BECLOMETHASONE DIPROPIONATE generics — when can they launch?
BECLOMETHASONE DIPROPIONATE (BECLOMETHASONE DIPROPIONATE) · · 44 active US patents · 0 expired
Where BECLOMETHASONE DIPROPIONATE sits in the generic timeline
Imminent generic cliff: earliest active US patent for BECLOMETHASONE DIPROPIONATE expires in 2028 (~2 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
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 — 44 patents
Sample patent estate
Showing 6 of 44 active US patents. View full estate on the BECLOMETHASONE DIPROPIONATE drug page →
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This patent protects a metered-dose inhaler with a dose counter that includes a rotary gear wheel and a display.USPTO title: Metered-dose inhaler
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This patent protects a metered-dose inhaler with a dose counter that includes a rotary gear wheel and a display.USPTO title: Metered-dose inhaler
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This patent protects a dose counter for a metered dose inhaler that counts doses as the canister is used.USPTO title: Dose counter for inhaler and method for counting doses
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This patent protects a dose counter for a metered dose inhaler that counts doses as the canister is used.USPTO title: Dose counter for inhaler and method for counting doses
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This patent protects a dose counter for an inhaler that prevents the medicament canister from being rotated in reverse.USPTO title: Dose counter for inhaler having an anti-reverse rotation actuator
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This patent protects a dose counter for an inhaler that prevents the medicament canister from being rotated in reverse.USPTO title: Dose counter for inhaler having an anti-reverse rotation actuator
Sources
- FDA Orange Book — patents listed against BECLOMETHASONE DIPROPIONATE (NDA filed 1976)
- BECLOMETHASONE DIPROPIONATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2028 — 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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