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ALLOPURINOL

NDA

ALLOPURINOL | N018241 | WATSON LABORATORIES INC

2 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Allan M. Green, M.D., LLC- Citizen Petition FDA-2011-P-0740 · 3 docket documents Allan M. Green, M.D., LLC filed this suitability petition pursuant to Section 505(j)(2)(C) requesting permission to submit an Abbreviated New Drug Application for allopurinol liquid suspension (100 mg/5mL) for oral administration, with a waiver of pediatric studies based on the reference listed drug	Other	2011-10-19	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

145 trials from ClinicalTrials.gov — 3 recruiting, 106 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass NCT04217421	Phase 3	Recruiting	dr. M.J.N.L. Benders	236	2020-02-14 → 2028-12-31
Uric Acid, Klotho and Salt Sensitivity in Young Adults Born Preterm NCT04026776	Early Phase 1	Recruiting	Wake Forest University Health Sciences	120	2020-09-02 → 2026-12
Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia NCT03150693	Phase 3	Recruiting	Alliance for Clinical Trials in Oncology	303	2017-09-20 → 2027-08
Study of Vitamin D and Uric Acid Lowering on Kidney and Blood Vessel Function NCT01320722	Phase 3	Completed	Brigham and Women's Hospital	242	2011-03 → 2015-06
RDEA3170 and Allopurinol Combination Study in Gout Subjects NCT02279641	Phase 1	Completed	Ardea Biosciences, Inc.	12	2014-11-01 → 2015-09-11
Allo HSCT Using RIC for Hematological Diseases NCT02661035	Phase 2	Completed	Masonic Cancer Center, University of Minnesota	156	2017-03-09 → 2023-05-29
Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia NCT00039130	Phase 2	Completed	Alliance for Clinical Trials in Oncology	105	2002-05 → 2014-10
Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?NCT00688480	Phase 4	Completed	A. D. Struthers	67	2008-01 → 2010-02
A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma NCT00000658	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	250	— → 1996-02
Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia NCT00061945	Phase 1/2	Completed	National Cancer Institute (NCI)	302	2003-06 → 2012-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain17 active DMFs11 inactive

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

TAPI NL BVALLOPURINOL

DMF 25061975

TAPI NL BVALLOPURINOL USP

DMF 28701977

SIGNA SA DE CVALLOPURINOL USP

DMF 158412002

MATRIX PHARMACORP PRIVATE LTDALLOPURINOL USP

DMF 164092003

UNION QUIMICO FARMACEUTICA SAALLOPURINOL

DMF 164722003

HARMAN FINOCHEM LTDALLOPURINOL

DMF 171282004

INDOCO REMEDIES LTDALLOPURINOL USP

DMF 212392008

IPCA LABORATORIES LTDALLOPURINOL USP

DMF 216762008

SCI PHARMTECH INCALLOPURINOL

DMF 248762011

UNICHEM LABORATORIES LTDALLOPURINOL USP

DMF 324292018

HETERO DRUGS LTDALLOPURINOL

DMF 354222020

EXEMED PHARMACEUTICALSALLOPURINOL USP

DMF 361132021

HALEOS LABS LTDALLOPURINOL

DMF 361302022

IOL CHEMICALS AND PHARMACEUTICALS LTDALLOPURINOL USP

DMF 371042023

SUPRIYA LIFESCIENCE LTDALLOPURINOL USP

DMF 395682024

HENAN DONGTAI PHARM CO LTDALLOPURINOL

DMF 397972024

ANHUI POLY PHARM CO LTDALLOPURINOL USP

DMF 401082024

DINAMITE DIPHARMA SPAInactiveALLOPURINOL

DMF 25341975

SIEGFRIED AGInactiveALLOPURINOL (BULK)

DMF 34801979

GANES CHEMICALS INC PENNSVILLE DIVInactiveALLOPURINOL, BULK FORM

DMF 35831979

EGIS PHARMACEUTICALS PRIVATE LTDInactiveALLOPURINOL

DMF 40841981

DIOSYNTH BVInactiveALLOPURINOL

DMF 49501983

ORGAMOL SAInactiveALLOPURINOL

DMF 52351984

FABBRICA ITALIANA SINTETICI SPAInactiveALLOPURINOL

DMF 63731986

RHONE-POULENC SANTE INCInactiveALLOPURINOL

DMF 64521986

LABORATORIO CHIMICO INTERNAZIONALE SPAInactiveALLOPURINOL

DMF 159452002

AXITEC CO LTDInactiveALLOPURINOL USP

DMF 178552004

PKU HEALTHCARE CORP LTDInactiveALLOPURINOL

DMF 239542010

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

Products (2)

Sort:

#001 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 16, 1984

No patent or exclusivity listings for this strength.

#002 — 300MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 16, 1984