FDA Orange Book · active-ingredient family
Azelastine hydrochloride
Azelastine hydrochloride: 4 brands, 27 generics; first approved Nov 01, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 27 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
4
Generics (ANDA)
27
Listed patents
1
Next patent expiry
Jun 04, 2028
in 1 yr 8 mo
Brand (NDA) products
Originator applications
- BAYER HLTHCARENDA 21387220212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2055MG/SPRAY SPRAY, METERED NASAL OTC — 0.2055MG/SPRAY SPRAY, METERED NASAL OTC — - ASTEPRORLDVIATRISNDA 02220320082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY SPRAY, METERED NASAL Discontinued — 0.2055MG/SPRAY SPRAY, METERED NASAL Discontinued — - OPTIVARRLDRISINGNDA 0211272000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Discontinued — - ASTELINRLDRISINGNDA 0201141996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY SPRAY, METERED NASAL Discontinued —
Generic (ANDA) products (27)
Abbreviated applications
- AUROBINDO PHARMAANDA 2165612025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2055MG/SPRAY SPRAY, METERED NASAL OTC — - AZELASTINE HYDROCHLORIDEAMNEALANDA 2165762024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2055MG/SPRAY SPRAY, METERED NASAL Discontinued — - APOTEXANDA 21642120242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2055MG/SPRAY SPRAY, METERED NASAL OTC — 0.2055MG/SPRAY SPRAY, METERED NASAL OTC — - AZELASTINE HYDROCHLORIDEPADAGIS ISRAELANDA 2168012024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2055MG/SPRAY SPRAY, METERED NASAL Discontinued — - AZELASTINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 2127752020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2055MG/SPRAY SPRAY, METERED NASAL Discontinued — - AZELASTINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 2122892020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY SPRAY, METERED NASAL Rx AB - AZELASTINE HYDROCHLORIDEGLANDANDA 2100922020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Rx AT - AZELASTINE HYDROCHLORIDESCIEGEN PHARMSANDA 2100322019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2055MG/SPRAY SPRAY, METERED NASAL Discontinued — - AZELASTINE HYDROCHLORIDEEPIC PHARMA LLCANDA 2076102019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY SPRAY, METERED NASAL Rx AB - AZELASTINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 2074112019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Rx AT - AZELASTINE HYDROCHLORIDEALEMBICANDA 2096202019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Rx AT - AZELASTINE HYDROCHLORIDEAMNEALANDA 2081992017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2055MG/SPRAY SPRAY, METERED NASAL Discontinued — - AZELASTINE HYDROCHLORIDEHIKMAANDA 2072432017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2055MG/SPRAY SPRAY, METERED NASAL Discontinued — - AZELASTINE HYDROCHLORIDEAMNEALANDA 2046602017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY SPRAY, METERED NASAL Rx AB - AZELASTINE HYDROCHLORIDEALKEM LABS LTDANDA 2081562017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY SPRAY, METERED NASAL Rx AB - AZELASTINE HYDROCHLORIDEZYDUS PHARMSANDA 0914092017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY SPRAY, METERED NASAL Rx AB - AZELASTINE HYDROCHLORIDEPADAGIS USANDA 2026092017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY SPRAY, METERED NASAL Discontinued — - AZELASTINE HYDROCHLORIDEEPIC PHARMA LLCANDA 2036602016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Discontinued — - AZELASTINE HYDROCHLORIDEBIONPHARMAANDA 0901762015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY SPRAY, METERED NASAL Discontinued — - AZELASTINE HYDROCHLORIDEHIKMAANDA 0914442014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY SPRAY, METERED NASAL Discontinued — - AZELASTINE HYDROCHLORIDEPADAGIS ISRAELANDA 2027432014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2055MG/SPRAY SPRAY, METERED NASAL Discontinued — - AZELASTINE HYDROCHLORIDEAPOTEX INCANDA 2018462012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2055MG/SPRAY SPRAY, METERED NASAL Discontinued — - AZELASTINE HYDROCHLORIDERSSANDOZANDA 2023052012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Rx AT - AZELASTINE HYDROCHLORIDESUN PHARMANDA 0904232012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY SPRAY, METERED NASAL Discontinued — - AZELASTINE HYDROCHLORIDESUN PHARMANDA 0787382010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Discontinued — - AZELASTINE HYDROCHLORIDEAPOTEXANDA 0786212009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Rx AT - AZELASTINE HYDROCHLORIDERSAPOTEX INCANDA 0779542009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.137MG/SPRAY SPRAY, METERED NASAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8071073 | in 1 yr 8 mo | Product |
Approval history
FDA approval span
First approval
30 yr 5 mo ago
Most recent approval
1 yr 9 mo ago
Approvals span 1996–2025 across 31 FDA applications.
Brand (NDA) 413%
Generic (ANDA) 2787%
Azelastine 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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- 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.
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