hydrochlorothiazide; olmesartan medoxomil · Cosette · NDA 021532
Benicar Hct
Earliest generic entry, as listed · earliest of 3 marketed strengths
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 206371, Micro Labs · 021532-002Approved 13 Apr 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 208465, Sciegen Pharms · 021532-002Approved 31 Mar 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217398, Msn · 021532-002Approved 26 Sep 2025Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021532 · 002 · RLD | tablet, oral | 12.5MG;20MG | open |
| 021532 · 003 · RLD | tablet, oral | 12.5MG;40MG | open |
| 021532 · 005 · RLD | tablet, oral | 25MG;40MG | open |