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 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for midostaurin
Generic Entry Date for midostaurin*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL) Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for midostaurin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Shaare Zedek Medical Center | Phase 2 |
Baptist Health South Florida | Phase 1/Phase 2 |
Jazz Pharmaceuticals | Phase 1/Phase 2 |
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 |
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
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
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
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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1638574 | NOUVELLE UTILISATION DE DERIVES DE STAUROSPORINE (NEW PHARMACEUTICAL USES OF STAUROSPORINE DERIVATIVES) | ⤷ Try a Trial |
Cyprus | 1110179 | ⤷ Try a Trial | |
Poland | 1638574 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for midostaurin
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 | 6/2018 | Austria | ⤷ Try a Trial | PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1218 20170920 |
1638574 | SPC/GB18/001 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REGISTERED: UK EU/1/17/1218(FOR NI) 20170920; UK PLGB 00101/1130 20170920 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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