valganciclovir hydrochloride · Cheplapharm · NDA 021304, 022257
Valcyte
Earliest generic entry, as listed
11 Dec 2027
Blocked by patent: US 8889109, US 9642911.
FDA has approved 1 generic application (ANDA) for Valcyte, though its earliest generic-entry date is 11 Dec 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 · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8889109 | product | 11 Dec 2027 |
| US 9642911 | product | 11 Dec 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
- 25 Oct 2026Generic approved · 022257-00119 Mar 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021304 · 001 · RLD · discontinued | tablet, oral | EQ 450MG BASE | open |
| 022257 · 001 · RLD | for solution, oral | 50MG/ML | 11 Dec 2027 |