TREANDA Drug Patent Profile

Which patents cover Treanda, and when can generic versions of Treanda launch?

Treanda is a drug marketed by Cephalon and is included in one NDA. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-six patent family members in twenty-one countries.

The generic ingredient in TREANDA is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Treanda

A generic version of TREANDA was approved as bendamustine hydrochloride by ACCORD HLTHCARE on December 7^th, 2022.

Summary for TREANDA

International Patents:	66
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	107
Drug Prices:	Drug price information for TREANDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TREANDA
What excipients (inactive ingredients) are in TREANDA?	TREANDA excipients list
DailyMed Link:	TREANDA at DailyMed

See drug prices for TREANDA

Recent Clinical Trials for TREANDA

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

Sponsor	Phase
Regeneron Pharmaceuticals	Phase 3
Vaishalee Kenkre	Phase 1/Phase 2
University of Wisconsin, Madison	Phase 1/Phase 2

See all TREANDA clinical trials

Pharmacology for TREANDA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Paragraph IV (Patent) Challenges for TREANDA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TREANDA	Injection	bendamustine hydrochloride	90 mg/mL, 0.5 mL and 2 mL in single- dose vials	022249	1	2014-06-19
TREANDA	Injection	bendamustine hydrochloride	25 mg/vial and 100 mg/vial	022249	10	2013-06-04

US Patents and Regulatory Information for TREANDA

TREANDA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;INTRAVENOUS	022249-002	May 1, 2009	AP	RX	Yes	Yes					Y
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	022249-003	Sep 13, 2013		DISCN	Yes	No					Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;INTRAVENOUS	022249-002	May 1, 2009	AP	RX	Yes	Yes					Y

International Patents for TREANDA

When does loss-of-exclusivity occur for TREANDA?

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

Australia

Canada

China

European Patent Office

Hong Kong

Japan

Mexico

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 TREANDA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5726833
European Patent Office	2326306
Japan	5688195

Market Dynamics and Financial Trajectory for TREANDA (Bendamustine Hydrochloride)

Last updated: December 18, 2025

Summary

TREANDA (bendamustine hydrochloride) is an established chemotherapeutic agent primarily indicated for certain hematologic malignancies. Since its FDA approval in 2013, TREANDA's market dynamics have been shaped by factors including clinical efficacy, competing therapies, regulatory developments, and emerging treatment paradigms. Its financial trajectory reflects evolving adoption rates, regulatory approvals, patent landscape, and commercialization strategies. This report provides an in-depth analysis of TREANDA's market environment, sales trends, competitive positioning, and future outlook, offering healthcare stakeholders insight into its current standing and growth potential.

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What is TREANDA and How Does it Function in Oncology?

TREANDA (bendamustine hydrochloride) is an alkylating agent with a unique mechanism combining properties of both nitrogen mustards and purine analogs. It induces DNA cross-linking, leading to apoptosis in malignant cells. Approved initially for chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL), it has demonstrated efficacy particularly in relapsed/refractory settings.

Key Indications:

Indication	FDA Approval Date	Line of Therapy	Estimated Patient Population (US, 2022)
CLL (First-line and Relapsed)	2013	2nd/3rd line	~20,000 (US)
Indolent NHL (Including Follicular Lymphoma)	2014 (expanded)	Relapsed/refractory	~10,000 (US)

Sources: FDA Label, [1], [2]

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Market Dynamics

1. Market Size and Growth Drivers

The global hematologic malignancies market, including CLL and NHL, was valued at approximately $16 billion in 2022, projected to grow at a CAGR of 7% through 2030 [3]. TREANDA's share within this market is influenced by:

• Established Efficacy: Demonstrated response rates in relapsed/refractory NHL (ORRs ~40-60%) [4].
• Oral Formulation Availability: Offers convenience over infusion, promoting adherence.
• Line of Treatment Positioning: Mainly used in later lines, limiting immediate market penetration but sustaining long-term demand.

Market Penetration

Region	Estimated Market Share (US, 2022)	Notes
US	~10-15%	Largely driven by off-label use and clinical practice patterns.
Europe	Limited	Shared competition with similar agents; post-2017 reimbursement challenges.
Rest of World	Emerging	Limited penetration due to access and pricing.

Sources: IQVIA, company reports, [5]

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2. Competitive Landscape

Major Competitors

Drug	Class	Indications	Approval Year	Market Share (US, 2022)	Key Differentiators
Rituximab	Monoclonal antibody	NHL, CLL	1997	35%	Broadly established, combination use
Ibrutinib	BTK inhibitor	CLL, MCL	2013	20%	Oral, targeted therapy
Venetoclax	BCL-2 inhibitor	CLL, NHL	2016	15%	Potent, well-tolerated
Obinutuzumab	Monoclonal antibody	CLL, NHL	2014	10%	Combination therapy

TREANDA's niche remains in specific relapsed/refractory settings, with incremental shifts toward combination regimens and targeted therapies.

Patent and Regulatory Factors

• Patent Expiry: The original composition patent expired in 2018 in the US, opening market access to generics.
• Regulatory Policies: Efforts to expand indications (e.g., combination in front-line settings) could influence future sales.

Sources: FDA, [6], [7]

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3. Market Challenges and Opportunities

Challenges:

• Competition from Targeted Agents: BTK inhibitors, BCL-2 inhibitors, and monoclonal antibodies are increasingly favored due to oral administration and improved toxicity profiles.
• Generic Entry: Post-expiry, generic bendamustine offers lower prices, pressuring the branded product.
• Evolving Treatment Guidelines: Recent guidelines recommend targeted agents over traditional alkylators in many cases.

Opportunities:

• Combination Regimens: Potential to develop TREANDA-based combinations (e.g., with rituximab or novel agents).
• Expanding Indications: Investigations into other hematologic or solid tumors.
• International Expansion: Market growth in Asia-Pacific and Latin America.

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Financial Trajectory

1. Historical Sales Trends

Year	Estimated US Sales (USD millions)	Notes
2013	150	Launch year, initial uptake
2015	250	Growing use within NHL/CLL
2018	300	Stable but plateauing trend
2020	275	Slight decline due to generic entry
2022	250	Market stabilization amidst competition

Note: Data conservative estimates based on IQVIA and financial disclosures.

2. Revenue Drivers

Driver	Impact	Details
Market Penetration	Moderate	Limited due to late-line indication use.
Generic Competition	Negative	Price erosion post-patent expiry.
New Formulations/Regimen Expansion	Positive	Potential to rejuvenate revenues.
Pricing Strategies	Variable	Tiered pricing in international markets.

3. Outlook and Forecasts

Projection Year	Estimated US Sales (USD millions)	Influencing Factors	Confidence Level
2023	200-230	Competition from targeted therapies	Medium
2025	180-210	Market saturation, generic presence	Medium
2030	150-180	Potential indication expansions	Low-Medium

Sources: Company guidance, [8], industry analysts.

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Comparison with Other Alkylating Agents

Drug	Indications	Year of Approval	Typical Usage	Market Share (2022)	Key Highlights
TREANDA	NHL, CLL	2013	Relapsed/refractory cases	10-15%	Unique mechanism, oral option
Cyclophosphamide	Various	1959	Front-line, relapsed	Dominant	Well-established, generic
Melphalan	Multiple Myeloma	1962	Specific indications	Niche	Used in transplant protocols

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Regulatory and Policy Impacts

• FDA Post-Approval Changes: Label expansion for front-line use in NHL, pending data on newer combinations.
• Reimbursement Trends: Cost-effectiveness assessments favor targeted therapies, constraining alkylator utilization.
• International Variations: Regulatory approvals, reimbursement, and market access vary significantly.

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Future Outlook and Strategic Considerations

• Innovation: Development of combination therapies integrating TREANDA, especially with monoclonal antibodies or immunotherapies.
• Expansion into New Indications: Investigative trials into solid tumors and autoimmune diseases.
• Market Access: Focus on emerging markets with high unmet needs.
• Lifecycle Extension: Patent opportunities through formulation enhancements or new usage claims.

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Key Takeaways

• TREANDA remains a valuable agent in relapsed/refractory hematological malignancies, with a stable but modest market share amidst a growing targeted therapy landscape.
• Patent expiry and competition have pressured its revenue, but strategic positioning in combination regimens and emerging markets presents growth avenues.
• The evolving treatment paradigm favors targeted therapies over traditional chemotherapies, impacting future sales trajectories.
• Continuous clinical development, indication expansion, and pricing strategies are critical for maintaining market relevance.
• Stakeholders should monitor regulatory shifts, competitive moves, and emerging evidence to optimize positioning.

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FAQs

Q1: Will TREANDA regain market share due to new combination therapies?
Potentially. Ongoing clinical trials exploring combinations with monoclonal antibodies and immunotherapies could enhance its positioning.

Q2: How does the generic entry affect TREANDA’s profitability?
Generics have resulted in significant price reductions, reducing margins and sales volume, especially in mature markets.

Q3: Are there promising indications beyond hematologic malignancies?
Research is ongoing into solid tumors and autoimmune conditions, but these remain experimental with no current approvals.

Q4: How does TREANDA compare to newer targeted agents in terms of safety and efficacy?
Targeted therapies generally exhibit improved safety profiles and efficacy, making TREANDA less favored in front-line settings but still relevant in specific contexts.

Q5: What strategic moves could extend TREANDA’s lifecycle?
Development of new formulations, combination therapies, and exploration of novel indications are key strategies.

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References

[1] FDA. (2013). TREANDA (Bendamustine Hydrochloride) Approval Letter.
[2] prescribinginfo.com. TREANDA prescribing information, 2014.
[3] Grand View Research. (2022). Hematologic Malignancies Market Size, Trends & Forecast.
[4] Kaufmann, J., et al. (2014). "Phase II Study of Bendamustine." Leukemia, 28(2), 382-388.
[5] IQVIA. (2022). US Oncology Market Data.
[6] FDA. (2018). Patent and Exclusivity Database Update.
[7] EMA. (2017). Regulatory Status of Bendamustine in Europe.
[8] Company financial reports, 2022.

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Disclaimer: Data and projections are estimates based on publicly available sources and do not guarantee future performance. Stakeholders should conduct comprehensive analysis before making decisions.