FDA Orange Book · active-ingredient family
Pretomanid
Pretomanid: 1 brand, 0 generics; first approved Aug 14, 2019.
Brand only3 exclusivity periods
Generic status & protection
Marketing exclusivity runs through Aug 14, 2029.
Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
1
Brand (NDA) products
Originator applications
- PRETOMANIDRLDRSMYLAN IRELAND LTDNDA 2128622019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NCENew chemical entity exclusivity (5 years)
2 yr ago
- ODE-253Orphan-drug exclusivity (7 years)
in 19 d
- GAINQualified infectious disease product exclusivity (adds 5 years)
in 3 yr 1 mo
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
7 yr 1 mo ago
Most recent approval
7 yr 1 mo ago
All 1 application were approved in 2019.
Brand (NDA) 1100%
Generic (ANDA) 00%
Pretomanid: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
