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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Citi
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McKesson
Johnson and Johnson
Express Scripts
Julphar
Queensland Health
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Generated: July 22, 2018

DrugPatentWatch Database Preview

AMOXICILLIN; CLAVULANATE POTASSIUM - Generic Drug Details

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What are the generic sources for amoxicillin; clavulanate potassium and what is the scope of amoxicillin; clavulanate potassium patent protection?

Amoxicillin; clavulanate potassium
is the generic ingredient in nine branded drugs marketed by Aurobindo Pharma Ltd, Hikma Pharms, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Wockhardt Bio Ag, Dr Reddys Labs Inc, Apotex Inc, Micro Labs Ltd India, and Teva Pharms Usa, and is included in forty-one NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Amoxicillin; clavulanate potassium has ninety-six patent family members in forty-eight countries.

There are forty-six drug master file entries for amoxicillin; clavulanate potassium. Forty-eight suppliers are listed for this compound.
Summary for AMOXICILLIN; CLAVULANATE POTASSIUM
International Patents:96
US Patents:5
Tradenames:9
Applicants:11
NDAs:41
Drug Master File Entries: 46
Suppliers / Packagers: 48
Bulk Api Vendors: 4
Clinical Trials: 17
Patent Applications: 289
DailyMed Link:AMOXICILLIN; CLAVULANATE POTASSIUM at DailyMed
Pharmacology for AMOXICILLIN; CLAVULANATE POTASSIUM
Synonyms for AMOXICILLIN; CLAVULANATE POTASSIUM
2C16H19N3O5S.C8H8NO5.K
4-Oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3-(2-hydroxyethylidene)-7-oxo-, monopotassium salt, (2R-(2-alpha,3Z,5-alpha))-, mixt. with (2S-(2-alpha,5-alpha,6-beta(S*)))-6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dime
4-Oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3-(2-hydroxyethylidene)-7-oxo-, monopotassium salt, (2R,3Z,5R)-, mixt. with (2S,5R,6R)-6-(((2R)-amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.
4-Oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3-(2-hydroxyethylidene)-7-oxo-,monopotassium salt, (2R-(2-alpha,3Z,5-alpha))-, mixt. with (2S-(2-alpha,5-alpha,6-beta(S*)))-6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimet
74428-36-7
74469-00-4
79198-29-1 (parent)
Amocla
Amoclan
Amoclav
Amoxi-Clavulanate
Amoxicillin / clavulanic acid
Amoxicillin clavulanate potassium
Amoxicillin mixed with potassium clavulanate (2:1)
Amoxicillin mixture with Clavulanate potassium
Amoxicillin-Clavulanic Acid
Amoxicillin-potassium clavulanate combination
Amoxsiklav
Amoxycillin-Clavulanic Acid
Ancla
Augmentan
AUGMENTIN '250'
Augmentin (antibiotic)
Augmentin XR
Augmentine
Auspilic
BRL 25000
BRL 25000A
BRL 25000G
BRL-25000
CHEMBL1697738
Clamentin
Clamobit
Clavam 625
Clavamox
Clavinex
Clavoxilin Plus
Clavulanate Potentiated Amoxycillin
Clavulin
Clavumox
Co-amoxiclav
Coamoxiclav
DTXSID40225477
DWHGNUUWCJZQHO-ZVDZYBSKSA-M
Eumetinex
HE385305
Kmoxilin
LS-187831
LS-98547
Potassium clavulanate mixed with amoxicillin (1:2)
Potassium Clavulanate-Amoxicillin Combination
SCHEMBL240728
Spectramox
Spektramox
Viaclav
Xiclav

US Patents and Regulatory Information for AMOXICILLIN; CLAVULANATE POTASSIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065066-002 Jun 5, 2002 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hikma Pharms AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 203824-001 Aug 23, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 065317-003 Oct 20, 2008 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dr Reddys Labs Inc AUGMENTIN '250' amoxicillin; clavulanate potassium TABLET;ORAL 050564-001 Aug 6, 1984 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Non-Orange Book US Patents for AMOXICILLIN; CLAVULANATE POTASSIUM

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
6,294,199 Method of treating a bacterial infection comprising administering amoxycillin ➤ Try a Free Trial
6,660,299 Modified release pharmaceutical formulation comprising amoxycillin ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
Argus Health
Fuji
Citi
Chinese Patent Office
McKinsey
Accenture
Cantor Fitzgerald

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.