Ertapenem sodium - Generic Drug Details
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What are the generic drug 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: | 654 |
| Formulation / Manufacturing: | see details |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eugia Pharma | ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 209133-001 | Jun 25, 2018 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Savior Lifetec Corp | ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 207647-001 | Mar 19, 2019 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm | ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 209145-001 | May 2, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Acs Dobfar Spa | ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 208790-001 | Apr 16, 2018 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Msd Sub Merck | INVANZ | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 021337-001 | Nov 21, 2001 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | INVANZ | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 021337-001 | Nov 21, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | INVANZ | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 021337-001 | Nov 21, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | INVANZ | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 021337-001 | Nov 21, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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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