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Zyrtec generic

Complete generic competition for Zyrtec (cetirizine): 6 approved generics across manufacturers, 0 filed under FDA review. Sourced from FDA Orange Book + USPTO.

6 approved generics Patents expired

About Zyrtec

Zyrtec (cetirizine) — originally marketed by Generic (originally UCB Pharma). Class: Second-generation antihistamine. First approved 1995-09-29.

Approved generic versions (6)

GenericManufacturerPhaseFirst approvalCountry
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)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

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

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing