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. 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
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Summary for EXBLIFEP
| International Patents: | 25 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| What excipients (inactive ingredients) are in EXBLIFEP? | EXBLIFEP excipients list |
| DailyMed Link: | EXBLIFEP at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EXBLIFEP
*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.
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 ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up
| 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 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Allecra Theraps | EXBLIFEP | cefepime hydrochloride; enmetazobactam | POWDER;INTRAVENOUS | 216165-001 | Feb 22, 2024 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Allecra Theraps | EXBLIFEP | cefepime hydrochloride; enmetazobactam | POWDER;INTRAVENOUS | 216165-001 | Feb 22, 2024 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Allecra Theraps | EXBLIFEP | cefepime hydrochloride; enmetazobactam | POWDER;INTRAVENOUS | 216165-001 | Feb 22, 2024 | 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 |
International Patents for EXBLIFEP
See the table below for patents covering EXBLIFEP around the world.
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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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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