MIDOSTAURIN Drug Patent Profile
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Which patents cover Midostaurin, and when can generic versions of Midostaurin launch?
Midostaurin is a drug marketed by Teva Pharms and is included in one NDA.
The generic ingredient in MIDOSTAURIN 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 Midostaurin
A generic version of MIDOSTAURIN was approved as midostaurin by TEVA PHARMS on April 29th, 2024.
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Summary for MIDOSTAURIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 50 |
| Clinical Trials: | 49 |
| Patent Applications: | 3,838 |
| 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 |
|---|---|
| French Innovative Leukemia Organisation | Phase 2 |
| Acute Leukemia French Association | Phase 2 |
| Shaare Zedek Medical Center | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for MIDOSTAURIN
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms | MIDOSTAURIN | midostaurin | CAPSULE;ORAL | 216076-001 | Apr 29, 2024 | AB | RX | No | No | ⤷ 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 |
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 |
