amoxicillin; clarithromycin; lansoprazole · Takeda Pharms Usa · NDA 050757
Prevpac (Copackaged)
Earliest generic entry, as listed
Open now
No marketed reference-listed strength; date taken from all listed strengths.
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050757 · 001 · RLD · discontinued | capsule, tablet, capsule, delayed rel pellets, oral | 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |