Viewing data from:

CLOZARIL

NDA

CLOZAPINE | N019758 | HERITAGE LIFE SCIENCES BARBADOS INC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Clozaril (2023)

Total Spending

$12.7M

Total Claims

8,395

Beneficiaries

616

Avg Cost/Unit

$14.07

Spending Trend

$15.9M(2019)→$16.1M(2020)→$14.1M(2021)→$13.3M(2022)→$12.7M(2023)

YoY Change:+4.2%

5yr CAGR:+1.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain12 active DMFs3 inactive

12 active API suppliers hold Drug Master Files for this ingredient.

MEDICHEM SACLOZAPINE

DMF 105341993

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDCLOZAPINE

DMF 111951994

CAMBREX PROFARMACO MILANO SRLCLOZAPINE

DMF 116921995

WUHAN SHIJI PHARMACEUTICAL CO LTDCLOZAPINE

DMF 198222006

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDCLOZAPINE

DMF 251822011

MATRIX PHARMACORP PRIVATE LTDCLOZAPINE USP

DMF 273792013

COHANCE LIFESCIENCES LTDCLOZAPINE USP

DMF 319992017

AURORE LIFE SCIENCES PRIVATE LTDCLOZAPINE USP

DMF 366452021

GLOBAL CALCIUM PRIVATE LTDCLOZAPINE USP

DMF 368692022

MANKIND PHARMA LTDCLOZAPINE USP

DMF 375402023

R L FINE CHEM PVT LTDCLOZAPINE

DMF 380712023

SMS PHARMACEUTICALS LTDCLOZAPINE USP

DMF 399132024

AREVIPHARMA GMBHInactiveCLOZAPINE

DMF 108621994

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENTInactiveCLOZAPINE

DMF 110981994

SELOC FRANCEInactiveCLOZAPINE

DMF 124011997

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

36 letters from Drugs@FDA

Date	Submission	Document
Jun 16, 2025	SUPPL -107	View Letter (PDF)
Feb 7, 2025	SUPPL -106	View Letter (PDF)
Sep 16, 2024	SUPPL -104	View Letter (PDF)
Dec 21, 2022	SUPPL -101	View Letter (PDF)
Nov 24, 2021	SUPPL -99	View Letter (PDF)
Aug 2, 2021	SUPPL -98	View Letter (PDF)
Feb 22, 2021	SUPPL -96	View Letter (PDF)
Feb 16, 2021	SUPPL -88	View Letter (PDF)
Apr 15, 2020	SUPPL -95	View Letter (PDF)
Jan 22, 2019	SUPPL -90	View Letter (PDF)
Mar 2, 2017	SUPPL -84	View Letter (PDF)
Jan 30, 2017	SUPPL -81	View Letter (PDF)
Dec 22, 2016	SUPPL -80	View Letter (PDF)
Oct 13, 2015	SUPPL -78	View Letter (PDF)
Sep 22, 2015	SUPPL -74	View Letter (PDF)
Sep 16, 2015	SUPPL -77	View Letter (PDF)
Sep 16, 2015	SUPPL -61	View Letter (PDF)
Dec 23, 2014	SUPPL -73	View Letter (PDF)
Oct 1, 2014	SUPPL -72	View Letter (PDF)
Jul 22, 2013	SUPPL -69	View Letter (PDF)
Mar 25, 2013	SUPPL -67	View Letter (PDF)
Mar 25, 2013	SUPPL -68	View Letter (PDF)
Mar 25, 2013	SUPPL -70	View Letter (PDF)
Oct 24, 2011	SUPPL -63	View Letter (PDF)
Dec 6, 2010	SUPPL -65	View Letter (PDF)
Jan 26, 2010	SUPPL -62	View Letter (PDF)
Nov 6, 2008	SUPPL -53	View Letter (PDF)
Aug 19, 2008	SUPPL -59	View Letter (PDF)
Jul 1, 2008	SUPPL -58	View Letter (PDF)
Dec 13, 2005	SUPPL -57	View Letter (PDF)
Jun 29, 2005	SUPPL -56	View Letter (PDF)
May 17, 2005	SUPPL -54	View Letter (PDF)
Jun 1, 2004	SUPPL -47	View Letter (PDF)
Dec 24, 2003	SUPPL -51	View Letter (PDF)
Jul 5, 2002	SUPPL -48	View Letter (PDF)
Jan 14, 2002	SUPPL -45	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 25MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 26, 1989

No patent or exclusivity listings for this strength.

#002 — 100MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 26, 1989

#003 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 20, 2019

#004 — 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 20, 2019