~ Buy the RYDAPT (midostaurin) Drug Profile, 2024 PDF Report in the Report Store ~

RYDAPT Drug Patent Profile

✉ Email this page to a colleague

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 two 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^® Litigation and Generic Entry Outlook for Rydapt

A generic version of RYDAPT was approved as midostaurin by TEVA PHARMS on April 29^th, 2024.

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for RYDAPT?
What are the global sales for RYDAPT?
What is Average Wholesale Price for RYDAPT?

Summary for RYDAPT

International Patents:	62
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	12
Patent Applications:	3,838
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

Drug patent expirations by year for RYDAPT

Recent Clinical Trials for RYDAPT

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

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

See all RYDAPT clinical trials

Pharmacology for RYDAPT

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

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 two US patents and two FDA Regulatory Exclusivities.

Patents protecting RYDAPT

Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WHO ARE FLT3 MUTATION-POSITIVE, IN COMBINATION WITH STANDARD CYTARABINE AND DAUNORUBICIN INDUCTION AND CYTARABINE CONSOLIDATION CHEMOTHERAPY

Pharmaceutical uses of staurosporine derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL)

FDA Regulatory Exclusivity protecting RYDAPT

TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL)
Exclusivity Expiration: ⤷ Sign Up

TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) THAT IS FLT3 MUTATION-POSITIVE AS DETECTED BY AN FDA APPROVED TEST, IN COMBINATION WITH STANDARD CYTARABINE AND DAUNORUBICIN INDUCTION AND CYTARABINE CONSOLIDATION
Exclusivity Expiration: ⤷ Sign Up

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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
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 RYDAPT

Subscribe to access the full database, or Sign Up
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 RYDAPT

Subscribe to access the full database, or Sign Up
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 RYDAPT

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

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Cyprus	1110179		⤷ Sign Up
China	1582150		⤷ Sign Up
Poland	368322		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for RYDAPT

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638574	6/2018	Austria	⤷ Sign Up	PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574	C20170046 00256	Estonia	⤷ Sign Up	PRODUCT NAME: MIDOSTAURIIN;REG NO/DATE: EU/1/17/1218 20.09.2017
1638574	132018000000001	Italy	⤷ Sign Up	PRODUCT NAME: MIDOSTAURINA O UN SUO SALE(RYDAPT ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1218, 20170920
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description