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Amoxicillin - Generic Drug Details
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.
Summary for amoxicillin
| International Patents: | 37 |
| US Patents: | 11 |
| Tradenames: | 22 |
| Applicants: | 27 |
| NDAs: | 114 |
| Drug Master File Entries: | 46 |
| Suppliers / Packagers: | 36 |
| Bulk Api Vendors: | 58 |
| Clinical Trials: | 397 |
| Patent Applications: | 7,001 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for amoxicillin |
| Drug Sales Revenues: | Drug sales revenues for amoxicillin |
| DailyMed Link: | amoxicillin at DailyMed |
Recent Clinical Trials for amoxicillin
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Infan Industria Quimica Farmaceutica Nacional | Phase 2/Phase 3 |
| Hospital Universitário Oswaldo Cruz | Phase 2/Phase 3 |
| Uppsala University | Phase 4 |
Pharmacology for amoxicillin
| Drug Class | Penicillin-class Antibacterial |
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 |
International Patents for amoxicillin
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2006500344 | Start Trial |
| European Patent Office | 1969134 | Start Trial |
| Australia | 2003257176 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03086344 | Start Trial |
| Australia | 2003262626 | Start Trial |
| >Country | >Patent Number | >Estimated 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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ISSN: 2162-2639
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Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.