Ertapenem sodium - Generic Drug Details
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What are the generic sources for ertapenem sodium and what is the scope of patent protection?
Ertapenem sodium
is the generic ingredient in two branded drugs marketed by Acs Dobfar Spa, Eugia Pharma, Gland Pharma Ltd, Savior Lifetec Corp, Sun Pharm, and Msd Sub Merck, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for ertapenem sodium. Fourteen suppliers are listed for this compound.
Summary for ertapenem sodium
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 6 |
NDAs: | 6 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 88 |
Clinical Trials: | 12 |
Patent Applications: | 647 |
What excipients (inactive ingredients) are in ertapenem sodium? | ertapenem sodium excipients list |
DailyMed Link: | ertapenem sodium at DailyMed |
Recent Clinical Trials for ertapenem sodium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
M.D. Anderson Cancer Center | Phase 2 |
Albany College of Pharmacy and Health Sciences | Phase 4 |
Merck Sharp & Dohme Corp. | Phase 4 |
Pharmacology for ertapenem sodium
Drug Class | Penem Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for ertapenem sodium
Paragraph IV (Patent) Challenges for ERTAPENEM SODIUM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
INVANZ | Injection | ertapenem sodium | 1 g/vial | 021337 | 1 | 2012-12-21 |
US Patents and Regulatory Information for ertapenem sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Savior Lifetec Corp | ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 207647-001 | Mar 19, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Msd Sub Merck | INVANZ | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 021337-001 | Nov 21, 2001 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Eugia Pharma | ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 209133-001 | Jun 25, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Gland Pharma Ltd | ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 212040-001 | Mar 26, 2021 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Acs Dobfar Spa | ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 208790-001 | Apr 16, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sun Pharm | ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 209145-001 | May 2, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ertapenem sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Msd Sub Merck | INVANZ | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 021337-001 | Nov 21, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | INVANZ | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 021337-001 | Nov 21, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | INVANZ | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 021337-001 | Nov 21, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | INVANZ | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 021337-001 | Nov 21, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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