cancer Center	50	2017-12-27 → 2022-02-04
GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia NCT04051996	Phase 2	Terminated	Yale University	1	2019-12-06 → 2020-06-09
Single-Agent Glasdegib In Patients With Myelofibrosis Previously Treated With Ruxolitinib NCT02226172	Phase 2	Terminated	Pfizer	21	2014-10-06 → 2018-01-31

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$16525.18

Highest Price

$22338.54

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00069-0298-60DAURISMO 25MG TAB	$22338.54	FSS	Pfizer Inc.	06/30/2029
00069-0298-60DAURISMO 25MG TAB	$16525.18	Big4	Pfizer Inc.	06/30/2029
00069-1531-30DAURISMO 100MG TAB	$22338.54	FSS	Pfizer Inc.	06/30/2029
00069-1531-30DAURISMO 100MG TAB	$16543.88	Big4	Pfizer Inc.	06/30/2029

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

Medicare Part D Spending

CMS annual spending data for Daurismo (2024)

Total Spending

$3.7M

Total Claims

174

Beneficiaries

Avg Cost/Unit

$653.50

Spending Trend

$4.5M(2019)→$6.6M(2020)→$4.7M(2021)→$4.6M(2022)→$2.9M(2023)→$3.7M(2024)

YoY Change:-5.4%

5yr CAGR:+2.5%

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Mar 28, 2023	SUPPL -5	View Letter (PDF)
Mar 20, 2020	SUPPL -4	View Letter (PDF)
Mar 20, 2020	SUPPL -2	View Letter (PDF)
Dec 10, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 25MG BASE

RLD

5 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 21, 2018

Patents (5) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8148401	Nov 21, 2032	—	Yes	Yes	—	—
8431597	Jun 29, 2028	—	—	Yes	—	—
10414748	Apr 13, 2036	—	Yes	Yes	—	—
11168066	Apr 13, 2036	—	—	—		—
11891372	Apr 13, 2036	—	—	—		—

#002 — EQ 100MG BASE

RLD

5 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 21, 2018