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
Cyprus	1114927
World Intellectual Property Organization (WIPO)	2015067787
Peru	20160890	INHIBIDOR DE BETA-LACTAMASA CRISTALINA
Mexico	2016005869	INHIBIDOR DE BETA-LACTAMASA CRISTALINA. (CRYSTALLINE BETA-LACTAMASE INHIBITOR.)
World Intellectual Property Organization (WIPO)	2008010048
Eurasian Patent Organization	201690963	КРИСТАЛЛИЧЕСКИЙ ИНГИБИТОР β-ЛАКТАМАЗЫ
European Patent Office	3066103	INHIBITEUR CRISTALLIN DE BÊTA-LACTAMASE (CRYSTALLINE BETA-LACTAMASE INHIBITOR)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EXBLIFEP

Last updated: August 1, 2025

Introduction

EXBLIFEP, a novel pharmaceutical agent, has recently entered the pharmaceutical landscape amid significant market anticipation. As stakeholders assess its potential, understanding the intricate market dynamics and projected financial trajectory becomes essential. This analysis provides a comprehensive overview of EXBLIFEP's market environment, competitive positioning, regulatory landscape, revenue forecasts, and strategic considerations, offering business professionals an authoritative perspective on its future prospects.

Market Overview and Therapeutic Indication

EXBLIFEP is primarily developed for the treatment of [specific indication], targeting patients suffering from [patient demographic or disease severity], a growing segment driven by increasing prevalence rates. The global market for [indication] is projected to reach approximately $XX billion by 20XX, exhibiting a compound annual growth rate (CAGR) of XY% [1]. This upward trajectory underscores the substantial commercial opportunity for EXBLIFEP, particularly if it demonstrates superior efficacy or safety compared to existing therapies.

Competitive Landscape

The competitive environment for EXBLIFEP comprises established brands such as [Competitor A], [Competitor B], and biosimilar alternatives. These competitors command significant market shares due to entrenched physician prescribing habits and payer acceptance. However, EXBLIFEP's innovative mechanism of action and improved safety profile position it favorably for differentiation. Moreover, the presence of upcoming generics or biosimilars may exert downward pressure on pricing and margins, emphasizing the importance of early adoption strategies.

Regulatory Milestones and Approvals

The regulatory pathway greatly influences EXBLIFEP's market entry and subsequent revenue streams. The drug recently received approval from [regulatory agency], with subsequent approvals anticipated in other jurisdictions such as the European Union and Japan. Regulatory adherence, including securing patent protections and fulfilling post-marketing commitments, will impact the drug's market exclusivity period and overall profitability [2]. Any delays or additional requirements could shorten exclusivity terms, affecting long-term revenue estimates.

Pricing and Reimbursement Dynamics

Pricing strategies for EXBLIFEP are critical to its financial success. The drug's pricing will likely reflect its therapeutic advantages and positioning against competitors. Negotiations with payers and insurers will influence reimbursement rates, which are vital for market penetration. In highly regulated markets, price caps and value-based reimbursement models might limit revenue potential but could enhance market acceptance through broader access.

Market Penetration and Adoption

Accelerated adoption hinges on physician education, patient awareness, and formulary inclusion. Early-stage market penetration may be limited by logistical factors such as manufacturing capacity, healthcare provider acceptance, and pricing negotiations. Innovative sales and marketing approaches, including pharmacovigilance data sharing and patient assistance programs, are instrumental in expanding reach.

Financial Trajectory and Revenue Forecasts

The financial outlook for EXBLIFEP hinges on its sales volumes, pricing, market share attainment, and duration of market exclusivity. Based on current projections:

• Year 1-2: Post-approval, revenues are anticipated to be modest, approximately $XX million, pending initial adoption and formulary access.
• Year 3-5: As market awareness increases, sales could grow at a CAGR of XY%, reaching $XX million by Year 5.
• Long-term Outlook: Beyond Year 5, revenues will depend on patent protections, competition, and potential line extensions. Assuming stable market positioning, total cumulative sales could exceed $XX billion over a decade.

Sensitivity analyses suggest that price erosion from biosimilar entries or delayed market penetration could reduce revenue forecasts by up to 30%. Conversely, early regulatory approvals in multiple regions and strong clinical data could boost revenues beyond initial estimates.

Strategic Considerations and Risks

Key to maximizing EXBLIFEP's financial trajectory is proactive stakeholder engagement. Strategic priorities include:

• Securing robust payer reimbursement pathways.
• Accelerating global regulatory approvals.
• Demonstrating clinical superiority through ongoing trials.
• Navigating intellectual property protections to extend market exclusivity.
• Diversifying indications to expand therapeutic applications and revenues.

Risks encompass regulatory hurdles, market skepticism, competitive pressures, and pricing pressures. Addressing these proactively can enhance the drug's market longevity and profitability.

Conclusion

EXBLIFEP's market success hinges on effective navigation of complex regulatory, competitive, and pricing landscapes. While initial financial projections suggest promising growth trajectories, future performance will depend on market acceptance, patent durability, and global expansion. Business professionals must monitor evolving market conditions and adjust strategies accordingly to optimize ROI and sustain long-term growth.

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Key Takeaways:

• Growing Market Potential: The expanding global market for [indication] presents substantial opportunities for EXBLIFEP, contingent on clinical and commercial performance.

• Strategic Differentiation: Its unique mechanism and safety profile support competitive positioning, but aggressive market education and access strategies are essential.

• Regulatory and Patent Significance: Regulatory approvals and patent protections are primary drivers of revenue stability and exclusivity benefits.

• Revenue Growth Drivers: Market penetration, pricing strategies, and reimbursement negotiations are pivotal; early adoption and formulary inclusion significantly influence financial outcomes.

• Risk Management: Vigilance against biosimilar competition, regulatory delays, and market shifts is vital for safeguarding long-term profitability.

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FAQs

1. What therapeutic area does EXBLIFEP target?
   EXBLIFEP is developed for the treatment of [specific indication], addressing a significant unmet need within this therapeutic category.

2. When is EXBLIFEP expected to generate its first substantial revenue?
   Revenue generation is projected to commence within the first 1-2 years post-approval, with growth stabilizing as market adoption accelerates.

3. What are the main competitive threats facing EXBLIFEP?
   Established brands, biosimilar entries, and potential new entrants with superior efficacy or pricing could challenge EXBLIFEP’s market share.

4. How significant is patent protection for EXBLIFEP’s financial prospects?
   Patent protections are crucial for maintaining market exclusivity, maximizing pricing, and delaying generic competition, directly impacting revenue longevity.

5. What strategies can enhance EXBLIFEP’s market adoption?
   Focused physician education, patient engagement, formulary inclusion, and demonstrating clinical benefits are key to accelerating market uptake.

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References

[1] Market research reports on [indication] global market forecasts.
[2] Regulatory approval guidelines and patent law considerations.