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Seroquel generic
About Seroquel
Seroquel (quetiapine) — originally marketed by AstraZeneca.
Approved generic versions (10)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| 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)
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
- Seroquel 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