polyethylene glycol 3350 · Bayer Healthcare Llc · NDA 022015
Miralax
Earliest generic entry, as listed · earliest of 2 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 · 022015-00129 Jul 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022015 · 001 · RLD | for solution, oral | 17GM/SCOOPFUL | open |
| 022015 · 002 · RLD | for solution, oral | 17GM/PACKET | open |