Viewing data from:

PIMOZIDE

ANDA

PIMOZIDE | A219897 | NOVITIUM PHARMA LLC

2 strengths0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

Today

CGT

Oct. 18, 2026

API Supply Chain3 active DMFs3 inactive

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

UNIMARK REMEDIES LTDPIMOZIDE USP [TYPE-2]

DMF 227472009

PH HEALTH LTDPIMOZIDE USP

DMF 254622011

VASUDHA PHARMA CHEM LTDPIMOZIDE USP

DMF 275832013

NV ORGANONInactivePIMOZIDE

DMF 84261990

JANSSEN RESEARCH FDNInactivePIMOZIDE

DMF 108721994

SAI LIFE SCIENCES LTDInactivePIMOZIDE USP

DMF 284952014

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

Products (2)

Sort:

#001 — 1MG

0 patents1 exclusivity▴

TABLET;ORAL | Approved: Apr 13, 2026

Code	Date	Status
CGT	Oct 18, 2026	< 1 year

#002 — 2MG

0 patents1 exclusivity▾

TABLET;ORAL | Approved: Apr 13, 2026

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

Orphan drug exclusivity added to pimozide (Novitium Pharma, NDA 219897) effective through the designated exclusivity expiration date.

New: New record

ADDED7/1/2026

Novitium Pharma's pimozide NDA 219897 gained a CGT (Competitive Generic Therapy) exclusivity designation as of this update.

New: New record