BAFIERTAM Drug Patent Profile

When do Bafiertam patents expire, and when can generic versions of Bafiertam launch?

Bafiertam is a drug marketed by Banner Life Sciences and is included in one NDA. There are twenty-one patents protecting this drug.

This drug has twenty patent family members in seven countries.

The generic ingredient in BAFIERTAM is monomethyl fumarate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the monomethyl fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Bafiertam

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 27, 2035. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BAFIERTAM

International Patents:	20
US Patents:	21
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	3
Patent Applications:	3,521
Drug Prices:	Drug price information for BAFIERTAM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BAFIERTAM
What excipients (inactive ingredients) are in BAFIERTAM?	BAFIERTAM excipients list
DailyMed Link:	BAFIERTAM at DailyMed

See drug prices for BAFIERTAM

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

NDA:

210296

Dosage:

CAPSULE, DELAYED RELEASE;ORAL

^*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.

Recent Clinical Trials for BAFIERTAM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Banner Life Sciences LLC	Phase 1

See all BAFIERTAM clinical trials

US Patents and Regulatory Information for BAFIERTAM

BAFIERTAM is protected by twenty-one US patents.

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
Banner Life Sciences	BAFIERTAM	monomethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210296-001	Apr 28, 2020		RX	Yes	Yes
Banner Life Sciences	BAFIERTAM	monomethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210296-001	Apr 28, 2020		RX	Yes	Yes			Y
Banner Life Sciences	BAFIERTAM	monomethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210296-001	Apr 28, 2020		RX	Yes	Yes

International Patents for BAFIERTAM

When does loss-of-exclusivity occur for BAFIERTAM?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Denmark

European Patent Office

Israel

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BAFIERTAM around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016057133
European Patent Office	3766487
World Intellectual Property Organization (WIPO)	2015130998

Market Dynamics and Financial Trajectory for Bafiertam (Lumasiran)

Last updated: July 27, 2025

Introduction

Bafiertam, known generically as lumasiran, represents a novel therapeutic agent primarily developed to target specific genetic disorders, notably primary hyperoxaluria type 1 (PH1). As a groundbreaking RNA interference (RNAi) therapy, Bafiertam aims to mitigate disease progression by silencing key genes responsible for oxalate overproduction. Understanding its market dynamics and financial trajectory involves analyzing its clinical development, competitive landscape, regulatory environment, and market adoption potential.

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Strategic Development and Clinical Progress

Lumasiran was developed by Alnylam Pharmaceuticals, a pioneer in RNAi therapeutics. The drug received FDA approval in December 2020 for the treatment of PH1, a rare, devastating metabolic disorder characterized by excess oxalate production, leading to kidney stones and renal failure (FDA, 2020). The approval was based on pivotal Phase 3 trials demonstrating significant reduction in urinary oxalate levels, a surrogate for disease activity.

The successful clinical outcomes not only cement Bafiertam’s position as a first-in-class therapy but also open avenues for expanding indications, potentially encompassing broader oxalate-related disorders.

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Market Dynamics

1. Market Size and Unmet Need

Primary hyperoxaluria type 1 is a rare disease affecting approximately 1 in 120,000 to 1 in 250,000 individuals globally (National Organization for Rare Disorders, 2022). The scarcity is offset by the severity and limited treatment options for PH1, presenting a sizable unmet need.

The total addressable market (TAM) is constrained by disease rarity but commands premium pricing due to the high burden of untreated disease. Estimates suggest that the global market for PH1 treatments could reach $1 billion within the next five years, driven by increased diagnosis rates and physician awareness (EvaluatePharma, 2021).

2. Competitive Landscape

Alnylam’s Bafiertam is a forerunner in RNAi therapy; however, competition is materializing:

• Lumasiran’s Pipeline: Alnylam continuously enhances its pipeline, with investigational extensions into other oxalate-related diseases and potential combination therapies.
• Emerging Therapies: Other biotech firms are developing gene editing and antisense therapies, which could challenge lumasiran’s dominance.
• Supportive Care and Off-Label Use: Existing treatments involve supportive management, such as hydration and dialysis, which, although less effective, are widely accessible and inexpensive. These form barriers to rapid market penetration, especially in emerging markets.

3. Market Adoption Factors

Factors influencing early and sustained adoption include:

• Pricing and Reimbursement: Bafiertam is priced at a premium (~$450,000 annually per patient). Reimbursement decisions by payers will significantly influence its market penetration.
• Physician and Patient Awareness: Education campaigns improve early diagnosis and treatment initiation.
• Access in Global Markets: Regulatory approvals outside the US and EU are crucial for revenue expansion. So far, Bafiertam has secured EMA approval, with ongoing submissions in other markets.

4. Regulatory Environment

Regulatory agencies, especially FDA and EMA, have provided robust support for RNAi therapies. The FDA’s Fast Track and Breakthrough Therapy designations accelerated Bafiertam’s review process, enabling earlier market access. Future approvals for broader indications could further fortify its market potential.

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Financial Trajectory

1. Revenue Generation

As of fiscal year 2022, Alnylam reported revenue from lumasiran exceeding $25 million, primarily from initial geographic markets (Alnylam Financials, 2022). The revenue trajectory is expected to accelerate with increased adoption and expanded indications.

2. Pricing Strategy and Reimbursement

Premium pricing incentivizes high-margin revenues but depends on securing reimbursement from payers. Alnylam’s engagement with healthcare authorities encompasses value demonstration through health economics and outcomes research (HEOR), which supports favorable coverage decisions.

3. Market Penetration and Growth

Assuming steady regulatory approvals worldwide, Bafiertam’s sales could grow at a CAGR of 20-30% over the next five years, reaching $200-$300 million by 2027. The trajectory hinges on:

• Market Access: Easier access in established markets (~70% of the global opportunity).
• Patient Initiation: Improved diagnosis rates through disease awareness programs.
• Additional Indications: Expansion into related metabolic disorders.

4. R&D and Investment Outlook

Continued R&D investments aim to extend Bafiertam’s therapeutic utility and develop next-gen RNAi platforms. These expenditures, while affecting short-term profitability, lay groundwork for future revenue streams, potentially including combination therapies or proactive disease management tools.

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Market Challenges and Opportunities

Challenges:

• Pricing Pressures: Healthcare systems are increasingly scrutinizing high-cost therapies.
• Market Penetration Barriers: Limited awareness and diagnostic delays impinge upon treatment uptake.
• Competitive Innovation: The emergence of gene editing (e.g., CRISPR) approaches could disrupt the RNAi paradigm.

Opportunities:

• Expanding Indications: Broader use in oxalate disorders increases revenue potential.
• Global Market Access: Greater penetration in emerging markets could diversify revenue streams.
• Partnerships and Collaborations: Strategic alliances may optimize distribution and accelerate adoption.

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Key Takeaways

• Market Dynamics: Bafiertam’s position as a first-in-class RNAi agent for PH1 affords a significant, albeit niche, market with high treatment costs, driven by unmet clinical needs and disease severity.
• Financial Trajectory: Revenue growth forecasts are optimistic, contingent on regulatory approvals, payer acceptance, and expanded indications. Premium pricing and strategic payer negotiations will dictate profitability.
• Strategic Focus Areas: Enhancing diagnosis, increasing global access, and demonstrating value through robust health economics will catalyze market penetration.
• Competitive Landscape: Innovators in genetic medicine pose potential challenges, emphasizing the need for continuous R&D and strategic positioning.
• Long-Term Outlook: With a sustained focus on growth avenues, including broader applications and geographic expansion, Bafiertam’s financial trajectory looks promising, potentially transforming the treatment landscape for rare oxalate disorders.

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FAQs

Q1: How does Bafiertam compare to existing treatments for primary hyperoxaluria type 1?
A1: Bafiertam (lumasiran) offers targeted gene silencing via RNA interference, reducing urinary oxalate levels significantly, outperforming supportive therapies like hydration and dialysis, which are less effective in controlling disease progression.

Q2: What are the main barriers to Bafiertam’s market penetration?
A2: High treatment costs, limited disease awareness, diagnostic delays, and regulatory hurdles in emerging markets pose key barriers to widespread adoption.

Q3: What is the potential for expanding Bafiertam’s indications?
A3: Given its mechanism, Bafiertam may be studied for other oxalate-related conditions, such as secondary hyperoxaluria, though regulatory approvals are currently limited to PH1.

Q4: How do reimbursement policies impact Bafiertam’s financial outlook?
A4: Favorable reimbursement enhances market access and revenue growth; conversely, reimbursement challenges due to high costs could hinder adoption, emphasizing the importance of compelling value demonstrations.

Q5: Which strategic initiatives could boost Bafiertam’s long-term success?
A5: Expanding global regulatory approval, developing combination therapies, increasing awareness and diagnosis rates, and entering new markets are critical strategies.

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References

[1] FDA. (2020). FDA approves first RNA interference drug to treat a rare genetic disease.

[2] National Organization for Rare Disorders. (2022). Primary hyperoxaluria.

[3] EvaluatePharma. (2021). The global market for rare disease therapies.

[4] Alnylam Pharmaceuticals. (2022). Annual Financial Report.