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NDA

ARIPIPRAZOLE | N021713 | OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expiring < 1yr (1)Today

2027

Today

8759350

Mar. 2, 2027

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
OTSUKA PHARMACEUTICAL CO., LTD. v. SILARX PHARMACEUTICALS, INC. 3:2012cv05809 1 patentANDA 204171aripiprazole	D.N.J.	2012-09-14	Terminated 2014-05-05	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain47 active DMFs11 inactive

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

ERREGIERRE SPAARIPIPRAZOLE USP-EP

DMF 187062005

CAMBREX CHARLES CITY INCARIPIPRAZOLE

DMF 187742005

MATRIX PHARMACORP PRIVATE LTDARIPIPRAZOLE USP

DMF 195542006

JUBILANT BIOSYS LTDARIPIPRAZOLE USP

DMF 197392006

ZYDUS LIFESCIENCES LTDARIPIPRAZOLE USP

DMF 198412006

OLON SPAARIPIPRAZOLE

DMF 199202006

TAPI NL BVARIPIPRAZOLE

DMF 199262006

APOTEX INCARIPIPRAZOLE USP

DMF 199572006

TAI HENG INDUSTRY CO LTDARIPIPRAZOLE

DMF 199822006

ORBION PHARMACEUTICALS PRIVATE LTDARIPIPRAZOLE (NON-STERILE BULK API)

DMF 219372008

HETERO LABS LTDARIPIPRAZOLE PROCESS II

DMF 225632009

SUVEN LIFE SCIENCES LTDARIPIPRAZOLE

DMF 228252009

NEULAND LABORATORIES LTDARIPIPRAZOLE USP (ANHYDROUS FORM - B)

DMF 228892009

ALEMBIC PHARMACEUTICALS LTDARIPIPRAZOLE USP

DMF 233002009

ZAKLADY FARMACEUTYCZNE POLPHARMA SAARIPIPRAZOLE

DMF 233142009

MSN PHARMACHEM PRIVATE LTDARIPIPRAZOLE USP [ROUTE CODE - "AL1"]

DMF 240902010

UNICHEM LABORATORIES LTDARIPIPRAZOLE USP

DMF 240982010

ULKAR KIMYA SANAYII VE TICARET ASARIPIPRAZOLE

DMF 249372011

APITORIA PHARMA PRIVATE LTDARIPIPRAZOLE USP (NON-STERILE DRUG SUBSTANCE)

DMF 249972011

MACLEODS PHARMACEUTICALS LTDARIPIPRAZOLE

DMF 254722012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDARIPIPRAZOLE USP

DMF 256852011

WOCKHARDT BIO AGARIPIPRAZOLE

DMF 267432013

ALKEM LABORATORIES LTDARIPIPRAZOLE USP

DMF 279092014

ZHEJIANG HISUN PHARMACEUTICAL CO LTDARIPIPRAZOLE USP

DMF 283412014

TOPHARMAN SHANDONG CO LTDARIPIPRAZOLE

DMF 285632014

MSN PHARMACHEM PRIVATE LTDARIPIPRAZOLE USP MONOHYDRATE [ROUTE CODE-HA]

DMF 291352015

CADILA PHARMACEUTICALS LTDARIPIPRAZOLE USP

DMF 296802015

SMS PHARMACEUTICALS LTDARIPIPRAZOLE USP

DMF 299912015

COHANCE LIFESCIENCES LTDARIPIPRAZOLE USP

DMF 301202015

RUYUAN HEC PHARM CO LTDARIPIPRAZOLE NON-STERILE BULK DRUG SUBSTANCE

DMF 309542016

MATRIX PHARMACORP PRIVATE LTDARIPIPRAZOLE MONOHYDRATE

DMF 312572016

HETERO LABS LTDARIPIPRAZOLE PROCESS-I

DMF 314552017

ZHEJIANG JINHUA CONBA BIO-PHARM CO LTDARIPIPRAZOLE USP

DMF 324472018

ZAKLADY FARMACEUTYCZNE POLPHARMA SAARIPIPRAZOLE MONOHYDRATE

DMF 332042018

APITORIA PHARMA PRIVATE LTDARIPIPRAZOLE USP (PROCESS II)

DMF 338272019

INDOCO REMEDIES LTDARIPIPRAZOLE USP

DMF 339622019

INTERQUIM SAARIPIPRAZOLE MONOHYDRATE

DMF 349692021

GLAND PHARMA LTDARIPIPRAZOLE MONOHYDRATE – STERILE

DMF 362602021

NEULAND LABORATORIES LTDARIPIPRAZOLE MONOHYDRATE (STERILE)

DMF 364512021

GLAND PHARMA LTDARIPIPRAZOLE LAUROXIL – STERILE

DMF 365222021

REYOUNG CORPORATIONARIPIPRAZOLE

DMF 367232022

SUN PHARMACEUTICAL INDUSTRIES LTDARIPIPRAZOLE USP

DMF 367742022

INTERQUIM SAARIPIPRAZOLE MONOHYDRATE STERILE

DMF 371842022

QILU PHARMACEUTICAL CO LTDARIPIPRAZOLE MONOHYDRATE (STERILE)

DMF 402142024

QILU PHARMACEUTICAL CO LTD (LAOLING SITE)ARIPIPRAZOLE

DMF 403362024

CHROMO LABORATORIES INDIA PRIVATE LTDARIPIPRAZOLE USP

DMF 407382025

SURAJ LABORATORIES PRIVATE LTDARIPIPRAZOLE USP

DMF 414582025

BRISTOL MYERS SQUIBB COInactiveARIPIPRAZOLE TABLETS

DMF 156512001

DR REDDYS LABORATORIES LTDInactiveARIPIPRAZOLE

DMF 184712005

IND SWIFT LABORATORIES LTDInactiveARIPIPRAZOLE

DMF 192032006

SYNTHON BVInactiveARIPIPRAZOLE

DMF 196822006

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveARIPIPRAZOLE

DMF 199492006

CIPLA LTDInactiveARIPIPRAZOLE

DMF 201892007

CADILA PHARMACEUTICALS LTDInactiveARIPIPRAZOLE

DMF 204642007

SMS PHARMACEUTICALS LTDInactiveARIPIPRAZOLE

DMF 223392008

ZHEJIANG JINHUA CONBA BIO-PHARM CO LTDInactiveARIPIPRAZOLE

DMF 259962012

MAPRIMED SAInactiveARIPIPRAZOLE

DMF 269212013

AMOLI ORGANICS PVT LTDInactiveARIPIPRAZOLE USP

DMF 291382015

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

Approval Letters

30 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2020	SUPPL -36	View Letter (PDF)
Feb 6, 2020	SUPPL -35	View Letter (PDF)
Aug 8, 2019	SUPPL -34	View Letter (PDF)
Mar 2, 2017	SUPPL -33	View Letter (PDF)
Aug 18, 2016	SUPPL -32	View Letter (PDF)
Jan 20, 2016	SUPPL -31	View Letter (PDF)
Dec 15, 2014	SUPPL -30	View Letter (PDF)
Jul 11, 2014	SUPPL -28	View Letter (PDF)
Aug 5, 2013	SUPPL -29	View Letter (PDF)
Feb 27, 2012	SUPPL -25	View Letter (PDF)
Mar 8, 2011	SUPPL -24	View Letter (PDF)
Feb 18, 2011	SUPPL -21	View Letter (PDF)
Dec 7, 2010	SUPPL -23	View Letter (PDF)
Dec 3, 2010	SUPPL -22	View Letter (PDF)
Jul 24, 2009	SUPPL -20	View Letter (PDF)
Aug 19, 2008	SUPPL -19	View Letter (PDF)
May 14, 2008	SUPPL -14	View Letter (PDF)
May 14, 2008	SUPPL -15	View Letter (PDF)
May 14, 2008	SUPPL -17	View Letter (PDF)
Mar 7, 2008	SUPPL -18	View Letter (PDF)
Feb 29, 2008	SUPPL -16	View Letter (PDF)
Nov 19, 2007	SUPPL -13	View Letter (PDF)
Nov 8, 2007	SUPPL -12	View Letter (PDF)
Oct 4, 2007	SUPPL -10	View Letter (PDF)
Oct 23, 2006	SUPPL -8	View Letter (PDF)
Sep 20, 2006	SUPPL -9	View Letter (PDF)
Feb 22, 2006	SUPPL -6	View Letter (PDF)
Jun 23, 2005	SUPPL -4	View Letter (PDF)
Mar 3, 2005	SUPPL -3	View Letter (PDF)
Dec 10, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▴

SOLUTION;ORAL | Approved: Dec 10, 2004

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8759350	Mar 2, 2027	—	—	—		—