EXBLIFEP Drug Patent Profile

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

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

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.

US Patents and Regulatory Information for EXBLIFEP

EXBLIFEP is protected by two US patents and two FDA Regulatory Exclusivities.

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.

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			Y	Y
Allecra Theraps	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		DISCN	Yes	No
Allecra Theraps	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		DISCN	Yes	No
Allecra Theraps	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		DISCN	Yes	No

International Patents for EXBLIFEP

See the table below for patents covering EXBLIFEP around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	7045795
Japan	2021102642	結晶性β−ラクタマーゼ阻害剤 (CRYSTALLINE β-LACTAMASE INHIBITOR)
Cyprus	1114927
Japan	2016535054	結晶性β−ラクタマーゼ阻害剤
Spain	2427122

EXBLIFEP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EXBLIFEP

Introduction to EXBLIFEP

EXBLIFEP, a novel antibiotic combination of cefepime and enmetazobactam, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis, in patients 18 years and older. This approval marks a significant milestone in the fight against antimicrobial resistance (AMR), particularly against extended-spectrum β-lactamase (ESBL)-producing bacteria[4].

Market Need and Unmet Medical Needs

The current standard of care for cUTIs, piperacillin/tazobactam, is increasingly threatened by the growing prevalence of ESBL-mediated resistance. ESBL-producing pathogens are often resistant to most fluoroquinolone, aminoglycoside, and β-lactam antibiotics, necessitating the use of carbapenem antibiotics as a last resort. However, the increased use of carbapenems has led to the emergence of carbapenem-resistant Enterobacterales (CRE), highlighting the critical need for "carbapenem-sparing" options like EXBLIFEP[1].

Clinical Efficacy and Superiority

EXBLIFEP has demonstrated statistically significant superior overall treatment success compared to piperacillin/tazobactam in clinical trials. The Phase III ALLIUM trial showed that EXBLIFEP achieved a higher clinical cure and microbiological eradication rate in patients with cUTIs, including those caused by ESBL-producing pathogens (79.1% vs. 58.9% and 73.7% vs. 51.5%, respectively)[3].

Regulatory Approvals and Market Expansion

In addition to the FDA approval, EXBLIFEP has been submitted for marketing approval in the European Union and received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in January 2024. The European Medicines Agency (EMA) is expected to make a final decision soon. EXBLIFEP has also been licensed for commercialization in various regions, including the European Union, the UK, Switzerland, Norway, Greater China, and the Gulf Cooperation Council (GCC) countries, as well as South Africa[1][4].

Licensing and Partnerships

Allecra Therapeutics has entered into several exclusive licensing agreements to facilitate the global commercialization of EXBLIFEP. These agreements include partnerships with Advanz Pharma for the European Union, Shanghai Haini Pharmaceutical for Greater China, and Acino for the GCC countries and South Africa. These partnerships are crucial for the widespread availability and marketing of the drug[3][4].

Financial Projections and Revenue Streams

Orchid Pharma, the original developer of enmetazobactam, is expected to receive a royalty of 6-8% on global sales of EXBLIFEP. Estimated annual global sales are projected to be between $200 million and $300 million, translating to a royalty income of $16 million to $25 million per year for Orchid Pharma. With approvals in major territories, including the EU and the US, these financial projections are likely to be realized in the coming years[2].

Market Exclusivity and Incentives

The FDA's approval of EXBLIFEP includes a five-year marketing exclusivity extension under the Generating Antibiotic Incentives Now Act (GAIN Act), which extends Allecra's market exclusivity until 2032. This exclusivity period is a significant incentive for the development of new anti-infective therapeutics, providing a protected market for EXBLIFEP to generate substantial revenue without immediate competition[4].

Challenges in the Antibiotic Market

Despite the promising outlook for EXBLIFEP, the antibiotic market faces several challenges. Financial and regulatory hurdles make it difficult to develop and commercialize new antibiotics. The concept of the "valley of death" in biotech, where companies struggle to raise funds between discovery and commercialization, is particularly relevant in the antibiotic sector. This can lead to financial instability and even bankruptcy for companies involved in antibiotic development[5].

Future Growth and Expansion

The initial growth post-launch of EXBLIFEP is expected to be strong, driven by its superior efficacy and the critical need for effective treatments against ESBL-producing bacteria. Orchid Pharma anticipates a 20% compound annual growth rate (CAGR) for the next couple of years, with significant contributions from the sales of EXBLIFEP. The company is also exploring partnerships for other products and expanding its manufacturing capacities to support growing demand[2].

Regional Market Potential

In addition to the global market, EXBLIFEP has significant potential in regional markets. For instance, in India, where the drug is expected to receive approval soon, Orchid Pharma estimates sales of around ₹200 crore, capturing a 4% share of the total anti-microbial injectable market[2].

Conclusion

EXBLIFEP represents a crucial advancement in the treatment of cUTIs and other infections caused by ESBL-producing bacteria. With its superior clinical efficacy, regulatory approvals, and strategic partnerships, the drug is poised for significant market impact. Despite the challenges inherent in the antibiotic market, the financial trajectory for EXBLIFEP looks promising, with substantial revenue projections and a protected market exclusivity period.

Key Takeaways

• Clinical Efficacy: EXBLIFEP has demonstrated superior treatment success compared to the current standard of care.
• Regulatory Approvals: Approved by the FDA and pending final approval in the EU.
• Licensing and Partnerships: Exclusive agreements for global commercialization.
• Financial Projections: Estimated annual global sales of $200-300 million.
• Market Exclusivity: Five-year marketing exclusivity extension under the GAIN Act.
• Regional Potential: Significant market potential in regions like India.

FAQs

Q1: What is EXBLIFEP and what is it used for? EXBLIFEP is a novel antibiotic combination of cefepime and enmetazobactam, approved for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis, in patients 18 years and older.

Q2: What are the key clinical benefits of EXBLIFEP? EXBLIFEP has shown statistically significant superior overall treatment success compared to piperacillin/tazobactam, particularly in treating infections caused by ESBL-producing pathogens.

Q3: Who are the key partners involved in the commercialization of EXBLIFEP? Allecra Therapeutics has partnered with Advanz Pharma for the European Union, Shanghai Haini Pharmaceutical for Greater China, and Acino for the GCC countries and South Africa.

Q4: What are the financial projections for EXBLIFEP? Estimated annual global sales are projected to be between $200 million and $300 million, with Orchid Pharma receiving a royalty of 6-8% on these sales.

Q5: What regulatory incentives support the commercialization of EXBLIFEP? The FDA's approval includes a five-year marketing exclusivity extension under the Generating Antibiotic Incentives Now Act (GAIN Act), extending Allecra's market exclusivity until 2032.

Sources

1. Express Pharma: Allecra's EXBLIFEP approval to treat cUTIs provides valuable new weapon to tackle ESBL mediated AMR: GlobalData.
2. ValuePickr Forum: Orchid Pharma Ltd - Untested.
3. Biospace: Allecra Therapeutics and Acino Sign Exclusive Licensing and Supply Agreement for Allecra's Novel Antibiotic EXBLIFEP in Gulf Cooperation Council Countries and South Africa.
4. Biospace: Allecra Therapeutics Announces U.S. FDA Approval for EXBLIFEP for the Treatment of Complicated Urinary Tract Infections.
5. C&EN: New antibiotics are hard to come by. Red tape is making the problem worse.