mesalamine · Mylan Speciality Lp · NDA 019618
Sfrowasa
Earliest generic entry, as listed
24 Jul 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7645801.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7645801 | substance, product | 24 Jul 2027 |
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
- 24 Oct 2026Enters 12-month window basis: patent · 019618-00224 Jul 2027
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019618 · 002 · RLD · discontinued | enema, rectal | 4GM/60ML | 24 Jul 2027 |