FDA Orange Book · active-ingredient family
Clozapine
Clozapine: 3 brands, 13 generics; first approved Sep 26, 1989; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
13
Listed patents
1
Next patent expiry
May 01, 2028
in 1 yr 9 mo
Brand (NDA) products
Originator applications
- DOUGLAS PHARMSNDA 2034792013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML SUSPENSION ORAL Rx — - FAZACLO ODTRLDJAZZNDA 02159020076 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 100MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 50MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 12.5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 150MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 200MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - CLOZARILRLDHERITAGE LIFENDA 01975819894 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 50MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued —
Generic (ANDA) products (13)
Abbreviated applications
- CLOZAPINEAUROBINDO PHARMAANDA 21292320245 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 25MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 100MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 150MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 200MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - CLOZAPINEBARR LABS INCANDA 09030820185 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 100MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 12.5MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 150MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 200MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - CLOZAPINEZYDUS PHARMSANDA 20948020174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - CLOZAPINEAUROBINDO PHARMAANDA 20643320164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - CLOZAPINEACCORD HLTHCAREANDA 20287320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - CLOZAPINEDR REDDYS LABS SAANDA 20380720154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - CLOZAPINEMYLANANDA 20182420154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 100MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 150MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 200MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - CLOZAPINEMYLANANDA 07541720105 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Discontinued — 50MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - CLOZAPINEIVAX SUB TEVA PHARMSANDA 07680920053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CLOZAPINEPAR PHARMANDA 07516220052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CLOZAPINEIVAX SUB TEVA PHARMSANDA 07494920034 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Rx — 50MG TABLET ORAL Rx AB - CLOZAPINESUN PHARM INDS INCANDA 07571320024 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - CLOZAPINESANDOZANDA 07454619962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8057811 | in 1 yr 9 mo | Product |
Approval history
FDA approval span
First approval
37 yr 5 mo ago
Most recent approval
1 yr 8 mo ago
Approvals span 1989–2024 across 16 FDA applications.
Brand (NDA) 319%
Generic (ANDA) 1381%
Clozapine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
