IMIPENEM AND CILASTATIN Drug Patent Profile
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Which patents cover Imipenem And Cilastatin, and when can generic versions of Imipenem And Cilastatin launch?
Imipenem And Cilastatin is a drug marketed by Acs Dobfar, Hospira Inc, and Hq Spclt Pharma. and is included in four NDAs.
The generic ingredient in IMIPENEM AND CILASTATIN is cilastatin sodium; imipenem. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cilastatin sodium; imipenem profile page.
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Summary for IMIPENEM AND CILASTATIN
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 12 |
| Clinical Trials: | 44 |
| Patent Applications: | 156 |
| DailyMed Link: | IMIPENEM AND CILASTATIN at DailyMed |
Recent Clinical Trials for IMIPENEM AND CILASTATIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Spero Therapeutics | Phase 3 |
| GlaxoSmithKline | Phase 3 |
| Meiji Seika Pharma Co., Ltd. | Phase 3 |
Pharmacology for IMIPENEM AND CILASTATIN
| Drug Class | Penem Antibacterial Renal Dehydropeptidase Inhibitor |
| Mechanism of Action | Dipeptidase Inhibitors |
US Patents and Regulatory Information for IMIPENEM AND CILASTATIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acs Dobfar | IMIPENEM AND CILASTATIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 090577-001 | Dec 21, 2011 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira Inc | IMIPENEM AND CILASTATIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 090825-002 | Nov 16, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acs Dobfar | IMIPENEM AND CILASTATIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 090577-002 | Dec 21, 2011 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira Inc | IMIPENEM AND CILASTATIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 090825-001 | Nov 16, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hq Spclt Pharma | IMIPENEM AND CILASTATIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 207594-001 | Dec 12, 2019 | AP | RX | 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 |
