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

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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

Drug patent expirations by year for EXBLIFEP

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EXBLIFEP

Generic Entry Date for EXBLIFEP^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: GENERATING ANTIBIOTIC INCENTIVES NOW NDA: 216165 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

J01DE	Fourth-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Allecra Theraps	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Allecra Theraps	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Allecra Theraps	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		RX	Yes	Yes	⤷ 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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Country	Patent Number	Title	Estimated Expiration
United Kingdom	201408643		⤷ Sign Up
Eurasian Patent Organization	201690963	КРИСТАЛЛИЧЕСКИЙ ИНГИБИТОР β-ЛАКТАМАЗЫ	⤷ Sign Up
Chile	2016001097	Inhibidor de beta-lactamasa cristalina	⤷ Sign Up
Japan	2021102642	結晶性β−ラクタマーゼ阻害剤 (CRYSTALLINE β-LACTAMASE INHIBITOR)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration