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FDA Orange Book · active-ingredient family

Cysteamine bitartrate

Cysteamine bitartrate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:PROCYSBI · NDA 213491

3

Brand (NDA)

0

Generics (ANDA)

24

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, capsule, delayed release, granule, delayed release

ProductApplicantApplicationTEApproved
PROCYSBIRLD×2HORIZONNDA 213491—Feb 14, 2020
PROCYSBIRLD×2HORIZONNDA 203389—Apr 30, 2013
CYSTAGONRLD×2MYLANNDA 020392—Aug 15, 1994

Listed patents (24)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9198882Jan 26, 2027in 7 mo
U-1399
9192590Jan 26, 2027in 7 mo
U-1399
9925158Jan 26, 2027in 7 mo
SubstanceProductU-1399
9925157Jan 26, 2027in 7 mo
SubstanceProductU-1399
9925156Jan 26, 2027in 7 mo
SubstanceProductU-1399
9198882*PEDJul 26, 2027in 1 yr 1 mo
9192590*PEDJul 26, 2027in 1 yr 1 mo
9925156*PEDJul 26, 2027in 1 yr 1 mo
9925157*PEDJul 26, 2027in 1 yr 1 mo
9925158*PEDJul 26, 2027in 1 yr 1 mo
8026284Sep 22, 2027in 1 yr 3 mo
U-1399
8026284*PEDMar 22, 2028in 1 yr 9 mo
9173851Jun 17, 2034in 8 yr 1 mo
Product
9233077Jun 17, 2034in 8 yr 1 mo
Product
9233077*PEDDec 17, 2034in 8 yr 7 mo
9173851*PEDDec 17, 2034in 8 yr 7 mo
10328037Aug 16, 2036in 10 yr 4 mo
U-1399
10548859Aug 16, 2036in 10 yr 4 mo
U-1399
10143665Aug 16, 2036in 10 yr 4 mo
U-1399
10905662Aug 16, 2036in 10 yr 4 mo
U-1399
10143665*PEDFeb 16, 2037in 10 yr 10 mo
10548859*PEDFeb 16, 2037in 10 yr 10 mo
10328037*PEDFeb 16, 2037in 10 yr 10 mo
10905662*PEDFeb 16, 2037in 10 yr 10 mo

Cysteamine bitartrate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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