Generic entry timeline

Mifeprex generics — when can they launch?

Mifeprex (MIFEPRISTONE) · Corcept Therap · 18 active US patents · 0 expired

Earliest patent expiry

2028-08-27

2 years remaining

Full patent estate to

2038-08-22

complete protection through 2038

FDA approval

2000

Corcept Therap

Where Mifeprex sits in the generic timeline

Imminent generic cliff: earliest active US patent for Mifeprex 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.

Method of Use — 18 patents

FDA U-codes carved out by Mifeprex 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-1643`	(no description)

Sample patent estate

Showing 6 of 18 active US patents. View full estate on the Mifeprex drug page →

US8921348 Method of Use · expires 2028-08-27

This patent protects a method for optimizing mifepristone levels in patients by adjusting daily doses based on serum level tests.

USPTO title: Optimizing mifepristone levels in plasma serum of patients suffering from mental disorders treatable with glucocorticoid receptor antagonists
US10842801 Method of Use · expires 2032-11-15

This patent protects a method of increasing mifepristone absorption into the blood by administering it with meals.

USPTO title: Optimizing mifepristone absorption
US10500216 Method of Use · expires 2033-03-05

This patent protects a method of increasing mifepristone absorption into the blood by administering it with meals.

USPTO title: Optimizing mifepristone absorption
US9943526 Method of Use · expires 2036-04-20

This patent protects a method for optimizing mifepristone levels in patients with Cushing's syndrome by adjusting daily doses based on serum level testing.

USPTO title: Optimizing mifepristone levels for cushing's patients
US10166242 Method of Use · expires 2036-04-20

This patent protects a method for optimizing mifepristone levels in patients with Cushing's syndrome by adjusting daily doses based on serum level testing.

USPTO title: Optimizing mifepristone levels for Cushing's patients
US10166243 Method of Use · expires 2036-04-20

This patent protects a method for optimizing mifepristone levels in patients with Cushing's syndrome by adjusting daily doses based on serum level testing.

USPTO title: Optimizing mifepristone levels for cushing'S patients

Sources

FDA Orange Book — patents listed against Mifeprex (NDA filed 2000)
Mifeprex drug profile — full patent estate, indications, clinical trials, pricing
Corcept Therap patent portfolio
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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