PRIMAXIN Drug Patent Profile
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Which patents cover Primaxin, and when can generic versions of Primaxin launch?
Primaxin is a drug marketed by Merck and is included in three NDAs.
The generic ingredient in PRIMAXIN 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 PRIMAXIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 59 |
| Clinical Trials: | 2 |
| Drug Prices: | Drug price information for PRIMAXIN |
| What excipients (inactive ingredients) are in PRIMAXIN? | PRIMAXIN excipients list |
| DailyMed Link: | PRIMAXIN at DailyMed |
Recent Clinical Trials for PRIMAXIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Sharp & Dohme Corp. | Phase 1 |
| Pfizer | Phase 3 |
| AstraZeneca | Phase 3 |
Pharmacology for PRIMAXIN
| Drug Class | Penem Antibacterial Renal Dehydropeptidase Inhibitor |
| Mechanism of Action | Dipeptidase Inhibitors |
US Patents and Regulatory Information for PRIMAXIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merck | PRIMAXIN | cilastatin sodium; imipenem | INJECTABLE;INJECTION | 062756-001 | Jan 8, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck | PRIMAXIN | cilastatin sodium; imipenem | POWDER;INTRAMUSCULAR | 050630-002 | Dec 14, 1990 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck | PRIMAXIN | cilastatin sodium; imipenem | INJECTABLE;INJECTION | 062756-002 | Jan 8, 1987 | DISCN | No | No | ⤷ 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 | ||||
| Merck | PRIMAXIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 050587-002 | Nov 26, 1985 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Merck | PRIMAXIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 050587-001 | Nov 26, 1985 | DISCN | Yes | 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 PRIMAXIN
| 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 |
International Patents for PRIMAXIN
See the table below for patents covering PRIMAXIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Croatia | P940099 | PROCESS FOR THE PREPARATION OF Z-2-ACYLAMINO-3-MONOSUBSTITUTED PROPENIC ACIDS AND THEIR ESTERS AND SALTS | ⤷ Sign Up |
| Poland | 125506 | ⤷ Sign Up | |
| Denmark | 157399 | ⤷ Sign Up | |
| German Democratic Republic | 145059 | VERFAHREN ZUR HERSTELLUNG EINER ANTIBAKTERIELLEN ZUSAMMENSETZUNG | ⤷ Sign Up |
| New Zealand | 190994 | Z-2-ACYLAMINO-3-MONOSUBSTITUTED PROPENOATES | ⤷ Sign Up |
| Finland | 792282 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PRIMAXIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2666774 | PA2020518,C2666774-2 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RELEBAKTAMAS, PASIRINKTINAI MONOHIDRATO PAVIDALU, SU IMIPENEMU IR CILASTATINU, PASIRINKTINAI NATRIO DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1420 20200213 |
| 2666774 | 122020000036 | Germany | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM, ODER RELEBACTAM IN FORM DES MONOHYDRATES, IMIPENEM UND CILASTATIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1420 20200213 |
| 2666774 | 20C1032 | France | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM OPTIONNELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE OPTIONNELLEMENT SOUS FORME DE SEL SODIQUE; REGISTRATION NO/DATE: EU/1/19/1420 20200217 |
| 2666774 | CA 2020 00037 | Denmark | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217 |
| 2666774 | 2020024 | Norway | ⤷ Sign Up | PRODUCT NAME: KOMBINASJON AV RELEBAKTAM EVENTUELT I FORM AV MONOHYDRAT, IMIPENEM OG CILASTATIN, EVENTUELT I FORM AV NATRIUMSALT; REG. NO/DATE: EU/1/19/1420 20200219 |
| 2666774 | 31/2020 | Austria | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM, GEGEBENENFALLS IN DER FORM DES MONOHYDRATS, IMIPENEM UND CILASTATIN, GEGEBENENFALLS IN DER FORM DES NATRIUMSALZES.; REGISTRATION NO/DATE: EU/1/19/1420 (MITTEILUNG) 20200217 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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