AZELASTINE HYDROCHLORIDE generics — when can they launch?
AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE) · · 5 active US patents · 1 expired
Where AZELASTINE HYDROCHLORIDE sits in the generic timeline
All listed Orange Book patents for AZELASTINE HYDROCHLORIDE have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Formulation — 4 patents
- Other — 1 patent
Sample patent estate
Showing 5 of 5 active US patents. View full estate on the AZELASTINE HYDROCHLORIDE drug page →
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This patent protects a pharmaceutical product that combines azelastine or a derivative with a steroid, suitable for nasal or ocular administration.USPTO title: Combination of azelastine and steroids
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This patent protects pharmaceutical compositions containing azelastine hydrochloride, including optional additional active agents and carriers to reduce post-nasal drip and bitter taste.USPTO title: Compositions comprising azelastine and methods of use thereof
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This patent protects pharmaceutical compositions containing azelastine hydrochloride, including optional additional active agents and carriers to reduce post-nasal drip and bitter taste.USPTO title: Compositions comprising azelastine and methods of use thereof
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This patent protects pharmaceutical compositions containing azelastine hydrochloride, including optional additional active agents and carriers to reduce post-nasal drip and bitter taste.USPTO title: Compositions comprising azelastine and methods of use thereof
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This patent protects pharmaceutical compositions containing azelastine hydrochloride, including optional additional active agents and carriers to reduce post-nasal drip and bitter taste.USPTO title: Compositions comprising azelastine and methods of use thereof
Sources
- FDA Orange Book — patents listed against AZELASTINE HYDROCHLORIDE (NDA filed 1996)
- AZELASTINE HYDROCHLORIDE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2026 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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