CILASTATIN SODIUM; IMIPENEM - Generic Drug Details
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What are the generic sources for cilastatin sodium; imipenem and what is the scope of patent protection?
Cilastatin sodium; imipenem
is the generic ingredient in three branded drugs marketed by Merck, Acs Dobfar, Hospira Inc, Hq Spclt Pharma, and Msd Merck Co, and is included in eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Three suppliers are listed for this compound.
Summary for CILASTATIN SODIUM; IMIPENEM
| US Patents: | 1 |
| Tradenames: | 3 |
| Applicants: | 5 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 3 |
| Clinical Trials: | 2 |
| DailyMed Link: | CILASTATIN SODIUM; IMIPENEM at DailyMed |
Recent Clinical Trials for CILASTATIN SODIUM; IMIPENEM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Phase 2 |
| Merck Sharp & Dohme Corp. | Phase 3 |
Pharmacology for CILASTATIN SODIUM; IMIPENEM
| Drug Class | Penem Antibacterial Renal Dehydropeptidase Inhibitor |
| Mechanism of Action | Dipeptidase Inhibitors |
US Patents and Regulatory Information for CILASTATIN SODIUM; IMIPENEM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospira Inc | IMIPENEM AND CILASTATIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 090825-001 | Nov 16, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msd Merck Co | RECARBRIO | cilastatin sodium; imipenem; relebactam | POWDER;INTRAVENOUS | 212819-001 | Jul 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck | PRIMAXIN | cilastatin sodium; imipenem | POWDER;INTRAMUSCULAR | 050630-001 | Dec 14, 1990 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira Inc | IMIPENEM AND CILASTATIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 091007-001 | Nov 16, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acs Dobfar | IMIPENEM AND CILASTATIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 090577-001 | Dec 21, 2011 | RX | No | Yes | ⤷ 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 | |||
| Hospira Inc | IMIPENEM AND CILASTATIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 090825-002 | Nov 16, 2011 | 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 CILASTATIN SODIUM; IMIPENEM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck | PRIMAXIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 050587-002 | Nov 26, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| Merck | PRIMAXIN | cilastatin sodium; imipenem | POWDER;INTRAMUSCULAR | 050630-001 | Dec 14, 1990 | ⤷ Sign Up | ⤷ Sign Up |
| Merck | PRIMAXIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 050587-001 | Nov 26, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| Merck | PRIMAXIN | cilastatin sodium; imipenem | POWDER;INTRAMUSCULAR | 050630-002 | Dec 14, 1990 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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 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.
ISSN: 2162-2639
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