Famotidine - Generic Drug Details

» See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for famotidine and what is the scope of freedom to operate?

Famotidine is the generic ingredient in eleven branded drugs marketed by Hi-tech Pharma Co, Lupin Ltd, Navinta Llc, Novel Labs Inc, Salix Pharms, Apotex Inc, Apothecon, Athenex Inc, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, West-ward Pharms Int, Abbvie, Baxter Hlthcare, Merck, Merck Sharp Dohme, Perrigo, J And J Consumer Inc, Ucb Inc, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo Pharma Ltd, Carlsbad, Celltrion, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, P And L, Perrigo R And D, Pld Acquisitions, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Watson Labs, Wockhardt, Valeant Pharms North, and Horizon, and is included in sixty-eight NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for famotidine. Eighty-seven suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for famotidine

US Patents:	7
Tradenames:	11
Applicants:	40
NDAs:	68
Drug Master File Entries:	18
Suppliers / Packagers:	87
Bulk Api Vendors:	65
Clinical Trials:	72
Patent Applications:	7,309
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for famotidine
Drug Sales Revenues:	Drug sales revenues for famotidine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for famotidine
DailyMed Link:	famotidine at DailyMed

See drug prices for famotidine

Drug Sales Revenue Trends for famotidine

See drug sales revenues for famotidine

Recent Clinical Trials for famotidine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Northwell Health	Phase 3
Mayo Clinic	Phase 2
AstraZeneca	Phase 1

See all famotidine clinical trials

Recent Litigation for famotidine

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Purdue Pharmaceutical v. Actavis Elizabeth LLC	2015-05-13
Forest Laboratories LLC v. Sigmapharm Laboratories LLC	2014-09-03
CIMA Labs Inc. v. Barr Laboratories Inc.	2008-08-21

See all famotidine litigation

Generic filers with tentative approvals for FAMOTIDINE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	10MG/ML	Injectable; Injection
Start Trial	Start Trial	10MG/ML	Injectable; Injection
Start Trial	Start Trial	10MG/ML	Injectable; Injection

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for famotidine

Drug Class	Histamine-2 Receptor Antagonist
Mechanism of Action	Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for famotidine

Anti-Ulcer Agents
Histamine H2 Antagonists

Synonyms for famotidine

(1-Amino-3-(((2-((diaminomethylene)amino)-4-thiazolyl)methyl)thio)propylidene)sulfamide
(1Z)-2-amino-4-{[2-(2,2-diamino-1-azavinyl)(1,3-thiazol-4-yl)]methylthio}-1-az abut-1-enesulfonamide
(1Z)-3-[({2-[(diaminomethylidene)amino]-1,3-thiazol-4-yl}methyl)sulfanyl]-N'-sulfamoylpropanimidamide
(1Z)-N'-(aminosulfonyl)-3-[({2-[(diaminomethylidene)amino]-1,3-thiazol-4-yl}methyl)thio]propanimidamide
3-(((2-((Aminoiminomethyl)amino)-4-thiazolyl)methyl)thio)-N-(aminosulfonyl)propanimidamide
3-(((2-((Diaminomethylene)amino)-4-thiazolyl)methyl)thio)-N(sup 2)-sulfamoylpropionamidine
3-(((2-guanidinothiazol-4-yl)methyl)thio)-N-sulfamoylpropanimidamide
3-(2-(Diaminomethyleneamino)-1,3-thiazol-4-yl)methylthio)-N'- sulfamoylpropionamidine
3-[({2-[(Diaminomethylene)amino]-1,3-thiazol-4-yl}methyl)sulfanyl]-N'-sulfamoylpropanimidamide
3-[({2-[(diaminomethylidene)amino]-1,3-thiazol-4-yl}methyl)sulfanyl]-N-sulfamoylpropanimidamide
3-[({2-[(diaminomethylidene)amino]-1,3-thiazol-4-yl}methyl)sulfanyl]-N''-sulfamoylpropanimidamide
3-[(2-guanidinothiazol-4-yl)methylsulfanyl]-N-sulfamoyl-propanamidine
3-[[[2-[(Aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]-N-(aminosulfonyl)propanimidamide
3-[[2-(diaminomethylideneamino)-1,3-thiazol-4-yl]methylsulfanyl]-N'-sulfamoylpro
3-[2-(diaminomethyleneamino] thiazol-4-ylmethylthio]-N-sulphamoyl propionamidine
5QZO15J2Z8
76824-35-6
824F356
AB00383032_11
AB03031
AC-11713
AKOS005460541
AKOS015994617
Amfamox
Antodine
Apo-Famotidine
Apogastine
BDBM22891
BDBM50103514
Bestidine
BIDD:GT0759
Blocacid
BPBio1_000098
Brolin
BSPBio_000088
C8H15N7O2S3
CAS-76824-35-6
CCG-100767
CCG-220104
CCG-221801
Cepal
CHEBI:4975
CHEMBL902
cid_5702160
Confobos
CPD000058961
Cronol
CS-2445
Cuantin
D00318
Dibrit 40
Digervin
Dinul
Dipsin
Dispromil
Dispronil
Duovel
Durater
EU-0100497
Evatin
F 6889
F0530
Fadin
Fadine
Fadyn
Fagastine
Famo
Famocid
Famodar
Famodil
Famodin
Famodine
Famogard
Famonit
Famopsin
Famos
Famosan
Famotal
Famotep
Famotidina [Spanish]
Famotidine , 98%
Famotidine (JP17/USP/INN)
Famotidine (Pepcid)
Famotidine [USAN:BAN:INN:JAN]
Famotidine for system suitability, European Pharmacopoeia (EP) Reference Standard
FAMOTIDINE PRESERVATIVE FREE
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
Famotidine, British Pharmacopoeia (BP) Reference Standard
Famotidine, European Pharmacopoeia (EP) Reference Standard
Famotidine, Pharmaceutical Secondary Standard; Certified Reference Material
Famotidine, United States Pharmacopeia (USP) Reference Standard
Famotidinum [Latin]
Famotin
Famovane
Famowal
Famox
Famoxal
Famtac
Famulcer
Fanobel
Fanosin
Fanox
Farmotex
Ferotine
Fibonel
Fluxid
Fluxid (TN)
FO9
Fudone
Ganor
Gaster
Gastridan
Gastridin
Gastrion
Gastro
Gastrodomina
Gastrofam
Gastropen
Gastrosidin
H2 Bloc
Hacip
HMS1568E10
HMS2051A07
HMS2089I12
HMS2095E10
HMS2231I22
HMS3261D15
HMS3712E10
HS-0054
HSDB 3572
Huberdina
HY-B0377
InChI=1/C8H15N7O2S3/c9-6(15-20(12,16)17)1-2-18-3-5-4-19-8(13-5)14-7(10)11/h4H,1-3H2,(H2,9,15)(H2,12,16,17)(H4,10,11,13,14)
Ingastri
Invigan
K328
KM1798
L 643341
L003830
L013386
Lecedil
Logos
Lopac-F-6889
Lopac0_000497
LS-121117
MCULE-1972636463
Mensoma
MFCD00079297
Midefam
MK 208
MK-208
MLS000028583
MLS000758205
MLS001423994
Mosul
Motiax
Muclox
Mylanta AR
N-(Aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide
N-Sulfamoyl-3-((2-guanidinothiazol-4-yl)methylthio)propionamide
N'-(Aminosulfonyl)-3-([2-(diaminomethyleneamino)-4-thiazolyl]methylthio)propanamidine
NC00017
NCGC00015446-01
NCGC00015446-02
NCGC00015446-03
NCGC00015446-04
NCGC00015446-05
NCGC00015446-06
NCGC00018276-01
NCGC00018276-02
NCGC00093899-01
NCGC00093899-02
NCGC00093899-03
NCGC00188952-01
NCGC00261182-01
Neocidine
Nevofam
Notidin
Novo-Famotidine
Nu-Famotidine
Nulceran
Nulcerin
Panalba
PDSP1_000398
PDSP2_000396
PEPCID
Pepcid (TN)
Pepcid AC
Pepcid AC Gelcaps
PEPCID COMPLETE
PEPCID PRESERVATIVE FREE
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER
Pepcid RPD
Pepcidac
Pepcidin
Pepcidin Rapitab
Pepcidina
Pepcidine
Pepdif
Pepdine
Pepdul
Pepfamin
Peptan
Peptidin
Peptifam
Pepzan
Prestwick_212
Prestwick2_000104
Prestwick3_000104
Propanimidamide, 3-(((2-((aminoiminomethyl)amino)-4-thiazolyl)methyl)thio)-N-(aminosulfonyl)-
Propanimidamide, 3-[[[2-[aminoiminomethyl)amino]-4-thiazoyl]methyl]thio]-N-(aminosulfonyl)
Propanimidamide, N'-(aminosulfonyl)-3-(((2-((diaminomethylene)amino)-4-thiazolyl)methyl)thio)-
Purifam
Quamatel
Quamtel
Renapepsa
Restadin
Rogasti
Rubacina
s2078
SAM001247033
SBI-0050481.P003
SCHEMBL972
SCHEMBL974
Sedanium-R
Sigafam
SMR000058961
SR-01000075883
SR-01000075883-1
SR-05000001440
SR-05000001440-1
SR-05000001440-2
ST51001070
STK527689
Supertidine
Tairal
Tamin
Tipodex
Topcid
Tox21_500497
Ulcatif
Ulceprax
Ulcofam
Ulfagel
Ulfam
Ulfamid
Ulfinol
Ulgarine
UNII-5QZO15J2Z8
Vagostal
Weimok
Whitidin
XUFQPHANEAPEMJ-UHFFFAOYSA-
XUFQPHANEAPEMJ-UHFFFAOYSA-N
Yamarin
YM 11170
YM-11170
YM-1170

Paragraph IV (Patent) Challenges for FAMOTIDINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
PEPCID	TABLET;ORAL	famotidine	019462
PEPCID AC	TABLET, CHEWABLE;ORAL	famotidine	020801

US Patents and Regulatory Information for famotidine

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
West-ward Pharms Int	FAMOTIDINE PRESERVATIVE FREE	famotidine	INJECTABLE;INJECTION	075789-001	Apr 30, 2002		DISCN	No	No	Start Trial	Start Trial				Start Trial
Ivax Sub Teva Pharms	FAMOTIDINE	famotidine	TABLET;ORAL	075511-002	Apr 16, 2001	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Wockhardt	FAMOTIDINE	famotidine	TABLET;ORAL	090837-001	Aug 4, 2010		OTC	No	No	Start Trial	Start Trial				Start Trial
Dr Reddys Labs Ltd	FAMOTIDINE	famotidine	TABLET;ORAL	075718-001	Apr 16, 2001	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-002	Sep 24, 2004		DISCN	No	No	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for famotidine

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998	Start Trial	Start Trial
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-002	May 28, 1998	Start Trial	Start Trial
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998	Start Trial	Start Trial
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987	Start Trial	Start Trial
Merck	PEPCID PRESERVATIVE FREE	famotidine	INJECTABLE;INJECTION	019510-004	Nov 4, 1986	Start Trial	Start Trial
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998	Start Trial	Start Trial
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

By using our website you are consenting to our use of cookies in accordance with our privacy policy.