Quetiapine (Seroquel)

Generics already compete: 15 makers on the market. 127 A-rated products from 15 makers substitute at the counter.

Seroquel was first approved by the FDA on 09/26/1997 under NDA 020639; the application holder is Cheplapharm Arzneimittel GMBH.

The latest NADAC for QUETIAPINE FUMARATE 200 MG TAB is $0.09 per unit (as of 10/28/2026).

Holder Cheplapharm Arzneimittel GMBHApplication NDA 020639Approved 09/26/1997

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Data as of 10/31/2026

Market protectionNone listedNo patent or exclusivity in the Orange Book Generics15 makersPriced in NADAC FDA shortageClearNot listedCurrent FDA list NADAC$0.09 / unitMid-priced of 7 strengths

01Patents and exclusivity

When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.

Latest patent: No Seroquel patent listed in the Orange Book

02Competition

Generics: 15 generic makers
First generic approved: 03/27/2012

Every listingEach listing and maker behind the generics count.

Price erosionHow NADAC moves as generics enter.

PrescribersWho prescribes it, from Medicare data.

Available in the full Quetiapine profile.See what is included

03Supply and price

FDA drug shortage: ClearNot on the current shortage list
NADAC: $0.09 per unitQUETIAPINE FUMARATE 200 MG TAB, mid-priced of 7 strengths, as of 10/28/2026

04Product

Application holder: Cheplapharm Arzneimittel GMBH
Application: NDA 020639
First approved: 09/26/1997
Dosage forms: tablet; tablet, extended release
Routes: oral
Other brand names: Seroquel XR

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.