pantoprazole sodium · Wyeth Pharms · NDA 020988
Protonix Iv
Earliest generic entry, as listed
12 Aug 2027
Blocked by exclusivity: NPP.
FDA has approved 1 generic application (ANDA) for Protonix Iv, though its earliest generic-entry date is 12 Aug 2027 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| NPP | new patient population | 12 Aug 2027 |
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 219973, Shuangcheng · 020988-001Approved 22 Apr 2026Detected 25 Oct 2026Historical import
- Enters 12-month window basis: exclusivity · 020988-001Listed date 12 Aug 2027Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020988 · 001 · RLD | injectable, intravenous | EQ 40MG BASE/VIAL | 12 Aug 2027 |