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Kuvan® — Competitive Intelligence Brief

Kuvan® (Kuvan®) competitive landscape: 1 comparator, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Cofactor replacement therapy. Area: Metabolic/Genetic Disorders.

marketed Cofactor replacement therapy Phenylalanine ammonia-lyase (PAL) enzyme cofactor Metabolic/Genetic Disorders Small molecule Live · refreshed every 30 min

Target snapshot

Kuvan® (Kuvan®) — Merck KGaA, Darmstadt, Germany. Kuvan is a synthetic form of tetrahydrofolate (BH4) that acts as a cofactor to restore phenylalanine ammonia-lyase (PAL) enzyme activity, enabling the metabolism of phenylalanine in patients with phenylketonuria.

Comparator set (1 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Kuvan® TARGET Kuvan® Merck KGaA, Darmstadt, Germany marketed Cofactor replacement therapy Phenylalanine ammonia-lyase (PAL) enzyme cofactor
saproterin dihydrochloride saproterin dihydrochloride University Hospitals Cleveland Medical Center marketed Cofactor replacement therapy Phenylalanine ammonia-lyase (PAL) cofactor

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Cofactor replacement therapy class)

  1. Merck KGaA, Darmstadt, Germany · 1 drug in this class
  2. University Hospitals Cleveland Medical Center · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Kuvan® — Competitive Intelligence Brief. https://druglandscape.com/ci/kuvan. Accessed 2026-05-18.

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