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
- Generic approved · ANDA 220042, Zydus Lifesciences · 208685-001Approved 3 Oct 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217173, Amneal · 208684-001Approved 12 Dec 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217103, Teva Pharms Inc · 208684-001Approved 19 Oct 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219930, Sun Pharm Inds Inc · 208685-001Approved 27 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220709, Biocon Pharma · 208685-001Approved 28 May 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220524, Hikma · 208684-001Approved 18 Sep 2026Detected 25 Oct 2026Historical import
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