sucralfate · Abbvie · NDA 018333, 019183
Carafate
Earliest generic entry, as listed
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 216758, Novitium Pharma · 019183-001Approved 14 Oct 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 212141, Glenmark Pharms Ltd · 019183-001Approved 5 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018333 · 001 · RLD | tablet, oral | 1GM | open |
| 019183 · 001 · RLD · discontinued | suspension, oral | 1GM/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |