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Last Updated: April 29, 2024

Midostaurin - Generic Drug Details

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What are the generic drug sources for midostaurin and what is the scope of freedom to operate?

Midostaurin is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for midostaurin

International Patents:	62
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	48
Patent Applications:	7,232
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for midostaurin
DailyMed Link:	midostaurin at DailyMed

Recent Clinical Trials for midostaurin

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

Sponsor	Phase
Shaare Zedek Medical Center	Phase 2
Jazz Pharmaceuticals	Phase 1/Phase 2
Baptist Health South Florida	Phase 1/Phase 2

See all midostaurin clinical trials

Generic filers with tentative approvals for MIDOSTAURIN

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	25MG	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for midostaurin

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for midostaurin

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

Paragraph IV (Patent) Challenges for MIDOSTAURIN

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

US Patents and Regulatory Information for midostaurin

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Glossary

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

Expired US Patents for midostaurin

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

EU/EMA Drug Approvals for midostaurin

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for midostaurin

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Country	Patent Number	Title	Estimated Expiration
Germany	602004026578		⤷ Try a Trial
Luxembourg	C00055		⤷ Try a Trial
Israel	161156		⤷ Try a Trial
Japan	2012144572	NEW PHARMACEUTICAL USE OF STAUROSPORINE DERIVATIVE	⤷ Try a Trial
Mexico	PA05013722	NUEVOS USOS FARMACEUTICOS DE DERIVADOS DE ESTAUROSPORINA. (NEW PHARMACEUTICAL USES OF STAUROSPORINE DERIVATIVES.)	⤷ Try a Trial
Brazil	0213739		⤷ Try a Trial
Japan	2005507412		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for midostaurin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638574	C201730062	Spain	⤷ Try a Trial	PRODUCT NAME: MIDOSTAURINA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1218; DATE OF AUTHORISATION: 20170918; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1218; DATE OF FIRST AUTHORISATION IN EEA: 20170918
1638574	CA 2018 00001	Denmark	⤷ Try a Trial	PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920
1638574	122018000016	Germany	⤷ Try a Trial	PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1218 20170918
1638574	17C1063	France	⤷ Try a Trial	PRODUCT NAME: MIDOSTAURINE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574	6/2018	Austria	⤷ Try a Trial	PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574	2017C/067	Belgium	⤷ Try a Trial	PRODUCT NAME: MIDOSTAURIN OU UN DE SES SELS (RYDAPT); AUTHORISATION NUMBER AND DATE: EU/1/17/1218 20170920
1638574	C01638574/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: MIDOSTAURIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66310 04.05.2017
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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