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Ertapenem sodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ertapenem sodium?

Ertapenem sodium is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty patent family members in forty countries.

There are seven drug master file entries for ertapenem sodium. One supplier is listed for this compound.

Summary for Generic Name: ertapenem sodium

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list7
Suppliers / Packagers: see list1
Bulk Api Vendors: see list63
Clinical Trials: see list930
Patent Applications: see list1,752
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ertapenem sodium at DailyMed

Pharmacology for Ingredient: ertapenem sodium

Ingredient-typeCarbapenems
Drug ClassPenem Antibacterial
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
INVANZ
ertapenem sodium
INJECTABLE;INTRAMUSCULAR, IV (INFUSION)021337-001Nov 21, 2001RXYesYes5,952,323*PED► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ertapenem sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
INVANZ
ertapenem sodium
INJECTABLE;INTRAMUSCULAR, IV (INFUSION)021337-001Nov 21, 20015,478,820*PED► Subscribe
Merck Sharp Dohme
INVANZ
ertapenem sodium
INJECTABLE;INTRAMUSCULAR, IV (INFUSION)021337-001Nov 21, 20015,652,233*PED► Subscribe
Merck Sharp Dohme
INVANZ
ertapenem sodium
INJECTABLE;INTRAMUSCULAR, IV (INFUSION)021337-001Nov 21, 20017,342,005*PED► Subscribe
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International Patent Family for Ingredient: ertapenem sodium

Country Document Number Estimated Expiration
Estonia04678► Subscribe
Yugoslavia4198► Subscribe
Poland324746► Subscribe
JapanH11509871► Subscribe
Indonesia16974► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ERTAPENEM SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0579826/01Switzerland► SubscribePRODUCT NAME: ERTAPENEM; REGISTRATION NUMBER/DATE: SWISSMEDIC 55902 02.12.2005
2004008,C0863901Lithuania► SubscribePRODUCT NAME: ERTAPENEMUM ((4R,5S,6S)-3-((3S,5S)-5-((3-KARBOKSIFENIL)AMINO)KARBONIL)-3-PIROLIDINIL)TIO)-6-((1R)-1HIDROKSIETIL)-4-METIL-7-OKSO-1-AZABICIKLO-(3.2.0)HEPT-2-EN-2-KARBOKSIRUGSTIS; REGISTRATION NO/DATE: 03/8043/3 20030328
0863901/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
2004008Lithuania► SubscribePRODUCT NAME: ERTAPENEMUM ([4R,5S,6S]-3-[(3S,5S)-5-[(3-KARBOKSIFENIL) AMINO]KARBONIL]-3-PIROLIDINIL]TIO]-6-[(1R)-1HIDROKSIETIL]-4-METIL-7-OKSO-1-AZABICIKLO-[3.2.0]HEPT-2-EN-2-KARBOKSIRUGSTIS; REGISTRATION NO/DATE: 03/8043/3 20030328
C/GB02/042United Kingdom► SubscribePRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020418
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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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