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RYDAPT

NDA

MIDOSTAURIN | N207997 | NOVARTIS PHARMACEUTICALS CORP

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

Today

7973031

Oct. 9, 2028

8575146

Dec. 2, 2030

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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Novartis Pharmaceuticals Corporation et al v. Lotus Pharmaceutical Co., Ltd. et al 1:2021cv01107	D. Del.	2021-07-30	Terminated 2023-12-12	—
Novartis Pharmaceuticals Corporation et al v. Dr. Reddys Laboratories, Inc. et al 1:2021cv01106	D. Del.	2021-07-29	Terminated 2023-12-11	—
Novartis Pharmaceuticals Corporation v. Lupin Inc. 1:2021cv01105	D. Del.	2021-07-29	Terminated 2023-12-05	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

41 trials from ClinicalTrials.gov — 1 recruiting, 5 active, 22 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients NCT04097470	Phase 2	Active	Stichting Hemato-Oncologie voor Volwassenen Nederland	140	2019-12-05 → 2026-11
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy NCT04027309	Phase 3	Active	Stichting Hemato-Oncologie voor Volwassenen Nederland	777	2019-12-20 → 2033-06
Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia NCT03836209	Phase 2	Active	PrECOG, LLC.	181	2019-12-06 → 2026-07
RAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDS NCT00819546	Phase 1	Active	Richard Stone, MD	29	2009-01 → 2026-12
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML NCT03591510	Phase 2	Active	Novartis Pharmaceuticals	22	2019-03-13 → 2029-05-18
Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia NCT02115295	Phase 2	Recruiting	M.D. Anderson Cancer Center	508	2014-05-19 → 2030-05-31
Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia NCT03900949	Phase 1	Completed	Uma Borate	21	2019-03-13 → 2025-10-23
A Safety and Efficacy Study of LGH447 in Patients With Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)NCT02078609	Phase 1	Completed	Novartis Pharmaceuticals	70	2014-03-20 → 2019-04-18
Combination of Decitabine and Midostaurin in Patients Older Than 60 With Newly Diagnosed or Relapsed Refractory Acute Myeloid Leukemia NCT01130662	Phase 1	Completed	University of Kansas	16	2010-03 → 2011-10
Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia NCT01174888	Phase 1	Completed	Alison Walker	34	2010-08 → 2016-05

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

VA Federal Supply Schedule

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

Lowest Price

$8084.38

Highest Price

$21472.51

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0698-19RYDAPT 25MG CAPSULE	$21472.51	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0698-19RYDAPT 25MG CAPSULE	$16182.30	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0698-99RYDAPT 25MG CAPSULE	$10736.25	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0698-99RYDAPT 25MG CAPSULE	$8084.38	Big4	Novartis Pharmaceuticals Corporation	08/31/2026

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

Medicare Part D Spending

CMS annual spending data for Rydapt (2024)

Total Spending

$27.4M

Total Claims

1,389

Beneficiaries

330

Avg Cost/Unit

$191.35

Spending Trend

$31.1M(2019)→$37.1M(2020)→$35.3M(2021)→$30.1M(2022)→$30.7M(2023)→$27.4M(2024)

YoY Change:-5.5%

5yr CAGR:+3.9%

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

API Supply Chain9 active DMFs1 inactive

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

MSN LABORATORIES PRIVATE LTDMIDOSTAURIN

DMF 345222020

DR REDDYS LABORATORIES LTDMIDOSTAURIN

DMF 346652020

CONCORD BIOTECH LTDMIDOSTAURIN

DMF 349762020

DR REDDYS LABORATORIES LTDMIDOSTAURIN AMORPHOUS

DMF 352312020

PROCOS SPAMIDOSTAURIN

DMF 352812020

TAPI NL BVMIDOSTAURIN

DMF 352892020

HUBEI HONCH PHARMACEUTICAL CO LTDMIDOSTAURIN

DMF 355622021

HETERO LABS LTDMIDOSTAURIN

DMF 366062021

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDMIDOSTAURIN

DMF 366402021

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDInactiveMIDOSTAURIN

DMF 349902022

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
May 23, 2023	SUPPL -10	View Letter (PDF)
Nov 18, 2021	SUPPL -8	View Letter (PDF)
Apr 22, 2021	SUPPL -7	View Letter (PDF)
Nov 27, 2020	SUPPL -6	View Letter (PDF)
Mar 5, 2020	SUPPL -4	View Letter (PDF)
Jun 27, 2018	SUPPL -2	View Letter (PDF)
Jun 28, 2017	ORIG -2	View Letter (PDF)
Apr 28, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG

RLDAB

2 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 28, 2017

Patents (2) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7973031	Oct 9, 2028	—	—	—		—
8575146	Dec 2, 2030	—	—	—		—