Assyro AI

Orange Book product · Brand (NDA)

PROCYSBI

CYSTEAMINE BITARTRATE

Brand (NDA)NDA 203389RX HORIZON
View CYSTEAMINE BITARTRATE familyOpen on FDA Orange Book

At a glance

Apr 30, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

24

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 30, 2013

    13 yr 4 mo ago

  2. Today

  3. Patent 9192590 expires

    Listed method-of-use patent (U-1399) expiration.

    Jan 26, 2027

    in 7 mo

  4. Patent 9198882 expires

    Listed method-of-use patent (U-1399) expiration.

    Jan 26, 2027

    in 7 mo

  5. Patent 9925156 expires

    Listed drug substance patent expiration.

    Jan 26, 2027

    in 7 mo

  6. Patent 9925157 expires

    Listed drug substance patent expiration.

    Jan 26, 2027

    in 7 mo

  7. Patent 9925158 expires

    Listed drug substance patent expiration.

    Jan 26, 2027

    in 7 mo

  8. Patent 9192590*PED expires

    Listed listed patent expiration.

    Jul 26, 2027

    in 1 yr 1 mo

  9. Patent 9198882*PED expires

    Listed listed patent expiration.

    Jul 26, 2027

    in 1 yr 1 mo

  10. Patent 9925156*PED expires

    Listed listed patent expiration.

    Jul 26, 2027

    in 1 yr 1 mo

  11. Patent 9925157*PED expires

    Listed listed patent expiration.

    Jul 26, 2027

    in 1 yr 1 mo

  12. Patent 9925158*PED expires

    Listed listed patent expiration.

    Jul 26, 2027

    in 1 yr 1 mo

  13. Patent 8026284 expires

    Listed method-of-use patent (U-1399) expiration.

    Sep 22, 2027

    in 1 yr 3 mo

  14. Patent 8026284*PED expires

    Listed listed patent expiration.

    Mar 22, 2028

    in 1 yr 9 mo

  15. Patent 9173851 expires

    Listed drug product patent expiration.

    Jun 17, 2034

    in 8 yr 1 mo

  16. Patent 9233077 expires

    Listed drug product patent expiration.

    Jun 17, 2034

    in 8 yr 1 mo

  17. Patent 9173851*PED expires

    Listed listed patent expiration.

    Dec 17, 2034

    in 8 yr 7 mo

  18. Patent 9233077*PED expires

    Listed listed patent expiration.

    Dec 17, 2034

    in 8 yr 7 mo

  19. Patent 10143665 expires

    Listed method-of-use patent (U-1399) expiration.

    Aug 16, 2036

    in 10 yr 4 mo

  20. Patent 10328037 expires

    Listed method-of-use patent (U-1399) expiration.

    Aug 16, 2036

    in 10 yr 4 mo

  21. Patent 10548859 expires

    Listed method-of-use patent (U-1399) expiration.

    Aug 16, 2036

    in 10 yr 4 mo

  22. Patent 10905662 expires

    Listed method-of-use patent (U-1399) expiration.

    Aug 16, 2036

    in 10 yr 4 mo

  23. Patent 10143665*PED expires

    Listed listed patent expiration.

    Feb 16, 2037

    in 10 yr 10 mo

  24. Patent 10328037*PED expires

    Listed listed patent expiration.

    Feb 16, 2037

    in 10 yr 10 mo

  25. Patent 10548859*PED expires

    Listed listed patent expiration.

    Feb 16, 2037

    in 10 yr 10 mo

  26. Patent 10905662*PED expires

    Listed listed patent expiration.

    Feb 16, 2037

    in 10 yr 10 mo

Pharmaceutical detail

Active ingredient

CYSTEAMINE BITARTRATE

Strength

EQ 75MG BASE

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 203389

Product number

002

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (24)

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

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

Book a Demo