FOLOTYN Drug Patent Profile

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

Folotyn is a drug marketed by Acrotech Biopharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-one patent family members in twenty-three countries.

The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the pralatrexate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Folotyn

A generic version of FOLOTYN was approved as pralatrexate by DR REDDYS on March 10^th, 2025.

Summary for FOLOTYN

International Patents:	31
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	24
Patent Applications:	6,117
Drug Prices:	Drug price information for FOLOTYN
What excipients (inactive ingredients) are in FOLOTYN?	FOLOTYN excipients list
DailyMed Link:	FOLOTYN at DailyMed

See drug prices for FOLOTYN

Recent Clinical Trials for FOLOTYN

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

Sponsor	Phase
Acrotech Biopharma Inc.	Phase 3
City of Hope Medical Center	Phase 1/Phase 2
Jennifer Amengual	Phase 3

See all FOLOTYN clinical trials

Pharmacology for FOLOTYN

Drug Class

Folate Analog Metabolic Inhibitor

Paragraph IV (Patent) Challenges for FOLOTYN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOLOTYN	Injection	pralatrexate	20 mg/mL and 40 mg/2 mL	022468	4	2013-09-24

US Patents and Regulatory Information for FOLOTYN

FOLOTYN 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
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009	AP	RX	Yes	No
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009	AP	RX	Yes	Yes
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009	AP	RX	Yes	No
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009	AP	RX	Yes	Yes

Expired US Patents for FOLOTYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009

EU/EMA Drug Approvals for FOLOTYN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Allos Therapeutics Ltd	Folotyn	pralatrexate	EMEA/H/C/002096treatment of peripheral T-cell lymphoma,	Refused	no	no	yes		2012-06-21

International Patents for FOLOTYN

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

Country	Patent Number	Title	Estimated Expiration
Japan	5005532
Germany	69738981
Spain	2313365
European Patent Office	1750716	TRAITEMENT DU LYMPHOME T UTILISANT 10-PROPARGYL-10-DEAZAAMINOPTERINE (TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN)
Poland	1750716

Market Dynamics and Financial Trajectory for FOLOTYN

Last updated: July 27, 2025

Introduction

FOLOTYN (pralatrexate) emerges as a pioneering targeted therapy in the management of peripheral T-cell lymphoma (PTCL), a rare and aggressive form of non-Hodgkin lymphoma. Since its FDA approval in 2018, FOLOTYN has garnered attention for its unique mechanism—an antifolate agent designed to inhibit DNA synthesis selectively in malignant cells. This analysis explores the intricate market dynamics shaping FOLOTYN's commercial landscape and forecasts its financial trajectory amid evolving oncology treatment paradigms.

Market Overview of PTCL and Therapeutic Landscape

Peripheral T-cell lymphoma accounts for approximately 10-15% of non-Hodgkin lymphomas globally, with an incidence rate escalating annually due to improved diagnostic capabilities and demographic shifts [1]. Despite its rarity, PTCL’s aggressive nature and poor prognosis—particularly following relapse—generate significant unmet medical needs.

Treatment options historically centered on chemotherapy regimens such as CHOP, with limited durable responses. The advent of targeted therapies like FOLOTYN introduces a paradigm shift, offering new hope for relapsed/refractory (R/R) PTCL patients. The drug's approval by the FDA in 2018 positioned it as a vital therapeutic asset, especially following the limitations of conventional treatments [2].

Market Dynamics

1. Competitive Landscape

FOLOTYN operates in a niche yet fiercely competitive domain. The primary competitors for R/R PTCL include:

• Romidepsin (Istodax): An HDAC inhibitor approved for R/R PTCL, with a different mechanism but similar setting.
• Belantamab Mafodotin: Emerging in broader lymphomas but not yet approved specifically for PTCL.
• Emerging immunotherapies and combination regimens: Such as CAR-T cell therapies and novel monoclonal antibodies.

While FOLOTYN’s mechanism—folate antagonist specificity—offers advantages, its market share faces pressure from these options, especially as the therapeutic landscape shifts toward immunotherapy and combination regimens.

2. Regulatory and Labeling Developments

Initial FDA approval of FOLOTYN was based on phase II trials demonstrating meaningful response rates (~29%). Subsequent trials and real-world data have underscored its efficacy and manageable safety profile [3]. Ongoing regulatory reviews in Europe and other jurisdictions are likely to expand its geographic reach, potentially increasing sales.

The authorization of combination regimens, such as FOLOTYN with other agents, could enhance efficacy, broadening its indication spectrum and market penetration.

3. Pricing and Reimbursement

FOLOTYN is positioned in the high-cost oncology drug segment, with average wholesale prices (AWP) estimated around $20,000–$30,000 per treatment cycle. Reimbursement depends on healthcare system policies, with broader adoption linked to demonstrated cost-effectiveness in prolonging progression-free survival (PFS) and improving quality of life [4].

Negotiations with payers and inclusion in treatment guidelines will significantly influence patient access, especially in markets with cost-containment pressures.

4. Market Penetration and Adoption Drivers

Factors influencing adoption include:

• Physician familiarity: As more clinicians recognize FOLOTYN’s benefits, uptake increases.
• Patient eligibility: Its role is particularly relevant for patients refractory to prior therapies.
• Real-world evidence (RWE): Growing data supporting efficacy and safety can bolster confidence among prescribers.
• Patient advocacy and clinical guidelines: Inclusion in NCCN guidelines will catalyze broader use.

5. Challenges and Barriers

Barriers to market expansion include:

• Limited durability of response: Median responses typically last months, necessitating combination strategies.
• Toxicity profile: Myelosuppression and mucositis require management, possibly limiting use in frail populations.
• Market size constraints: Rarity of PTCL caps the overall upside unless indications expand or new indications emerge.

Financial Trajectory

1. Revenue Projections

Given its initial niche position, forecasted revenue trajectories suggest moderate growth in the next five years. The driving factors include:

• Market Penetration Rate: Estimated at 15-25% among eligible R/R PTCL patients in high-income regions.
• Sales Per Patient: Approximately $50,000–$100,000 annually, accounting for dosing variability.
• Global Expansion: Entry into Europe, Asia, and other markets could double or triple accessible patient pools.

Assuming a conservative adoption rate, industry analysts project FOLOTYN’s global sales could reach $150–$300 million annually by 2028, contingent on approval timelines and clinical outcomes [5].

2. Milestone-Driven Revenues

Partnerships with biotech firms or licensing agreements with regional distributors can supplement revenues. Additionally, approval for broadening indications—such as other T-cell lymphomas or combination therapies—could significantly amplify revenues.

3. Cost Considerations

Development costs for subsequent trials, label expansion, and post-market surveillance are factors influencing net profits. However, as a marketed product, operating margins are primarily driven by manufacturing, marketing, and pharmacovigilance expenses.

4. Potential for Market Expansion

Innovative combination therapies involving FOLOTYN and emerging immunomodulators or targeted agents could carve out new segments, elevating its financial profile. Moreover, the integration of personalized medicine approaches may optimize dosing and treatment sequencing, enhancing profitability.

Regulatory and Market Outlook

The global oncology drug market is poised for compounded growth at a CAGR of approximately 8-10% over the next decade, driven by novel targeted therapies and immunotherapies [6]. FOLOTYN’s niche market share is likely to expand modestly, especially if ongoing trials demonstrate superior outcomes or broader indications are approved.

Regulatory agencies' increasing openness to accelerated approval pathways and real-world evidence integration will further influence its market trajectory. Strategic collaborations for research and development could accelerate lifecycle management and revenue growth.

Key Takeaways

• FOLOTYN occupies a critical role in addressing unmet needs in R/R PTCL, with its targeted mechanism providing a therapeutic advantage.
• The drug’s market growth will be moderated by the rarity of PTCL, competitive therapies, and reimbursement landscape challenges.
• Expansion into European, Asian, and broader markets, alongside ongoing clinical trials, are pivotal for revenue escalation.
• Combining FOLOTYN with other modalities may extend its use and enhance financial prospects.
• A cautious yet optimistic outlook predicts revenues reaching up to $300 million annually by 2028, contingent on clinical and regulatory success.

FAQs

1. What are the key factors driving FOLOTYN’s market adoption?
Physician familiarity, demonstration of clinical efficacy, manageable safety profile, inclusion in clinical guidelines, and reimbursement coverage primarily influence adoption.

2. How does FOLOTYN compare with other therapies in R/R PTCL?
While offering a targeted approach with notable response rates, FOLOTYN’s response durability and side effect profile are factors influencing its relative positioning compared to agents like romidepsin.

3. Are there ongoing trials to broaden FOLOTYN’s indications?
Yes, studies are ongoing to evaluate FOLOTYN in combination therapies and expanded indications within T-cell lymphomas.

4. What geographic markets present the greatest growth opportunities?
Europe and Asia, especially countries with expanding healthcare infrastructure and unmet oncology needs, offer the most substantial growth potential.

5. What impact might future combination therapies have on FOLOTYN’s market?
Combining FOLOTYN with immunomodulators or monoclonal antibodies could improve response rates and durability, thereby expanding its market and increasing revenue.

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Sources
[1] International Agency for Research on Cancer. "Globocan 2020: Lymphomas."
[2] U.S. Food and Drug Administration. “FOLOTYN (pralatrexate) approval memo.”
[3] National Cancer Institute. "Pralatrexate in the Treatment of Peripheral T-cell Lymphoma."
[4] Market Research Future. "Global Oncology Drug Market Analysis."
[5] IBISWorld Reports. "Pharmaceuticals Market Outlook."
[6] Grand View Research. "Oncology Drugs Market Size and Forecast."