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® Generic Entry Outlook for Rydapt
Rydapt was eligible for patent challenges on April 28, 2021.
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: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 50 |
Clinical Trials: | 12 |
Patent Applications: | 4,743 |
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 |
---|---|
Jazz Pharmaceuticals | Phase 1/Phase 2 |
Baptist Health South Florida | Phase 1/Phase 2 |
Novartis Pharmaceuticals | Phase 1/Phase 2 |
Pharmacology for RYDAPT
Drug Class | Kinase Inhibitor |
Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for RYDAPT
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 RYDAPT
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 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 |
---|---|---|---|
Germany | 60213842 | ⤷ Try a Trial | |
Denmark | 1638574 | ⤷ Try a Trial | |
Israel | 161156 | ⤷ Try a Trial | |
Hungary | S000503 | ⤷ Try a Trial | |
Portugal | 1638574 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RYDAPT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1638574 | 293 1-2018 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: MIDOSTAURIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1218 20170920 |
1638574 | 659 | Finland | ⤷ Try a Trial | |
1441737 | C01441737/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: MIDOSTAURIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66310 04.05.2017 |
1638574 | C 2017 049 | Romania | ⤷ Try a Trial | 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 |
1638574 | 132018000000001 | Italy | ⤷ Try a Trial | 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 |