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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 amoxicillin 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, Dr Reddys Labs Inc, Glaxosmithkline, Apothecon, Parke Davis, Wyeth Ayerst, Aurobindo Pharma Ltd, Hikma, Wockhardt Bio Ag, Vernalis R And D Ltd, Ranbaxy Labs Ltd, Rising Pharms Inc, Sandoz Inc, Teva Pharms Usa, Takeda Pharms Usa, Gastroentero, Apotex Inc, and Micro Labs Ltd India, and is included in one hundred and thirteen 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. Fifty-four suppliers are listed for this compound.

Summary for amoxicillin

International Patents:	37
US Patents:	11
Tradenames:	22
Applicants:	26
NDAs:	113
Drug Master File Entries:	46
Suppliers / Packagers:	54
Bulk Api Vendors:	51
Clinical Trials:	330
Patent Applications:	6,764
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for amoxicillin
DailyMed Link:	amoxicillin at DailyMed

Pharmacology for amoxicillin

Ingredient-type	Penicillins
Drug Class	Penicillin-class Antibacterial

Medical Subject Heading (MeSH) Categories for amoxicillin

Anti-Bacterial Agents

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-(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

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-(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-carbonyl

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 (TN)

Actimoxi, Alphamox, Amocla,Tycil, Amoxil, Trimox, among others

AJ-75350

AK102424

AKOS025395540

alpha-Amino-p-hydroxybenzylpenicillin

Alphamox (TN)

AM021423

Ambap26787-78-0

AMK (TN)

amocilline

Amoclen

Amoksibos (TN)

Amoksiklav (TN)

Amolin

Amopen

Amopenixin

AMOX

amoxcillin

Amoxi

Amoxi-Inject

Amoxi-Mast

Amoxi-Tabs

Amoxibiotic

Amoxibiotic (TN)

Amoxicaps

Amoxicilina

Amoxicilina (TN)

Amoxicilina [INN-Spanish]

amoxicillanyl

Amoxicillin (Amoxycillin)

Amoxicillin (anhydrous)

Amoxicillin (INN)

Amoxicillin (TN)

Amoxicillin [INN]

Amoxicillin anhydrous

AMOXICILLIN CRYSTALLINE

Amoxicillin hydrate

AMOXICILLIN PEDIATRIC

Amoxicillin trihydrate

Amoxicillin, potency: >=900 mug per mg

Amoxicilline

Amoxicilline [INN-French]

Amoxicilline [INN]

Amoxicillinum

Amoxicillinum [INN-Latin]

Amoxiclav (TN)

Amoxidal (TN)

Amoxiden

Amoxil

Amoxil (TN)

Amoxin (TN)

Amoxivet

amoxycilin

Amoxycillin

Amoxycillin Trihydrate

AMPC

AN-39271

Anemolin

Apo-Amoxi

Apo-Amoxi (TN)

Aspenil

Augmentin (TN)

AX

Bactox (TN)

BC204303

BDBM50350464

Betalaktam (TN)

Biomox

BL-P 1410

BLP 1410

BPBio1_000499

BRD-K55044200-001-03-9

Bristamox

BRL-2333

BSPBio_000453

C06827

CAS-26787-78-0

CCG-220357

Cemoxin

CHEBI:2676

CHEBI:53712

CHEMBL1082

Cilamox (TN)

Clamoxyl

CPD000058707

CS-2612

Curam (TN)

D-(-)-alpha-Amino-p-hydroxybenzylpenicillin

D-2-Amino-2-(4-hydroxyphenyl)acetamidopenicillanic acid

D-Amoxicillin

D07452

D0F6EO

DB01060

Dedoxil (TN)

Delacillin

DisperMox

Dispermox (TN)

DSSTox_CID_17044

DSSTox_GSID_37044

DSSTox_RID_79299

DTXSID3037044

Duomox (TN)

Efpenix

EINECS 248-003-8

Enhancin (TN)

Epitope ID:114241

Epitope ID:116054

Flemoxin

FT-0602856

Geramox (TN)

Gimalxina (TN)

HE064797

HE391015

Hiconcil

Hiconcil (TN)

Histocillin

HMS1569G15

HMS2096G15

HMS2231K23

HMS3259P17

HSDB 3204

HY-B0467A

Hydroxyampicillin

Ibiamox

Imacillin

Isimoxin (TN)

Klavox (TN)

KS-00000Q8R

Lamoxy

Lamoxy (TN)

Larotid

LS-149721

LSQZJLSUYDQPKJ-NJBDSQKTSA-N

MCULE-5710225015

Metafarma capsules

Metifarma capsules

MFCD00056860

MLS000028632

MLS002222248

MolPort-005-933-687

Moxacin

Moxal

Moxatag

Moxatag (TN)

Moxilen (TN)

Moxypen (TN)

Moxyvit (TN)

NC00670

NCGC00016797-02

NCGC00094586-01

NCGC00179554-01

NE41275

Nobactam (TN)

Novamoxin (TN)

NSC 277174

NSC277174

Ospamox

Ospamox (TN)

p-Hydroxyampicillin

Pamoxicillin

Pamoxicillin (TN)

Panamox (TN)

Panklav (TN)

Piramox

Polymox

Polymox (TN)

Prestwick_713

Prestwick0_000357

Prestwick1_000357

Prestwick2_000357

Prestwick3_000357

Ro 10-8756

Robamox

s3015

SAM002264592

Samthongcillin (TN)

Sandoz (TN)

Sawamox PM

SC-13298

SCHEMBL3427

Senox (TN)

Sinacilin (TN)

SMR000058707

SPBio_002374

SR-01000721886

SR-01000721886-2

ST24034193

Sumox

Tolodina

Tolodina (TN)

Tox21_111302

Tox21_111302_1

Trimox

Trimox (TN)

Unicillin

UNII-9EM05410Q9

Utimox

Vetramox

Wymox

Wymox (TN)

Yucla (TN)

Zerrsox (TN)

Zimox (TN)

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
Dr Reddys Labs Inc	AMOXIL	amoxicillin	TABLET;ORAL	050754-002	Jul 10, 1998		DISCN	Yes	No
Aurobindo Pharma Ltd	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	201090-002	Dec 20, 2011	AB	RX	No	No
Aurobindo Pharma Ltd	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	091568-001	Jan 20, 2012	AB	RX	No	No
Micro Labs Ltd India	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	204755-003	Dec 30, 2016	AB	RX	No	No
Sandoz	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	065064-001	Mar 15, 2002	AB	RX	No	No

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Non-Orange Book US Patents for amoxicillin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,541,014	Antiviral product, use and formulation thereof
6,663,890	Metronidazole antibiotic product, use and formulation thereof
6,663,891	Erythromyacin antibiotic product, use and formulation thereof
6,667,042	Fluroquinilone antibiotic product, use and formulation thereof
6,667,057	Levofloxacin antibiotic product, use and formulation thereof

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International Patents for amoxicillin

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007067770
World Intellectual Property Organization (WIPO)	03086344
European Patent Office	1968586
Japan	2005523309
Canada	2494015