FDA Orange Book · active-ingredient family
Olodaterol hydrochloride
Olodaterol hydrochloride: 1 brand, 0 generics; first approved Jul 31, 2014; on patent until Jan 19, 2027.
On patent
Generic status & protection
Protected until Jan 19, 2027 (earliest listed patent expiry).
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
1
Next patent expiry
Jan 19, 2027
in 5 mo
Brand (NDA) products
Originator applications
- BOEHRINGER INGELHEIMNDA 2031082014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.0025MG BASE/INH SPRAY, METERED INHALATION Rx —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7727984 | in 5 mo | Substance |
Approval history
FDA approval span
First approval
12 yr 3 mo ago
Most recent approval
12 yr 3 mo ago
All 1 application were approved in 2014.
Brand (NDA) 1100%
Generic (ANDA) 00%
Olodaterol 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.
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