EXBLIFEP Drug Patent Profile
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Which patents cover Exblifep, and when can generic versions of Exblifep launch?
Exblifep is a drug marketed by Allecra Theraps and is included in one NDA. There are two patents protecting this drug.
This drug has twenty-five patent family members in eighteen countries.
The generic ingredient in EXBLIFEP is cefepime hydrochloride; enmetazobactam. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cefepime hydrochloride; enmetazobactam profile page.
DrugPatentWatch® Generic Entry Outlook for Exblifep
Exblifep will be eligible for patent challenges on February 22, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 22, 2034. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for EXBLIFEP
International Patents: | 25 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in EXBLIFEP? | EXBLIFEP excipients list |
DailyMed Link: | EXBLIFEP at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EXBLIFEP
Generic Entry Date for EXBLIFEP*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW NDA:
Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for EXBLIFEP
Drug Class | Cephalosporin Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for EXBLIFEP
US Patents and Regulatory Information for EXBLIFEP
EXBLIFEP is protected by two US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EXBLIFEP is ⤷ Try a Trial.
This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting EXBLIFEP
Crystalline beta-lactamase inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF SPECIFIED POLYMORPHS OF EXBLIFEP (CEFEPIME AND ENMETAZOBACTAM) FOR TREATING COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY DESIGNATED SUSCEPTIBLE MICROORGANISMS
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF EXBLIFEP (CEFEPIME AND ENMETAZOBACTAM) FOR TREATING COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY DESIGNATED SUSCEPTIBLE MICROORGANISMS
FDA Regulatory Exclusivity protecting EXBLIFEP
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allecra Theraps | EXBLIFEP | cefepime hydrochloride; enmetazobactam | POWDER;INTRAVENOUS | 216165-001 | Feb 22, 2024 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Allecra Theraps | EXBLIFEP | cefepime hydrochloride; enmetazobactam | POWDER;INTRAVENOUS | 216165-001 | Feb 22, 2024 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Allecra Theraps | EXBLIFEP | cefepime hydrochloride; enmetazobactam | POWDER;INTRAVENOUS | 216165-001 | Feb 22, 2024 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Allecra Theraps | EXBLIFEP | cefepime hydrochloride; enmetazobactam | POWDER;INTRAVENOUS | 216165-001 | Feb 22, 2024 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for EXBLIFEP
See the table below for patents covering EXBLIFEP around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
United Kingdom | 201408643 | ⤷ Try a Trial | |
Eurasian Patent Organization | 201690963 | КРИСТАЛЛИЧЕСКИЙ ИНГИБИТОР β-ЛАКТАМАЗЫ | ⤷ Try a Trial |
Chile | 2016001097 | Inhibidor de beta-lactamasa cristalina | ⤷ Try a Trial |
Japan | 2021102642 | 結晶性β−ラクタマーゼ阻害剤 (CRYSTALLINE β-LACTAMASE INHIBITOR) | ⤷ Try a Trial |
Mexico | 2016005869 | INHIBIDOR DE BETA-LACTAMASA CRISTALINA. (CRYSTALLINE BETA-LACTAMASE INHIBITOR.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |