deflazacort · Ptc Therap · NDA 208684, 208685
Emflaza
Earliest generic entry, as listed · earliest of 5 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic approved · 208685-0013 Oct 2025
- 25 Oct 2026Generic approved · 208684-00112 Dec 2025
- 25 Oct 2026Generic approved · 208684-00119 Oct 2026
- 25 Oct 2026Generic approved · 208685-00127 Jan 2026
- 25 Oct 2026Generic approved · 208685-00128 May 2026
- 25 Oct 2026Generic approved · 208684-00118 Sep 2026
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208684 · 001 · RLD | tablet, oral | 6MG | open |
| 208684 · 002 · RLD | tablet, oral | 18MG | open |
| 208684 · 003 · RLD | tablet, oral | 30MG | open |
| 208684 · 004 · RLD | tablet, oral | 36MG | open |
| 208685 · 001 · RLD | suspension, oral | 22.75MG/ML | open |
Expired or delisted (1)
- ODE-252 · 7 Jun 2026