FDA Orange Book · active-ingredient family
Azelastine hydrochloride; fluticasone propionate
Azelastine hydrochloride; fluticasone propionate: 1 brand, 3 generics; first approved May 01, 2012; generic available.
Generic available
Generic status & protection
Generic available: 3 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
2
Next patent expiry
Feb 24, 2026
6 mo ago
Brand (NDA) products
Originator applications
- DYMISTARLDMYLAN SPECIALITY LPNDA 2022362012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED NASAL Rx AB
Generic (ANDA) products (3)
Abbreviated applications
- TEVA PHARMS USA INCANDA 2084362025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED NASAL Rx AB - PADAGIS ISRAELANDA 2081112021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED NASAL Rx AB - APOTEXANDA 2077122017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED NASAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8168620 | 6 mo ago | Product | |
| 8168620*PED | in 1 d |
Approval history
FDA approval span
First approval
14 yr 6 mo ago
Most recent approval
1 yr 5 mo ago
Approvals span 2012–2025 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Azelastine hydrochloride; fluticasone propionate: 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.
