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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.
Summary for famotidine
| US Patents: | 7 |
| Tradenames: | 11 |
| Applicants: | 40 |
| NDAs: | 69 |
| Drug Master File Entries: | 18 |
| Suppliers / Packagers: | 106 |
| Bulk Api Vendors: | 62 |
| Clinical Trials: | 66 |
| Patent Applications: | 7,301 |
| 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 |
Recent Clinical Trials for famotidine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dong-A ST Co., Ltd. | N/A |
| Duke University | Phase 4 |
| University of Washington | Phase 2 |
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 |
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
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.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.