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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: November 14, 2019

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Amoxicillin - Generic Drug Details

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

Amoxicillin is the generic ingredient in twenty-two branded drugs marketed by Am Antibiotics, Aurobindo, Dava Pharms Inc, Hikma Pharms, Labs Atral, Mylan, Sandoz, Sun Pharm Inds Ltd, Teva, Glaxosmithkline, Neopharma, Apothecon, Parke Davis, Wyeth Ayerst, Aurobindo Pharma Ltd, Hikma, Wockhardt Bio Ag, Pragma, Ranbaxy Labs Ltd, Ani Pharms Inc, Rising, Sandoz Inc, Takeda Pharms Usa, Cumberland Pharms, Apotex Inc, Micro Labs Ltd India, and Teva Pharms Usa, and is included in one hundred and fourteen NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amoxicillin has thirty-seven patent family members in six countries.

There are forty-six drug master file entries for amoxicillin. Thirty-six suppliers are listed for this compound.

Drug Prices for amoxicillin

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Drug Sales Revenue Trends for amoxicillin

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Recent Clinical Trials for amoxicillin

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

SponsorPhase
Infan Industria Quimica Farmaceutica NacionalPhase 2/Phase 3
Hospital Universitário Oswaldo CruzPhase 2/Phase 3
Uppsala UniversityPhase 4

See all amoxicillin clinical trials

Pharmacology for amoxicillin
Medical Subject Heading (MeSH) Categories for amoxicillin
Synonyms for amoxicillin
(-)-6-(2-Amino-2-(P-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo-(3.2.0)heptane-2-carboxylic acid
(2S,5R,6R)-6-((R)-2-Amino-2-(4-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
(2S,5R,6R)-6-[(2R)-2-amino-2-(4-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
(2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
(2S,5R,6R)-6-{[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
1236363-38-4
26787-78-0
33911-69-2
34642-77-8 (mono-hydrochloride salt)
4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 6-(((2R)-amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, (2S,5R,6R)-
4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-
4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, (2S-(2alpha,5alpha,6beta(S*)))-
4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 6-(2-amino-2-(p-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-, D-
4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 6-(2-amino-2-(p-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-, D- (8CI)
4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 6-[[amino (4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-, [2S-[2.alpha.,5.alpha.,6.beta.(S*)]]-
4-Thia-1-azobicyclo(3.2.0)heptane-2-carboxylic acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, (2S-(2alpha,5alpha,6beta(S)))-
6-(D-(-)-alpha-Amino-p-hydroxyphenylacetamido)penicillanic acid
6-(D-(-)-p-Hydroxy-alpha-aminobenzyl)penicillin
6-(p-Hydroxy-alpha-aminophenylacetamido)penicillanic acid
61336-70-7 (TRIHYDRATE)
6beta-[(2R)-2-amino-2-(4-hydroxyphenyl)acetamido]-2,2-dimethylpenam-3alpha-carboxylic acid
71447-36-4
81030-75-3
9EM05410Q9
AC-12263
AC1L1PY2
Actimoxi
Actimoxi, Alphamox, Amocla,Tycil, Amoxil, Trimox, among others
AJ-75350
AK102424
AKOS025395540
alpha-Amino-p-hydroxybenzylpenicillin
Amoclen
Amolin
Amopen
Amopenixin
AMOX
Amoxi
Amoxi-Inject
Amoxi-Mast
Amoxi-Tabs
Amoxibiotic
Amoxicaps
Amoxicilina
Amoxicilina [INN-Spanish]
amoxicillanyl
Amoxicillin (Amoxycillin)
Amoxicillin (anhydrous)
Amoxicillin (INN)
Amoxicillin (TN)
Amoxicillin [INN]
Amoxicillin anhydrous
AMOXICILLIN CRYSTALLINE
AMOXICILLIN PEDIATRIC
Amoxicillin trihydrate
Amoxicillin, 96%
Amoxicillin, potency: >=900 mug per mg
Amoxicilline
Amoxicilline [INN-French]
Amoxicilline [INN]
Amoxicillinum
Amoxicillinum [INN-Latin]
Amoxiden
Amoxil
Amoxivet
amoxycilin
Amoxycillin
Amoxycillin Trihydrate
AMPC
AN-39271
Anemolin
Apo-Amoxi
Aspenil
AX
BC204303
BDBM50350464
Biomox
BL-P 1410
BLP 1410
BPBio1_000499
BRD-K55044200-001-03-9
BRD-K55044200-001-15-3
Bristamox
BRL-2333
BSPBio_000453
C06827
CAS-26787-78-0
CCG-220357
Cemoxin
CHEBI:2676
CHEBI:53712
CHEMBL1082
Clamoxyl
CPD000058707
CS-2612
D-(-)-alpha-Amino-p-hydroxybenzylpenicillin
D-2-Amino-2-(4-hydroxyphenyl)acetamidopenicillanic acid
D-Amoxicillin
D07452
DB01060
Delacillin
DisperMox
DS-3835
DSSTox_CID_17044
DSSTox_GSID_37044
DSSTox_RID_79299
DTXSID3037044
EC 248-003-8
Efpenix
EINECS 248-003-8
Epitope ID:114241
Epitope ID:116054
Flemoxin
FT-0602856
Hiconcil
Histocillin
HMS1569G15
HMS2096G15
HMS2231K23
HMS3259P17
HMS3713G15
HSDB 3204
HY-B0467A
Hydroxyampicillin
Ibiamox
Imacillin
KS-00000Q8R
Lamoxy
LS-149721
LSQZJLSUYDQPKJ-NJBDSQKTSA-N
MCULE-5710225015
Metafarma capsules
Metifarma capsules
MLS000028632
MLS002222248
MolPort-005-933-687
Moxacin
Moxal
Moxatag
NC00670
NCGC00016797-02
NCGC00094586-01
NCGC00179554-01
NE41275
NSC 277174
NSC277174
Ospamox
p-Hydroxyampicillin
Pamoxicillin
Piramox
Prestwick_713
Prestwick0_000357
Prestwick1_000357
Prestwick2_000357
Prestwick3_000357
Ro 10-8756
Robamox
s3015
SAM002264592
Sawamox PM
SC-13298
SCHEMBL3427
SMR000058707
SPBio_002374
SR-01000721886
SR-01000721886-2
ST24034193
Sumox
Tolodina
Tox21_111302
Tox21_111302_1
Unicillin
UNII-9EM05410Q9
Utimox
Vetramox
Wymox
ZINC3830215

US Patents and Regulatory Information for amoxicillin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Neopharma LAROTID amoxicillin FOR SUSPENSION;ORAL 062226-003 Approved Prior to Jan 1, 1982 AB RX No No   Start Trial   Start Trial   Start Trial
Teva AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065089-001 May 25, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Parke Davis UTIMOX amoxicillin CAPSULE;ORAL 062107-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 201090-001 Dec 20, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Wockhardt Bio Ag AMOXICILLIN amoxicillin FOR SUSPENSION;ORAL 065319-002 Jun 18, 2007 AB 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

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Serving leading biopharmaceutical companies globally:

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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.