Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

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Famotidine - Generic Drug Details

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What are the generic drug sources for famotidine and what is the scope of patent protection?

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-nine 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. One hundred and six suppliers are listed for this compound. There are five tentative approvals for this compound.

Drug Prices for famotidine

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

SponsorPhase
Dong-A ST Co., Ltd.N/A
Duke UniversityPhase 4
University of WashingtonPhase 2

See all famotidine clinical trials

Recent Litigation for famotidine

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13
Forest Laboratories LLC v. Sigmapharm Laboratories LLC2014-09-03
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 Trial10MG/MLInjectable; Injection
  Start Trial  Start Trial10MG/MLInjectable; Injection
  Start Trial  Start Trial10MG/MLInjectable; 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
Medical Subject Heading (MeSH) Categories for famotidine
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-((Diaminomethylene)amino)thiazol-4-yl)methyl)thio)-N'-sulfamoylpropanimidamide
3-(((2-guanidinothiazol-4-yl)methyl)thio)-N-sulfamoylpropanimidamide
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
AC1NWASH
AC1Q50E0
AC1Q50E1
AKOS005460541
AKOS015994617
AKOS030573443
Amfamox
Antodine
Apo-Famotidine
Apogastine
BC203224
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 (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
MolPort-002-557-620
MolPort-003-941-395
MolPort-006-069-255
Mosul
Motiax
Muclox
Mylanta AR
N inverted exclamation marka-(Aminosulfonyl)-3-([2-(diaminomethyleneamino)-4-thiazolyl]methylthio)propanamidine
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
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
TL8005267
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Carlsbad FAMOTIDINE famotidine TABLET;ORAL 075805-002 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 Y   Start Trial
Apotex Inc FAMOTIDINE famotidine INJECTABLE;INJECTION 075942-001 Aug 2, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd FAMOTIDINE PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 078642-001 Jun 25, 2008 AP RX 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck PEPCID RPD famotidine TABLET, ORALLY DISINTEGRATING;ORAL 020752-002 May 28, 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
Valeant Pharms North PEPCID famotidine TABLET;ORAL 019462-002 Oct 15, 1986   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verifification 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.