Tecfidera generics — when can they launch?
Tecfidera (DIMETHYL FUMARATE) · Biogen · 18 active US patents · 0 expired
Where Tecfidera sits in the generic timeline
Imminent generic cliff: earliest active US patent for Tecfidera 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 Tecfidera 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-1384 | (no description) |
U-3148 | (no description) |
Sample patent estate
Showing 6 of 18 active US patents. View full estate on the Tecfidera drug page →
-
This patent protects methods of using certain compounds to treat neurological diseases, such as multiple sclerosis, by slowing or reducing demyelination and cell death.USPTO title: Treatment for multiple sclerosis
-
This patent protects methods of using certain compounds to treat neurological diseases, such as multiple sclerosis, by slowing or reducing demyelination and cell death.USPTO title: Treatment for multiple sclerosis
-
This patent protects a method of treating or preventing a disease or disorder, such as multiple sclerosis, by administering a fumarate agent, a vaccine, and a second dose of the fumarate agent.USPTO title: Dimethyl fumarate and vaccination regimens
-
This patent protects a method of treating or preventing a disease or disorder, such as multiple sclerosis, by administering a fumarate agent, a vaccine, and a second dose of the fumarate agent.USPTO title: Dimethyl fumarate and vaccination regimens
-
This patent protects a method of treating or preventing a disease or disorder, such as multiple sclerosis, by administering a fumarate agent, a vaccine, and a second dose of the fumarate agent.USPTO title: Dimethyl fumarate and vaccination regimens
-
This patent protects a method of treating or preventing a disease or disorder, such as multiple sclerosis, by administering a fumarate agent, a vaccine, and a second dose of the fumarate agent.USPTO title: Dimethyl fumarate and vaccination regimens
Sources
- FDA Orange Book — patents listed against Tecfidera (NDA filed 2013)
- Tecfidera drug profile — full patent estate, indications, clinical trials, pricing
- Biogen 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.
Get generic entry alerts
Free Pharma CI alerts on Tecfidera — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →