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Zyrtec generic
About Zyrtec
Zyrtec (cetirizine) — originally marketed by Generic (originally UCB Pharma). Class: Second-generation antihistamine. First approved 1995-09-29.
Approved generic versions (6)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE | marketed | 1995-01-01 | ||
| cetirizine 10 mg | Maastricht University Medical Center | marketed | ||
| Cetirizine and Famotidine | Emory University | marketed | ||
| Cetirizine (Zyrtec) | Organon and Co | marketed | ||
| Cetirizine tablets | UCB Pharma | marketed | ||
| Cetirizine drops | UCB Pharma | marketed |
Originator patent timeline
Active patents (0)
Expired patents (0)
How small-molecule generic approval works
Generic versions of small-molecule drugs are approved by the FDA via the Abbreviated New Drug Application (ANDA) pathway under the Hatch-Waxman Act of 1984. Sponsors must demonstrate bioequivalence (pharmacokinetic equivalence within tight bounds) and identical chemical composition — no clinical trials in patients are required. Approval typically takes 18-24 months.
This is different from biosimilars for biologic drugs, which use the more complex 351(k) BLA pathway and typically achieve smaller (15-35%) discounts vs the originator. Small-molecule generics typically launch at 60-80% discount, dropping to 85-95% within 2 years.
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Related
- Zyrtec full drug profile
- Biosimilar tracker (for biologic drugs)
- Patent cliff tracker
- Biosimilar vs generic — what's the difference?
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing