ERTAPENEM SODIUM Drug Patent Profile
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Which patents cover Ertapenem Sodium, and when can generic versions of Ertapenem Sodium launch?
Ertapenem Sodium is a drug marketed by Acs Dobfar Spa, Eugia Pharma, Gland Pharma Ltd, Savior Lifetec Corp, and Sun Pharm. and is included in five NDAs.
The generic ingredient in ERTAPENEM SODIUM is ertapenem sodium. There are eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ertapenem sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ertapenem Sodium
A generic version of ERTAPENEM SODIUM was approved as ertapenem sodium by ACS DOBFAR SPA on April 16th, 2018.
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Summary for ERTAPENEM SODIUM
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 12 |
| Patent Applications: | 430 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| 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 | |||
| 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 | |||
| 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 |
