Pillstats
Rx only · Powder, For Solution · Oral

Sapropterin Dihydrochloride

Brands: Javygtor · Kuvan · Zelvysia · Sapropterin Dihydrochloride

8 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US16 NDCs
8 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
ATCA16AX07
RxCUI (US)753340
US makers8 labelers
Packages20
DEA / ScheduleNone

Medicaid dispensing volumeSDUD · per quarter

Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.

1.1K2.1K3.2K4.2K2025 Q12025 Q22025 Q32025 Q42026 Q1
2.8K
Rx · 2026 Q1
212K
Units dispensed
-21%
Rx vs. year ago
5
Quarters · since 2025 Q1

Who makes it8 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

LabelerTypePackagesStatus
Camber Pharmaceuticals, Inc.unknown4SUPPLYING
TRUPHARMA, LLCunknown4SUPPLYING
Micro Labs Limitedunknown2SUPPLYING
Dr.Reddy's laboratories Limitedunknown2SUPPLYING
BioMarin Pharmaceutical Inc.unknown2SUPPLYING
NorthStar RxLLCunknown2SUPPLYING
Aucta Pharmaceuticals, Inc.unknown2SUPPLYING
Par Health USA, LLCunknown2SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

  • Apr 8, 2024
    RECALLRecall (Class I): Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distr…

    Sub-potent Drug; powder discoloration associated with decreased potency — Recalling firm: Dr. Reddy's Laboratories, Inc. — Nationwide in the USA