Details for New Drug Application (NDA): 219792
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NDA 219792 describes KYGEVVI, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the KYGEVVI profile page.
The generic ingredient in KYGEVVI is doxecitine; doxribtimine. One supplier is listed for this compound. Additional details are available on the doxecitine; doxribtimine profile page.
The generic ingredient in KYGEVVI is doxecitine; doxribtimine. One supplier is listed for this compound. Additional details are available on the doxecitine; doxribtimine profile page.
Summary for 219792
| Tradename: | KYGEVVI |
| Applicant: | Ucb Inc |
| Ingredient: | doxecitine; doxribtimine |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219792
Generic Entry Date for 219792*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
FOR SOLUTION;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: 219792
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KYGEVVI | doxecitine; doxribtimine | FOR SOLUTION;ORAL | 219792 | NDA | UCB, Inc. | 50474-350 | 50474-350-30 | 30 PACKET in 1 CARTON (50474-350-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (50474-350-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 2GM/PACKET;2GM/PACKET | ||||
| Approval Date: | Nov 3, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 3, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 7, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF THYMIDINE KINASE 2 DEFICIENCY (TK2D) IN ADULTS AND PEDIATRIC PATIENTS WITH AN AGE OF SYMPTOM ONSET ON OR BEFORE 12 YEARS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 19, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF THYMIDINE KINASE 2 DEFICIENCY (TK2D) IN ADULTS AND PEDIATRIC PATIENTS WITH AN AGE OF SYMPTOM ONSET ON OR BEFORE 12 YEARS | ||||||||
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