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Prescription medicine

Doxecitine and doxribtimine Brand names: Kygevvi

Doxecitine and doxribtimine (Kygevvi) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the doxecitine and doxribtimine FDA label on DailyMed (effective November 10, 2025, UCB, Inc.); the NDA 219792 record on Drugs@FDA; every doxecitine and doxribtimine label on DailyMed.

Highlights of the record

FDA label of November 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

KYGEVVI is indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years.

Forms and strengths

  • 2 g / 2 g

Powder for solution.

On the market

Earliest approval on file
November 3, 2025 Kygevvi, Ucb Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
No generic approved
Labelers listed (NDC)
1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent
August 19, 2040 Kygevvi for solution; not a generic launch date

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
8 through July 30, 2026

What is doxecitine and doxribtimine used for?

From the label: indications and usage

KYGEVVI is indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years. KYGEVVI is a combination of doxecitine and doxribtimine, both pyrimidine nucleosides, indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years.

Source: FDA drug label (KYGEVVI), NDA219792 (Ucb Inc), as published by UCB, Inc., effective November 10, 2025 (SPL set 7d5ce670-9314-4fd7-8b0a-1447910dcf9e), via openFDA; the full label on DailyMed

Is there a generic for doxecitine and doxribtimine (Kygevvi)?

No generic doxecitine and doxribtimine is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 2 patents for Kygevvi for solution, the last expiring on August 19, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 2025 earliest approval on file
  • 2040 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for doxecitine and doxribtimine?

The FDA Adverse Event Reporting System holds 8 reports that list doxecitine and doxribtimine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

  • Off Label Use (a use or a product term, not a reaction)4
  • Dysgeusia1
  • Endotracheal Intubation1
  • Femur Fracture1
  • Gastrostomy1
  • Illness1
  • Incorrect Dose Administered (a use or a product term, not a reaction)1
  • Nasopharyngitis1

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Doxecitine and doxribtimine side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other