Viewing data from:

RIMACTANE

NDA

RIFAMPIN | N050429 | OXFORD PHARMACEUTICALS LLC

1 strength0 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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lachman Consultant Services, Inc. - Citizen Petition FDA-2008-P-0662 · 2 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Rifampin Oral Suspension in strengths of 50 mg/5 mL and 100 mg/5 mL suitable for consideration in an abbreviated new drug application under Section 505(j)(2)(C), using Rifadin Capsules 300 mg	505(q)	2008-12-31	Open	—

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

Clinical Trials

180 trials from ClinicalTrials.gov — 2 recruiting, 153 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Rifampin in CYP24A1-related Hypercalcemia and Hypercalciuria NCT03301038	Phase 2	Recruiting	Children's Hospital of Philadelphia	60	2018-07-25 → 2030-12
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI NCT03474029	Phase 2/3	Recruiting	Centers for Disease Control and Prevention	3,400	2019-08-01 → 2029-12-31
Drug-drug Interaction Study of Ozanimod With Inhibitor or Inducer of CYP2C8 and/or CYP3A NCT03624959	Phase 1	Completed	Celgene	100	2018-06-20 → 2018-08-10
Drug-Drug Interaction Study in Healthy Adult Volunteers NCT02275962	Phase 1	Completed	Kowa Research Institute, Inc.	20	2014-09 → 2015-05
Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers NCT01231542	Phase 1	Completed	ViiV Healthcare	27	2011-05 → 2011-12
Influence of Rifampin on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer NCT01324323	Phase 1	Completed	Celgene	14	2011-04-01 → 2012-03-01
A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast NCT01561963	Phase 1	Completed	Amgen	21	2012-02-01 → 2012-04-01
Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia NCT02554318	N/A	Completed	University of Giessen	147	2013-11 → 2015-02
Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection NCT00000636	N/A	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	2,000	— → 1997-10
Estimation Of Effect Of Rifampin On Pharmacokinetics Of Crizotinib In Healthy Volunteers NCT01147055	Phase 1	Completed	Pfizer	15	2010-07 → 2010-10

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

API Supply Chain4 active DMFs5 inactive

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

LUPIN LTDRIFAMPIN USP

DMF 132141998

EUROAPI ITALY SRLRIFAMPIN, USP

DMF 133831998

CKD BIO CORPRIFAMPIN

DMF 136631998

OLON SPARIFAMPIN

DMF 137961998

SYNTHO RIFA PVT LTDInactiveRIFAMPIN

DMF 76031988

SOLCHEM ITALIANA S P AInactiveRIFAMPIN

DMF 100271992

NOVARTIS PHARMACEUTICALS CORPInactiveRIFAMPIN

DMF 133981998

SICHUAN LONG MARCH PHARMACEUTICAL CO LTDInactiveRIFAMPIN

DMF 136441998

FERMIC SA DE CVInactiveRIFAMPIN

DMF 137171998

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Aug 17, 2023	SUPPL -87	View Letter (PDF)
Feb 13, 2019	SUPPL -86	View Letter (PDF)
Dec 2, 2004	SUPPL -83	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.