RYDAPT Drug Patent Profile
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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 29th, 2024.
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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 |
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 |
Technische Universität Dresden | Phase 1/Phase 2 |
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
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
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
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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1110179 | ⤷ Sign Up | |
Canada | 2527703 | NOUVELLE UTILISATION DE DERIVES DE STAUROSPORINE (NEW PHARMACEUTICAL USES OF STAUROSPORINE DERIVATIVES) | ⤷ Sign Up |
Slovenia | 1441737 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2004112794 | ⤷ Sign Up | |
Poland | 1638574 | ⤷ Sign Up | |
Brazil | 0213739 | ⤷ Sign Up | |
Japan | 5057780 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RYDAPT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1638574 | C01638574/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: MIDOSTAURIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66310 04.05.2017 |
1638574 | 122018000016 | Germany | ⤷ Sign Up | PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1218 20170918 |
1638574 | 17C1063 | France | ⤷ Sign Up | PRODUCT NAME: MIDOSTAURINE OU L'UN DE SES SELS; 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 | CR 2018 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920 |
1638574 | 6/2018 | Austria | ⤷ Sign Up | PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1218 20170920 |
1638574 | C 2017 049 | Romania | ⤷ Sign Up | PRODUCT NAME: MIDOSTAURINA SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1218; DATE OF NATIONAL AUTHORISATION: 20170918; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1218; DATE OF FIRST AUTHORISATION IN EEA: 20170918 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |