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FDA Orange Book · active-ingredient family

Tiopronin

Tiopronin is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:THIOLA EC · NDA 211843

2

Brand (NDA)

6

Generics (ANDA)

1

Listed patents

3

Exclusivity periods

Brand (NDA) products · tablet, tablet, delayed release

ProductApplicantApplicationTEApproved
THIOLA ECRLD×2MISSION PHARMACALNDA 211843ABJun 28, 2019
THIOLARLDMISSION PHARMANDA 019569ABAug 11, 1988

Generic (ANDA) products (6)

ProductApplicantApplicationTEApproved
TIOPRONIN×2AMNEALANDA 216278—Aug 29, 2025
TIOPRONIN×2TEVA PHARMS INCANDA 216456ABJul 22, 2024
VENXXIVA×2TORRENTANDA 216990ABJan 30, 2024
TIOPRONIN×2PH HEALTHANDA 217219ABFeb 24, 2023
TIOPRONINPH HEALTHANDA 216198—Jun 02, 2022
TIOPRONINTEVA PHARMS USA INCANDA 214326ABApr 26, 2021

Marketing exclusivity (3)

  • ODE*FDA marketing exclusivity

    Jun 28, 2026

    in 9 d

  • ODE*FDA marketing exclusivity

    Jun 28, 2026

    in 9 d

  • ODE-267Orphan-drug exclusivity (7 years)

    Jun 28, 2026

    in 9 d

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11458104Nov 14, 2038in 12 yr 7 mo
U-3441

Tiopronin — frequently asked questions

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

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