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AMPICILLIN SODIUM Drug Profile
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When do Ampicillin Sodium patents expire, and when can generic versions of Ampicillin Sodium launch?
Ampicillin Sodium is a drug marketed by Acs Dobfar Spa, Antibiotice, Apothecon, Aurobindo Pharma, Consolidated Pharm, Hanford Gc, Hospira Inc, Intl Medication, Istituto Bio Ita Spa, Lilly, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz, Watson Labs Inc, and West-ward Pharms Int. and is included in twenty-five NDAs.
The generic ingredient in AMPICILLIN SODIUM is ampicillin sodium. There are seventy drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
US ANDA Litigation and Generic Entry Outlook for Ampicillin Sodium
A generic version of AMPICILLIN SODIUM was launched as ampicillin sodium by SANDOZ on December 15th, 2019.
Summary for AMPICILLIN SODIUM
| US Patents: | 0 |
| Applicants: | 15 |
| NDAs: | 25 |
| Suppliers / Packagers: | 16 |
| Bulk Api Vendors: | 99 |
| Clinical Trials: | 8 |
| Patent Applications: | 4,079 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | AMPICILLIN SODIUM at DailyMed |
Recent Clinical Trials for AMPICILLIN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
| DongGuk University | N/A |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Pharmacology for AMPICILLIN SODIUM
| Drug Class | Penicillin-class Antibacterial |
Medical Subject Heading (MeSH) Categories for AMPICILLIN SODIUM
Synonyms for AMPICILLIN SODIUM
| (2S,5R,6R)-6-((R)-2-Amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid |
| (2s,5r,6r)-6-((r)-2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid |
| (2S,5R,6R)-6-[(2R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid |
| (2S,5R,6R)-6-[(R)-2-Amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid |
| (2S,5R,6R)-6-[[(2R)-2-amino-2-phenyl-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-phenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid sodium salt |
| (2S,5R,6R)-6-[[(2R)-2-amino-2-phenylacetyl]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-phenylacetyl]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-PHENYLETHANOYL]AMINO}-3,3-DIMETHYL-7-OXO-4-THIA-1-AZABICYCLO[3.2.0]HEPTANE-2-CARBOXYLIC ACID |
| 1h8s |
| 2S,5R,6R)-6-((R)-2-Amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid |
| 33604-21-6 |
| 37234-64-3 |
| 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 6-(((2R)-aminophenylacetyl)amino)-3,3-dimethyl-7-oxo-, (2S,5R,6R)- |
| 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 6-((aminophenylacetyl)amino)-3,3-dimethyl-7-oxo-, (2S-(2alpha,5alpha,6beta(S*)))- |
| 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 6-((aminophenylacetyl)amino)-3,3-dimethyl-7-oxo-, monosodium salt, (2S-(2alpha,5alpha,6beta(S*)))- |
| 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-, D-(-)- |
| 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-, sodium salt, D-(-)- |
| 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylicacid, 6-[[(2R)-2-amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-, (2S,5R,6R)- |
| 47355-94-2 |
| 50584-05-9 |
| 6-((2R)-2-amino-2-phenylacetylamino)(2S,5R,6R)-3,3-dimethyl-7-oxo-4-thia-1-aza bicyclo[3.2.0]heptane-2-carboxylic acid |
| 6-((2R)-2-amino-2-phenylacetylamino)(2S,5R,6R)-3,3-dimethyl-7-oxo-4-thia-1-aza bicyclo[3.2.0]heptane-2-carboxylic acid, oxamethane, oxamethane, oxamethane |
| 6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-,sodiumsalt,d-(-)-4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylicacid |
| 6-(a-Aminophenylacetamido)penicillanic acid |
| 6-(D-(2-Amino-2-phenylacetamido))-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid |
| 6-(D(-)-alpha-Aminophenylacetamido)penicillanic acid |
| 6-[(Aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 9CI |
| 6-D(-)-alpha-Aminophenylacetamido-penicillanic acid |
| 69-52-3 |
| 69-52-3 (mono-hydrochloride salt) |
| 69-52-3,24863-47-6,57748-55-7,69-53-4(freebase) |
| 69-53-4 |
| 69-53-4 (Parent) |
| 6beta-[(2R)-2-amino-2-phenylacetamido]-2,2-dimethylpenam-3alpha-carboxylic acid |
| 7177-48-2 (TRIHYDRATE) |
| 7C782967RD |
| 800-79-3 |
| 8056-87-9 |
| 96707-69-6 |
| 98520-55-9 |
| AB-PC |
| AB-PC Sol |
| ABPC |
| AC-8805 |
| AC-8806 |
| AC1L1M46 |
| Acillin |
| Adobacillin |
| AKOS015888156 |
| AKOS015967315 |
| AKOS025147373 |
| Alpen |
| Alpen-N |
| Alpha-Aminobenzylpenicillin |
| Amblosin |
| Amcill |
| Amcill-S |
| Amfipen |
| Amfipen V |
| Aminobenzylpenicillin |
| AMINOBENZYLPENICILLIN SODIUM SALT |
| Amipenix S |
| Ampen |
| AMPI |
| Ampi-bol |
| Ampi-Co |
| Ampi-Tab |
| Ampichel |
| Ampicil |
| Ampicilina |
| Ampicilina [INN-Spanish] |
| ampicillanyl |
| ampicillin |
| Ampicillin (anhydrous) |
| AMPICILLIN (SEE ALSO AMPICILLIN TRIHYDRATE 7177-48-2) |
| Ampicillin (sodium) |
| Ampicillin (USP/INN) |
| Ampicillin [USAN:BAN:INN:JAN] |
| Ampicillin [USAN:INN:BAN:JAN] |
| Ampicillin [USAN:USP:INN:BAN:JAN] |
| Ampicillin A |
| Ampicillin acid |
| Ampicillin anhydrate |
| Ampicillin Anhydrous |
| AMPICILLIN ANHYDROUS, PHARMACEUTICAL GRADE |
| Ampicillin Base |
| Ampicillin Na |
| Ampicillin natrium |
| Ampicillin sodium (JP17/USP) |
| Ampicillin sodium [USAN:USP:JAN] |
| Ampicillin sodium salt |
| Ampicillin Sodium Salt, Antibiotic for Culture Media Use Only |
| Ampicillin sodium salt, cell culture grade |
| Ampicillin, analytical standard |
| Ampicillin, anhydrous |
| Ampicillin, anhydrous, 96.0-100.5% (anhydrous basis) |
| Ampicillin, anhydrous, European Pharmacopoeia (EP) Reference Standard |
| Ampicillin, United States Pharmacopeia (USP) Reference Standard |
| Ampicillin,(S) |
| AMPICILLIN; D(-)-ALPHA-AMINOBENZYLPENICILLIN; 6-[D(-)-ALPHA-AMINOPHENYLLACETAMIDO]PENICILLANIC ACID |
| AMPICILLIN/AMPICILLIN TRIHYDRATE |
| Ampicillina |
| Ampicillina [DCIT] |
| Ampicilline |
| Ampicilline [INN-French] |
| Ampicillinsodium |
| Ampicillinum |
| Ampicillinum [INN-Latin] |
| Ampicin |
| Ampifarm |
| Ampikel |
| Ampimed |
| Ampipenin |
| Ampipenin, nt3 |
| Ampiplus Simplex |
| Ampiscel |
| Ampisyn |
| Ampivax |
| Ampivet |
| Amplacilina |
| Amplin |
| Amplipenyl |
| Amplisom |
| Amplital |
| Ampy-Penyl |
| AN-7670 |
| anhydrous ampicillin |
| Anhydrous ampicillin (JP17) |
| Anhydrous ampicillin, British Pharmacopoeia (BP) Reference Standard |
| API0001474 |
| Austrapen |
| AVKUERGKIZMTKX-NJBDSQKTSA-N |
| AY 6108 |
| AY 6108 |
| AY-6108 |
| BA 7305 |
| Bayer 5427 |
| BDBM50350465 |
| BIA0104 |
| BIDD:GT0184 |
| Binotal |
| Binotal sodium |
| Bonapicillin |
| BPBio1_000142 |
| BRD-K68432770-001-08-0 |
| Britacil |
| BRL 1341 |
| BRL-1341 |
| BSPBio_000128 |
| BSPBio_001862 |
| C-20591 |
| C-21155 |
| C06574 |
| C13652 |
| Campicillin |
| CAS-69-53-4 |
| CC-24106 |
| CC-24107 |
| CCG-39691 |
| CHEBI:28971 |
| CHEBI:34535 |
| CHEBI:53713 |
| CHEMBL1200758 |
| CHEMBL174 |
| Cimex |
| Citteral |
| Copharcilin |
| CPD000058352 |
| CS-2741 |
| CS-2742 |
| CTK2F3032 |
| D-(-)-.alpha.-Aminobenzylpenicillin |
| D-(-)-6-(alpha-Aminophenylacetamido)penicillanic acid |
| D-(-)-alpha-Aminobenzylpenicillin |
| D-(-)-alpha-Aminobenzylpenicillin sodium salt |
| D-(-)-alpha-Aminobenzylpenicillin sodium salt, cell culture grade |
| D-(-)-alpha-Aminopenicillin |
| D-(-)-Ampicillin |
| D-a-Aminobenzylpenicillin |
| D-Ampicillin |
| D-Cillin |
| D(-)-alpha-Aminobenzylpenicillin sodium salt |
| D00204 |
| D02119 |
| DB00415 |
| degrees +/-UEthCaA(1)EO AAENI |
| Delcillin |
| Deripen |
| Divercillin |
| DivK1c_000466 |
| Doktacillin |
| Domicillin |
| DSSTox_CID_2602 |
| DSSTox_GSID_22602 |
| DSSTox_RID_76654 |
| DTXSID4022602 |
| Duphacillin |
| EC 200-709-7 |
| EINECS 200-708-1 |
| EINECS 200-709-7 |
| Epitope ID:115008 |
| Epitope ID:116057 |
| FT-0602848 |
| Grampenil |
| Guicitrina |
| Guicitrine |
| HI 63 |
| HMS1920C21 |
| HMS2090I11 |
| HMS2091I21 |
| HMS2232J12 |
| HMS2233H23 |
| HMS501H08 |
| HSDB 3009 |
| HY-B0522 |
| HY-B0522A |
| IDI1_000466 |
| JFN36L5S8K |
| K161 |
| KBio1_000466 |
| KBio2_000430 |
| KBio2_002998 |
| KBio2_005566 |
| KBio3_001362 |
| KBioGR_000598 |
| KBioSS_000430 |
| KLOHDWPABZXLGI-YWUHCJSESA-M |
| KS-R1 |
| Lifeampil |
| LS-1586 |
| LS-169948 |
| Marcillin |
| MFCD00005175 |
| MFCD00064313 |
| MLS000028405 |
| MLS000028726 |
| MLS001074168 |
| MolPort-001-794-635 |
| MolPort-003-666-123 |
| Monosodium (2S,5R,6R)-6-((R)-2-Amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate |
| Monosodium D-(-)-6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate |
| Morepen |
| NCGC00018160-02 |
| NCGC00023282-05 |
| NCGC00023282-06 |
| NCGC00178944-03 |
| NCGC00248937-01 |
| NCGC00255127-01 |
| NINDS_000466 |
| Norobrittin |
| Novo-ampicillin |
| NSC 528986 |
| NSC-528986 |
| NSC528986 |
| Nuvapen |
| Olin Kid |
| Omnipen |
| OMNIPEN (AMPICILLIN) |
| Omnipen (TN) |
| Omnipen-N |
| Omnipen-N (TN) |
| Opera_ID_1630 |
| Opera_ID_709 |
| Orbicilina |
| P 50 |
| P-50 |
| Pen A |
| Pen A Oral |
| PEN A/N |
| Pen Ampil |
| Penbristol |
| Penbritin |
| Penbritin paediatric |
| Penbritin syrup |
| Penbritin-S |
| Penbrock |
| Penialmen |
| Penicillin, (aminophenylmethyl)- |
| Penicillin, Aminobenzyl |
| Penicline |
| Penimic |
| Pensyn |
| Pentrex |
| Pentrexl |
| Pentrexyl |
| Pentritin |
| Pfizerpen A |
| Pfizerpen-A |
| Polycillin |
| Polycillin-N |
| Polyflex (Veterinary) |
| Ponecil |
| Prestwick_822 |
| Prestwick0_000114 |
| Prestwick1_000114 |
| Prestwick2_000114 |
| Prestwick3_000114 |
| Princillin |
| Principen |
| Principen '125' |
| Principen '250' |
| Principen '500' |
| Principen/N |
| QIDamp |
| Racenacillin |
| Ro-Ampen |
| Rosampline |
| Roscillin |
| s3170 |
| SAM002564243 |
| SBB063111 |
| SBI-0051283.P003 |
| SCHEMBL3526 |
| SCHEMBL40521 |
| Semicillin |
| Semicillin R |
| Servicillin |
| SK-Ampicillin |
| SMP1_000211 |
| SMR000058352 |
| SMR000059229 |
| Sodium (2S-(2alpha,5alpha,6beta(S*)))-6-(aminophenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate |
| sodium (2S,5R,6R)-6-((R)-2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate |
| sodium (2S,5R,6R)-6-[[(2R)-2-amino-2-phenyl-acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate |
| sodium (2S,5R,6R)-6-{[(2R)-2-amino-2-phenylacetyl]amino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate |
| sodium 6beta-[(2R)-2-amino-2-phenylacetamido]-2,2-dimethylpenam-3alpha-carboxylate |
| Sodium amipicillin |
| Sodium ampicillin |
| sodium ampicillin(1-) |
| Sodium binotal |
| Sodium D-(-)-alpha-aminobenzylpenicillin |
| Sodium P-50 |
| sodium;(2S,5R,6R)-6-[[(2R)-2-amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate |
| SPBio_000818 |
| SPBio_002067 |
| Spectrum_000050 |
| SPECTRUM1500123 |
| Spectrum2_000769 |
| Spectrum3_000301 |
| Spectrum4_000149 |
| Spectrum5_000814 |
| SQ 17382 |
| ST077148 |
| Sultamicillin EP Impurity C |
| Sumipanto |
| Supen |
| SW220219-1 |
| Synpenin |
| Texcillin |
| Tokiocillin |
| Tolomol |
| Totacillin |
| Totacillin (sodium) |
| Totacillin-N |
| Totalciclina |
| Totapen |
| Tox21_113049 |
| Tox21_113049_1 |
| Tox21_301416 |
| Trifacilina |
| Ukapen |
| Ultrabion |
| Ultrabron |
| UNII-7C782967RD |
| UNII-JFN36L5S8K |
| VA10275 |
| VA10276 |
| Vampen |
| Viccillin |
| Viccillin (TN) |
| Viccillin S |
| Vidocillin |
| vidopen |
| WY-5103 |
| Wypicil |
| ZINC3830218 |
| ZX-AFC000780 |
US Patents and Regulatory Information for AMPICILLIN SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs Inc | AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 062816-003 | Oct 24, 1988 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Istituto Bio Ita Spa | AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 062719-002 | May 12, 1987 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hanford Gc | AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 062772-007 | Apr 15, 1993 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lilly | AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 062565-001 | Apr 4, 1985 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sagent Pharms Inc | AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 090583-003 | Nov 27, 2015 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Istituto Bio Ita Spa | AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 062719-001 | May 12, 1987 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Labs Ltd | AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 201025-003 | Apr 9, 2014 | AP | 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 |
