bisoprolol fumarate; hydrochlorothiazide · Teva Branded Pharm · NDA 020186
Ziac
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 219489, Unique Pharm · 020186-001Approved 24 Mar 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217922, Aurobindo Pharma Ltd · 020186-001Approved 21 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020186 · 001 · RLD | tablet, oral | 5MG;6.25MG | open |
| 020186 · 002 · RLD | tablet, oral | 10MG;6.25MG | open |
| 020186 · 003 · RLD | tablet, oral | 2.5MG;6.25MG | open |