Details for New Drug Application (NDA): 219876
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NDA 219876 describes MODEYSO, which is a drug marketed by Chimerix and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the MODEYSO profile page.
The generic ingredient in MODEYSO is dordaviprone hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the dordaviprone hydrochloride profile page.
The generic ingredient in MODEYSO is dordaviprone hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the dordaviprone hydrochloride profile page.
Summary for 219876
| Tradename: | MODEYSO |
| Applicant: | Chimerix |
| Ingredient: | dordaviprone hydrochloride |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219876
Generic Entry Date for 219876*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 219876
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MODEYSO | dordaviprone hydrochloride | CAPSULE;ORAL | 219876 | NDA | Jazz Pharmaceuticals, Inc. | 68727-250 | 68727-250-01 | 1 BOTTLE in 1 CARTON (68727-250-01) / 10 CAPSULE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 125MG BASE | ||||
| Approval Date: | Aug 6, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 6, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Aug 6, 2032 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH DIFFUSE MIDLINE GLIOMA HARBORING AN H3 K27M MUTATION WITH PROGRESSIVE DISEASE FOLLOWING PRIOR THERAPY | ||||||||
| Patent: | 10,172,862 | Patent Expiration: | Jan 30, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH DIFFUSE MIDLINE GLIOMA HARBORING AN H3 K27M MUTATION WITH PROGRESSIVE DISEASE FOLLOWING PRIOR THERAPY | ||||||||
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