LOMITAPIDE MESYLATE generics — when can they launch?
LOMITAPIDE MESYLATE (LOMITAPIDE MESYLATE) · · 12 active US patents · 0 expired
Where LOMITAPIDE MESYLATE sits in the generic timeline
Imminent generic cliff: earliest active US patent for LOMITAPIDE MESYLATE expires in 2027 (~1 year 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.
- Method of Use — 12 patents
FDA U-codes carved out by LOMITAPIDE MESYLATE patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-1316 | (no description) |
U-4438 | (no description) |
Sample patent estate
Showing 6 of 12 active US patents. View full estate on the LOMITAPIDE MESYLATE drug page →
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This patent protects methods for treating hyperlipidemia and hypercholesterolemia by administering escalating doses of an MTP inhibitor.USPTO title: Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
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This patent protects methods for treating hyperlipidemia and hypercholesterolemia by administering escalating doses of an MTP inhibitor.USPTO title: Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
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This patent protects methods for treating hyperlipidemia and hypercholesterolemia by administering escalating doses of an MTP inhibitor.USPTO title: Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
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This patent protects methods for treating hyperlipidemia and hypercholesterolemia by administering escalating doses of an MTP inhibitor.USPTO title: Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
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This patent protects methods for treating hyperlipidemia and hypercholesterolemia by administering escalating doses of an MTP inhibitor.USPTO title: Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
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This patent protects methods for treating hyperlipidemia and hypercholesterolemia by administering escalating doses of an MTP inhibitor.USPTO title: Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Sources
- FDA Orange Book — patents listed against LOMITAPIDE MESYLATE (NDA filed 2012)
- LOMITAPIDE MESYLATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2027 — 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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