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Seroquel generic

Complete generic competition for Seroquel (quetiapine): 10 approved generics across manufacturers, 0 filed under FDA review. Sourced from FDA Orange Book + USPTO.

10 approved generics Patents expired

About Seroquel

Seroquel (quetiapine) — originally marketed by AstraZeneca.

Approved generic versions (10)

GenericManufacturerPhaseFirst approvalCountry
Quetiapine or Risperidone + Aripiprazole Otsuka Pharmaceutical Development & Commercialization, Inc. marketed
Quetiapine 600mg AstraZeneca marketed
Quetiapine Fumarate Sustained Release AstraZeneca marketed
quetiapine, risperidone University of Texas Southwestern Medical Center marketed
Quetiapine (drug) Medical University of Vienna marketed
quetiapine fumarate extended-release AstraZeneca marketed
Quetiapine and Topiramate University of Cincinnati marketed
quetiapine fumarate vs risperidone AstraZeneca marketed
Quetiapine Immediate Release AstraZeneca marketed
quetiapine (Seroquel) XR Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc. 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