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

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Last Updated: November 21, 2019

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Cephalexin - Generic Drug Details

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

Cephalexin is the generic ingredient in five branded drugs marketed by Alkem Labs Ltd, Apothecon, Aurobindo Pharma Ltd, Barr, Belcher Pharms, Facta Farma, Hikma, Ivax Sub Teva Pharms, Lupin, Orchid Hlthcare, Purepac Pharm, Stevens J, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Yoshitomi, Yung Shin Pharm, Pragma, Hikma Pharms, Vitarine, Ranbaxy Labs Ltd, and Lilly, and is included in fifty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for cephalexin. Forty-five suppliers are listed for this compound.

Drug Prices for cephalexin

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Drug Sales Revenue Trends for cephalexin

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Recent Clinical Trials for cephalexin

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SponsorPhase
National Cheng-Kung University HospitalN/A
University of Colorado, DenverPhase 1
Ain Shams UniversityN/A

See all cephalexin clinical trials

Pharmacology for cephalexin
Medical Subject Heading (MeSH) Categories for cephalexin
Synonyms for cephalexin
(6R-(6alpha 7beta(R)))-7-((Aminophenylacetyl)amino)-3-methyl-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid
(6R,7R)-7-((R)-2-Amino-2-phenyl-acetylamino)-3-methyl-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid
(6R,7R)-7-((R)-2-amino-2-phenylacetamido)-3-methyl-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid
(6R,7R)-7-((R)-2-Amino-2-phenylacetamido)-3-methyl-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-en-2-carbonsaeure
(6R,7R)-7-((R)-2-amino-2-phenylacetamido)-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
(6R,7R)-7-[(2R)-2-amino-2-phenylacetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
(6R,7R)-7-[[(2R)-2-amino-2-phenyl-acetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
(6R,7R)-7-[[(2R)-2-amino-2-phenylacetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
(6R,7R)-7-{[(2R)-2-amino-2-phenylacetyl]amino}-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
105879-42-3 (mono-hydrochloride, mono-hydrate)
105879-42-3 (mono-hydrochloride,mono-hydrate)
14101-75-8
15686-71-2
17692-47-6
2312AH
23325-78-2 (mono-hydrate)
34632-04-7
38932-40-0 (mono-hydrochloride salt)
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-(((2R)-aminophenylacetyl)amino)-3-methyl-8-oxo-, (6R,7R)-
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((aminophenylacetyl)amino)-3-methyl-8-oxo-, (6R-(6alpha,7beta(R*)))-
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-(2-amino-2-phenylacetamido)-3-methyl-8-oxo-, D-
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2R)-2-amino-2-phenylacetyl]amino]-3-methyl-8-oxo-, (6R,7R)-
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2R)-aminophenylacetyl]amino]-3-methyl-8-oxo-, (6R,7R)-
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylicacid, 7-[[(2R)-2-amino-2-phenylacetyl]amino]-3-methyl-8-oxo-, (6R,7R)-
5SFF1W6677
65454-17-3
66905-57-5 (di-hydrate)
7-(D-2-Amino-2-phenylacetamido)-3-methyl-delta (sup 3)-cephem-4- carboxylic acid
7-(D-2-Amino-2-phenylacetamido)-3-methyl-delta3-cephem-4-carboxylic acid
7-(D-alpha-amino-phenylacetamido)-3-methyl-3-cepheme-4-carboxylic acid
7-(D-alpha-Aminophenylacetamido)desacetoxycephalosporanic acid
7-beta-(D-alpha-Amino-alpha-phenylacetylamino)-3-methyl-3-cephem-4-carboxylic acid
7beta-[(2R)-2-amino-2-phenylacetamido]-3-methyl-3,4-didehydrocepham-4-carboxylic acid
82853-18-7
AB0089169
AB2000126
AC1L1D8M
AK322021
AKOS004119846
Alcephin
Alexin
Alsporin
AN-18582
Anhydrous cefalexin
Anhydrous cephalexin
API0001883
B1692
BCP9000509
BCPP000289
BDBM50139896
Biocef
BPBio1_000501
BRD-K90733503-002-03-6
BRN 0965503
BSPBio_000455
C-2660
C06895
Carnosporin
CAS-15686-71-2
CCG-100831
Cefa-iskia
Cefablan
Cefadal
Cefadin
Cefadina
Cefaleksin
Cefalessina
Cefalessina [DCIT]
Cefalexin
Cefalexin (JP17)
Cefalexin [INN]
Cefalexin anhydrous
Cefalexin, British Pharmacopoeia (BP) Reference Standard
Cefalexin, VETRANAL(TM), analytical standard
Cefalexin,(S)
Cefalexin;Alcephin;Cefablan;keflex,Cefadin;Tepaxin
Cefalexina
Cefalexina [INN-Spanish]
Cefalexine
Cefalexine [INN-French]
Cefalexinum
Cefalexinum [INN-Latin]
Cefalin
Cefaloto
Cefaseptin
Cefax
Ceflax
Ceforal
Cefovit
Celexin
Cepastar
Cepexin
Cephacillin
Cephalexin (anhydrous)
Cephalexin (Cefalexin)
Cephalexin [USAN:BAN]
Cephalexin 1-hydrate
Cephalexin anhydrous
Cephalexin hydrate
Cephalexin hydrochloride
Cephalexin monohydrate
Cephalexin monohydrate, Antibiotic for Culture Media Use Only
Cephalexin, (6R-(6alpha,7beta))-Isomer
Cephalexin, Antibiotic for Culture Media Use Only
Cephalexin, Pharmaceutical Secondary Standard; Certified Reference Material
Cephalexine
Cephalexinum
Cephanasten
Cephaxin
Cephin
Cepol
Ceporex
Ceporex Forte
Ceporexin
Ceporexin-E
Ceporexine
Cerexin
Cerexins
CEX
CHEBI:3534
Check
CHEMBL1727
Cophalexin
CS-2137
CTK2F7346
D00263
DB00567
DS-11971
DSSTox_CID_2780
DSSTox_GSID_22780
DSSTox_RID_76726
DTXSID9022780
Durantel
Durantel DS
EBD56457
Ed A-Ceph
EINECS 239-773-6
Epitope ID:117132
Erocetin
Factagard
Felexin
Fexin
GTPL4832
HMS2051A04
HSDB 3022
HY-B0200
I06-2233
Ibilex
Ibrexin
Inphalex
Kefalospes
Keflet
Keflex
Keflex (TN)
Kefolan
Keforal
Keftab
Kekrinal
Kidolex
L-Cephalexin
L-Keflex
Lafarine
Larixin
Lenocef
Lexibiotico
Lilly 66873
Lonflex
Lopilexin
LS-149963
LS-174191
Madlexin
Mamalexin
Mamlexin
Medoxine
MFCD00056877
MLS000759527
MLS001424036
MolPort-002-507-304
NC00081
NCGC00159522-02
NCGC00159522-03
NCGC00159522-05
Neokef
Neolexina
Novolexin
Nufex
Optocef
Oracef
Oriphex
Oroxin
Ortisporina
Ospexin
Palitrex
Panixine Disperdose
Pectril
Prestwick0_000358
Prestwick1_000358
Prestwick2_000358
Prestwick3_000358
Pyassan
Q-200819
Roceph
Roceph Distab
S 6437
Sanaxin
Sartosona
SCHEMBL2961
Sencephalin
Sepexin
Servispor
Sialexin
Sinthecillin
SMR000338536
SPBio_002376
Sporicef
Sporidex
SQ 20248
Syncl
Syncle
Synecl
Tepaxin
Tokiolexin
Tox21_111740
Tox21_111740_1
UNII-5SFF1W6677
Uphalexin
Voxxim
Winlex
ZAIPMKNFIOOWCQ-UEKVPHQBSA-N
ZINC3830500
Zozarine

US Patents and Regulatory Information for cephalexin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma CEPHALEXIN cephalexin CAPSULE;ORAL 065215-002 Jan 24, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Vitarine CEPHALEXIN cephalexin TABLET;ORAL 062863-002 Aug 11, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Pragma KEFLEX cephalexin CAPSULE;ORAL 050405-002 Approved Prior to Jan 1, 1982 AB RX Yes No   Start Trial   Start Trial   Start Trial
Stevens J CEPHALEXIN cephalexin CAPSULE;ORAL 062869-001 Mar 17, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd CEPHALEXIN cephalexin FOR SUSPENSION;ORAL 065081-001 Jul 27, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Teva CEPHALEXIN cephalexin FOR SUSPENSION;ORAL 062767-001 Jun 16, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma Pharms CEPHALEXIN cephalexin FOR SUSPENSION;ORAL 065444-001 Aug 28, 2009 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

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