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PEPCID AC

NDA

FAMOTIDINE | N020902 | JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV

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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 2 - Original Strength Pepcid AC Famotidine Tablets 10mg Acid Reduc... FDA-2023-P-5042 · 10 docket documents Tenshi Kaizen Private Limited filed a petition requesting FDA evaluation of the regulatory eligibility and suitability of Original Strength Pepcid AC Famotidine Tablets 10mg for over-the-counter use as an acid reducer, seeking confirmation that the product meets the criteria for OTC marketing author	Suitability	2023-11-15	Withdrawn	Tenshi Kaizen Private Limited

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

Clinical Trials

61 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 53 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia NCT03805932	Phase 1	Active	National Cancer Institute (NCI)	18	2019-10-03 → 2029-06-30
PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy NCT03647072	Phase 3	Recruiting	Sherief Abd-Elsalam	60	2018-08-01 → 2027-12
A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects NCT03302845	Phase 1	Completed	Lexicon Pharmaceuticals	32	2017-09-21 → 2017-11-07
Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis NCT02763969	Phase 1	Completed	Bristol-Myers Squibb	357	2016-05-18 → 2016-12-15
Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis NCT01563185	Phase 4	Completed	Amgen	12	2012-04 → 2015-03
Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer NCT03107182	Phase 2	Completed	University of Chicago	72	2017-06-27 → 2024-09-06
Pharmacokinetic and Safety Study of Cenicriviroc and Acid Reducing Agents When Dosed Alone or in Combination NCT02684799	Phase 1	Completed	Tobira Therapeutics, Inc.	48	2016-01-31 → 2016-04-11
Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)NCT02473042	N/A	Completed	M.D. Anderson Cancer Center	188	2016-03-01 → 2024-11-26
Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fasting Conditions NCT00802828	Phase 1	Completed	Perrigo Company	44	2004-06
Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin NCT01062516	Phase 4	Completed	Ruttonjee Hospital	100	2010-01 → 2010-09

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

API Supply Chain18 active DMFs9 inactive

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

ASTELLAS IRELAND CO LTDFAMOTIDINE

DMF 73561988

GEDEON RICHTER PLCFAMOTIDINE, USP

DMF 115371995

QUIMICA SINTETICA SAFAMOTIDINE

DMF 130361998

ERCROS SAFAMOTIDINE

DMF 130861998

DR REDDYS LABORATORIES LTDFAMOTIDINE USP

DMF 143091999

ZYDUS LIFESCIENCES LTDFAMOTIDINE USP

DMF 185242005

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)FAMOTIDINE USP

DMF 199112006

SMS PHARMACEUTICALS LTDFAMOTIDINE USP

DMF 214422008

ALEMBIC PHARMACEUTICALS LTDFAMOTIDINE USP

DMF 255812011

AZICO BIOPHORE INDIA PVT LTDFAMOTIDINE

DMF 355922021

HETERO DRUGS LTDFAMOTIDINE

DMF 356782021

MSN LIFE SCIENCES PRIVATE LTDFAMOTIDINE USP

DMF 356842021

NAKODA CHEMICALS LTDFAMOTIDINE USP

DMF 362952021

ORCHEV PHARMA PVT LTDFAMOTIDINE USP

DMF 367642022

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDFAMOTIDINE “YUNG SHIN”

DMF 368702022

MAHI DRUGS PRIVATE LTDFAMOTIDINE USP

DMF 374722023

APITORIA PHARMA PRIVATE LTDFAMOTIDINE USP

DMF 386432023

SMS LIFESCIENCES INDIA LTDFAMOTIDINE USP

DMF 389102023

ASTELLAS PHARMA INCInactiveFAMOTIDINE

DMF 57461985

DELMAR CHEMICALS INCInactiveFAMOTIDINE

DMF 81771989

QUIMICA SINTETICA SAInactiveFAMOTIDINE

DMF 90841991

WOCKHARDT LTDInactiveFAMOTIDINE USP

DMF 145301999

SREENIVASA PHARMA PRIVATE LTDInactiveFAMOTIDINE DRUG SUBSTANCE

DMF 152462001

APOTEX PHARMACHEM INCInactiveFAMOTIDINE USP

DMF 182542005

TONIRA PHARMA LTDInactiveFAMOTIDINE

DMF 193832006

DR REDDYS LABORATORIES LTDInactiveFamotidine (Form-A) USP

DMF 210422007

RICHTER THEMIS MEDICARE I PVT LTDInactiveFAMOTIDINE

DMF 248122011

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jun 12, 2006	SUPPL -9	View Letter (PDF)
Oct 29, 2004	SUPPL -7	View Letter (PDF)
Aug 5, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 5, 1999

No patent or exclusivity listings for this strength.