FDA Orange Book · active-ingredient family
Pitolisant hydrochloride
Pitolisant hydrochloride: 1 brand, 3 generics; first approved Aug 14, 2019; generic available.
Generic available10 exclusivity periods
Generic status & protection
Generic available: 3 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
3
Next patent expiry
Feb 06, 2026
8 mo ago
Brand (NDA) products
Originator applications
- WAKIXRLDHARMONYNDA 21115020192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4.45MG BASE TABLET ORAL Rx AB EQ 17.8MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (3)
Abbreviated applications
- PITOLISANT HYDROCHLORIDELUPINANDA 21884620262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4.45MG BASE TABLET ORAL Rx AB EQ 17.8MG BASE TABLET ORAL Rx AB - PITOLISANT HYDROCHLORIDEMSNANDA 21887320262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4.45MG BASE TABLET ORAL Rx AB EQ 17.8MG BASE TABLET ORAL Rx AB - PITOLISANT HYDROCHLORIDENOVITIUM PHARMAANDA 21849520262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4.45MG BASE TABLET ORAL Rx AB EQ 17.8MG BASE TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NPPNew patient population exclusivity (3 years)
in 9 mo
- ODE-255Orphan-drug exclusivity (7 years)
1 mo ago
- ODE-331Orphan-drug exclusivity (7 years)
in 1 yr 1 mo
- ODE-489Orphan-drug exclusivity (7 years)
in 4 yr 10 mo
- ODE-519Orphan-drug exclusivity (7 years)
in 6 yr 6 mo
- NPPNew patient population exclusivity (3 years)
in 9 mo
- ODE-255Orphan-drug exclusivity (7 years)
1 mo ago
- ODE-331Orphan-drug exclusivity (7 years)
in 1 yr 1 mo
- ODE-489Orphan-drug exclusivity (7 years)
in 4 yr 10 mo
- ODE-519Orphan-drug exclusivity (7 years)
in 6 yr 6 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8354430 | 8 mo ago | U-1101 | |
| 8486947 | in 3 yr 1 mo | U-1101 | |
| 8207197 | in 3 yr 6 mo | SubstanceProduct |
Approval history
FDA approval span
First approval
7 yr 3 mo ago
Most recent approval
1 mo ago
Approvals span 2019–2026 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Pitolisant hydrochloride: 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.
