Meropenem - Generic Drug Details
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What are the generic sources for meropenem and what is the scope of freedom to operate?
Meropenem
is the generic ingredient in four branded drugs marketed by Acs Dobfar, Acs Dobfar Spa, Amneal Pharms, Brooks Steriscience, Daewoong Pharm Co, Eugia Pharma, Gland, Hospira Inc, Hq Spclt Pharma, Sandoz, Savior Lifetec Corp, Pfizer, B Braun Medical Inc, and Rempex, and is included in fifteen NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are thirty-two drug master file entries for meropenem. Thirteen suppliers are listed for this compound.
Summary for meropenem
US Patents: | 7 |
Tradenames: | 4 |
Applicants: | 14 |
NDAs: | 15 |
Drug Master File Entries: | 32 |
Finished Product Suppliers / Packagers: | 13 |
Raw Ingredient (Bulk) Api Vendors: | 84 |
Clinical Trials: | 137 |
Patent Applications: | 6,510 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for meropenem |
What excipients (inactive ingredients) are in meropenem? | meropenem excipients list |
DailyMed Link: | meropenem at DailyMed |
Recent Clinical Trials for meropenem
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Scandinavian Critical Care Trials Group | Phase 4 |
Rutgers Robert Wood Johnson Medical School | Phase 4 |
Assaf-Harofeh Medical Center | Phase 4 |
Pharmacology for meropenem
Drug Class | Penem Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for meropenem
US Patents and Regulatory Information for meropenem
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rempex | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Savior Lifetec Corp | MEROPENEM | meropenem | INJECTABLE;INJECTION | 206086-001 | Apr 19, 2016 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
B Braun Medical Inc | MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | meropenem | POWDER;INTRAVENOUS | 202106-001 | Apr 30, 2015 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Rempex | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hospira Inc | MEROPENEM | meropenem | INJECTABLE;INJECTION | 090940-002 | Jun 22, 2010 | 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 meropenem
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | MERREM | meropenem | INJECTABLE;INJECTION | 050706-001 | Jun 21, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | MERREM | meropenem | INJECTABLE;INJECTION | 050706-003 | Jun 21, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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