RYDAPT Drug Patent Profile

When do Rydapt patents expire, and what generic alternatives are available?

Rydapt is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-two patent family members in twenty-seven countries.

The generic ingredient in RYDAPT is midostaurin. One supplier is listed for this compound. Additional details are available on the midostaurin profile page.

DrugPatentWatch^® Generic Entry Outlook for Rydapt

Rydapt was eligible for patent challenges on April 28, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 28, 2024. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (midostaurin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for RYDAPT

International Patents:	62
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	12
Patent Applications:	5,958
Drug Prices:	Drug price information for RYDAPT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RYDAPT
What excipients (inactive ingredients) are in RYDAPT?	RYDAPT excipients list
DailyMed Link:	RYDAPT at DailyMed

See drug prices for RYDAPT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RYDAPT

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL)

NDA:

207997

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for RYDAPT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Baptist Health South Florida	Phase 1/Phase 2
Jazz Pharmaceuticals	Phase 1/Phase 2
Novartis Pharmaceuticals	Phase 1/Phase 2

See all RYDAPT clinical trials

Pharmacology for RYDAPT

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RYDAPT

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for RYDAPT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYDAPT	Capsules	midostaurin	25 mg	207997	4	2021-04-28

US Patents and Regulatory Information for RYDAPT

RYDAPT is protected by three US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting RYDAPT

FDA Regulatory Exclusivity protecting RYDAPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017		RX	Yes	Yes
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017		RX	Yes	Yes
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017		RX	Yes	Yes
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017		RX	Yes	Yes

Expired US Patents for RYDAPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017

EU/EMA Drug Approvals for RYDAPT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Ltd	Rydapt	midostaurin	EMEA/H/C/004095 Rydapt is indicated:in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive (see section 4.2);as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM AHN), or mast cell leukaemia (MCL).	Authorised	no	no	yes	2017-09-18

International Patents for RYDAPT

See the table below for patents covering RYDAPT around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	20042123
Portugal	1441737
Taiwan	I302836
World Intellectual Property Organization (WIPO)	2004112794

Supplementary Protection Certificates for RYDAPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638574	C20170046 00256	Estonia		PRODUCT NAME: MIDOSTAURIIN;REG NO/DATE: EU/1/17/1218 20.09.2017
1638574	293 1-2018	Slovakia		PRODUCT NAME: MIDOSTAURIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574	659	Finland
1638574	132018000000001	Italy		PRODUCT NAME: MIDOSTAURINA O UN SUO SALE(RYDAPT ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1218, 20170920