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RYDAPT Drug Profile
» See Plans and Pricing
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 three patents protecting this drug.
This drug has sixty-one 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.
US ANDA Litigation and Generic Entry Outlook for Rydapt
Rydapt will be eligible for patent challenges on April 28, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 28, 2024. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for RYDAPT
| International Patents: | 61 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 40 |
| Clinical Trials: | 7 |
| Patent Applications: | 3,779 |
| 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 |
Generic Entry Opportunity Date for RYDAPT
Generic Entry Date for RYDAPT*:
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) NDA:
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 RYDAPT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Novartis Pharmaceuticals | Phase 1/Phase 2 |
| Pfizer | 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 |
US Patents and Regulatory Information for RYDAPT
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Novartis | RYDAPT | midostaurin | CAPSULE;ORAL | 207997-001 | Apr 28, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | RYDAPT | midostaurin | CAPSULE;ORAL | 207997-001 | Apr 28, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for RYDAPT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 4959918 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2004112794 | Start Trial |
| Mexico | PA05013722 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RYDAPT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1638574 | 6/2018 | Austria | Start Trial | PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1218 20170920 |
| 1638574 | 17C1063 | France | Start Trial | PRODUCT NAME: MIDOSTAURINE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/17/1218 20170920 |
| 1638574 | 2017/061 | Ireland | Start Trial | PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1218 20170920 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
