MIDOSTAURIN - Generic Drug Details

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

Midostaurin is the generic ingredient in two branded drugs marketed by Dr Reddys, Lupin, Teva Pharms, and Novartis, and is included in four NDAs. 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:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	49
Patent Applications:	7,631
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
Acute Leukemia French Association	Phase 2
French Innovative Leukemia Organisation	Phase 2
Shaare Zedek Medical Center	Phase 2

See all MIDOSTAURIN clinical trials

Generic filers with tentative approvals for MIDOSTAURIN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	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	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin	MIDOSTAURIN	midostaurin	CAPSULE;ORAL	216015-001	May 10, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
>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
Hungary	0401642		⤷ Sign Up
China	100457111		⤷ Sign Up
World Intellectual Property Organization (WIPO)	03037347		⤷ Sign Up
Brazil	PI0411563	uso para derivados de estaurosporina	⤷ Sign Up
>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
1441737	18C1012	France	⤷ Sign Up	PRODUCT NAME: MIDOSTAURINE; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574	1890003-5	Sweden	⤷ Sign Up	PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REG. NO/DATE: EU/1/17/1218 20170920
1638574	2017C/067	Belgium	⤷ Sign Up	PRODUCT NAME: MIDOSTAURIN OU UN DE SES SELS (RYDAPT); AUTHORISATION NUMBER AND DATE: EU/1/17/1218 20170920
1638574	293 1-2018	Slovakia	⤷ Sign Up	PRODUCT NAME: MIDOSTAURIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1218 20170920
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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