FDA Orange Book · active-ingredient family
Loxapine
Loxapine: 1 brand, 0 generics; first approved Dec 21, 2012; on patent until Oct 23, 2026.
On patent
Generic status & protection
Protected until Oct 23, 2026 (earliest listed patent expiry).
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
1
Next patent expiry
Oct 23, 2026
today
Brand (NDA) products
Originator applications
- NOVA PNEUMANDA 0225492012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG POWDER INHALATION Rx -
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8387612 | today | Product |
Approval history
FDA approval span
First approval
14 yr ago
Most recent approval
14 yr ago
All 1 application were approved in 2012.
Brand (NDA) 1100%
Generic (ANDA) 00%
Loxapine: 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.
Assyro Intelligence
Ask anything about Loxapine
Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.
Evaluating for a team? Book a demo