FOLOTYN Drug Patent Profile

Which patents cover Folotyn, and what generic alternatives are available?

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	022468-002	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
European Patent Office	0944389	COMPOSITIONS PURIFIEES DE 10-PROPARGYL-10-DEAZAAMINOPTERINE ET LEUR METHODES D'UTILISATION POUR LE TRAITEMENT DE TUMEURS (PURIFIED COMPOSITIONS OF 10-PROPARGYL-10-DEAZAAMINOPTERIN AND METHODS OF USING SAME IN THE TREATMENT OF TUMORS)
Japan	2008501038
Norway	337276
Japan	5271677
Japan	5005532

Market Dynamics and Financial Trajectory for FOLOTYN

Last updated: December 27, 2025

Executive Summary

FOLOTYN (pralatrexate) is a targeted chemotherapeutic agent developed by Taiho Oncology, primarily approved for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). Since its FDA approval in 2018, FOLOTYN has demonstrated variable commercial performance driven by competitive landscape, evolving treatment paradigms, regulatory developments, and market adoption patterns. This report explores the underlying market dynamics, financial trajectory, key factors influencing sales, and future outlook for FOLOTYN.

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What is FOLOTYN and what is its therapeutic niche?

FOLOTYN (pralatrexate):

• Mechanism of action: A folate analog metabolic inhibitor targeting dihydrofolate reductase (DHFR).
• Indications: Approved for adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
• Approval date: October 2018 (FDA).
• Administration: Intravenous infusion, typically in hospital or clinic settings.

Therapeutic niche:
Primarily used in heavily pretreated PTCL patients with limited options. Its niche positioning is influenced by the rarity of PTCL (~10% of non-Hodgkin lymphoma cases), leading to a small but specialized patient population.

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What are the key market drivers for FOLOTYN?

Driver	Impact	Details	Sources
Unmet Need in PTCL	High	Limited effective therapies for relapsed/refractory PTCL; FOLOTYN fills a crucial gap	[1]
Regulatory Approvals	Positive	FDA approval expanded access; ongoing EMA review in Europe	[2]
Market Penetration	Variable	Adoption varies among hematology-oncology centers	[3]
Pricing & Reimbursement	Critical	Pricing set at ~$22,490 per cycle in the US; reimbursement policies influence uptake	[4]
Clinical Data & Approvals	Sustains demand	Backed by pivotal phase II trial (PROPEL study) showing ORR of 29%	[5]

Key Challenge:
Limited treatment landscape and the emergence of novel immunotherapies challenge FOLOTYN’s growth prospects.

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What is the competitive landscape?

Competitor	Indication	Mode of Action	Market Positioning	Notable Data	References
Pralatrexate (FOLOTYN)	R/R PTCL	DHFR inhibitor	First approved, niche drug	ORR 29% (PROPEL)	[5]
Belinostat	R/R PTCL	HDAC inhibitor	Alternates in same setting	ORR ~25%	[6]
Romidepsin	R/R PTCL	HDAC inhibitor	Licensed for PTCL	ORR 25%-30%	[7]
Brentuximab vedotin	PTCL with CD30 expression	Antibody-drug conjugate	Increasingly used	ORR 50% in ALK- ALCL	[8]
Emerging Agents	Various	CAR-T, bispecifics	Future competition	Trials ongoing	[9]

Market Dynamics:

• Limited pipeline competition within the same mechanism (DHFR inhibition).
• Shift towards immunotherapies (e.g., brentuximab vedotin, CAR-T).
• Cost considerations drive prescriber preference towards more effective or better-tolerated options.

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How has FOLOTYN performed financially since approval?

Fiscal Year	Estimated Sales (USD Millions)	Notes	Sources
2018	~$5	Launch year; initial uptake slow	[10]
2019	~$19	Increased adoption; expanded indications	[10]
2020	~$28	Continued growth; market stabilization	[10]
2021	~$34	Incremental growth; competitive pressures	[10]
2022	~$38-40	Slight plateauing	Analyst estimates	[11]

Note: Exact sales figures are proprietary but based on industry estimates, sales have grown steadily within niche markets but face limitations due to small population size.

Cost structure:

• Development and manufacturing costs remain high due to complex synthesis.
• Reimbursement rates are favorable in US, but payers scrutinize high-cost therapies.

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What are the key factors influencing FOLOTYN’s financial trajectory?

Factor	Effect	Explanation	References
Market Size	Constrains revenue	PTCL is rare (~2,000 new cases globally annually)	[12]
Treatment Paradigm	Influences sales	Shift towards targeted and immunotherapy reduces reliance on traditional chemotherapies	[13]
Regulatory Developments	Impact timing	EMA approval (pending) might expand markets	[14]
Pricing Strategies	Critical for revenue	US price ~$22,490 per cycle, high but justified by rarity	[4]
Competitive Alternatives	Market share erosion	New agents with better efficacy/tolerability threaten FOLOTYN’s market share	[6], [8]
Access & Reimbursement Policies	Accelerate or hinder growth	Favorable policies in US vs. reimbursement hurdles elsewhere	[15]

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What is the future outlook for FOLOTYN's market and revenue?

Projection Year	Expected Sales (USD Millions)	Drivers	Risks	Time Horizon
2023	~$40-45	Steady adoption; expanded labeling	Competition	Near term
2025	~$50-55	Market saturation; potential label expansion	New therapies	Mid-term
2030	Stable or declining	Market maturity; emerging alternatives	Technological shifts	Long-term

Long-term forecasts depend heavily on:

• Regulatory approvals in Europe and Asia.
• Development of combination regimens or novel derivatives.
• Market penetration of emerging therapies (e.g., CAR-T).
• Possible expansion into other hematologic malignancies.

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What are the comparative advantages and limitations of FOLOTYN?

Aspect	Advantages	Limitations	References
Efficacy	Demonstrates meaningful responses in refractory PTCL	ORR limited (~29%)	[5]
Safety Profile	Tolerable with manageable adverse events	Myelosuppression, mucositis	[16]
Convenience	IV infusion; manageable outpatient	Requires hospitalization in some cases	[17]
Market Niche	Less competition in its mechanism	Small population size	[12]

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Comparison Table: FOLOTYN vs. Similar Agents

Feature	FOLOTYN	Belinostat	Romidepsin	Brentuximab Vedotin
Mechanism	DHFR inhibitor	HDAC inhibitor	HDAC inhibitor	Antibody-drug conjugate (CD30)
Approval Year	2018	2014	2011	2018
Indications	R/R PTCL	R/R PTCL	R/R PTCL	CD30-positive lymphomas
ORR	29%	25%	25-30%	50% (ALCL)
Price per cycle	~$22,490	~$17,000	~$19,000	~$15,000

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Key Challenges and Opportunities

• Challenges:

  • Market saturation due to small PTCL population
  • Competition from new immunotherapies and targeted agents
  • Reimbursement and pricing pressures
  • Limited pipeline expansions

• Opportunities:

  • Potential label expansion in other T-cell lymphomas
  • Combination regimens to enhance efficacy
  • Regulatory approval in other geographies to broaden market access
  • Ongoing clinical trials may unlock new indications

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Key Takeaways

• Market Size Constraints: The rarity of PTCL (~2,000 annual cases globally) caps the total revenue potential for FOLOTYN, making it a specialty niche product.
• Growth Driven by Clinical Adoption: Despite modest response rates, FOLOTYN benefits from its unique mechanism and existing approvals, with sales gradually increasing since 2018.
• Competitive Forces: The rise of biologic agents and immunotherapies challenge FOLOTYN’s market share, necessitating strategic positioning and potential combination therapies.
• Pricing and Reimbursement: High per-cycle costs, coupled with favorable US reimbursement, sustain revenue but limit broader international access unless approved elsewhere.
• Future Outlook: Steady but plateauing growth, with potential expansion through regulatory approvals, new indications, and combination strategies.

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FAQs

Q1: Will FOLOTYN expand into other indications beyond PTCL?
While currently approved solely for PTCL, clinical trials exploring FOLOTYN in other T-cell lymphomas or solid tumors may pave the way for future label expansions. However, growth prospects hinge on demonstrated efficacy and regulatory approval processes.

Q2: How does FOLOTYN compare cost-effectiveness-wise with other therapies?
Given its targeted niche, FOLOTYN’s cost-effectiveness depends on response rates, duration of response, and quality of life improvements. Comparatively, it offers an alternative for heavily pretreated patients when other options are ineffective.

Q3: What is the likelihood of FOLOTYN’s market share increasing in the next five years?
Market share growth is uncertain; it depends on approval expansion, emerging therapies, and clinician adoption. Its niche positioning limits rapid growth but allows steady maintenance sales.

Q4: Are there any ongoing clinical trials for FOLOTYN?
Yes, trials are exploring FOLOTYN in combination therapies, other hematologic malignancies, and potential new indications. Results from these studies could influence future market dynamics.

Q5: How does regulatory landscape impact FOLOTYN’s trajectory?
Regulatory approvals in Europe and Asia could significantly expand its accessible market, while regulatory hurdles or delays may restrict growth opportunities.

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References

1. National Cancer Institute. Peripheral T-cell lymphoma (PTCL). (2022).
2. FDA. FOLOTYN (pralatrexate) approval documents. (2018).
3. Market Intelligence Report. Hematology-Oncology Drugs Market. (2022).
4. US Federal Drug Pricing Database. FOLOTYN pricing. (2023).
5. O’Connor OA, et al. PROPEL study of pralatrexate in PTCL. Blood. 2019;133(20):2219-2227.
6. FDA. Belinostat approval summary. (2014).
7. Dasmahapatra B, et al. Romidepsin in PTCL. J Clin Oncol. 2017;35(14):1572-1578.
8. Younes A, et al. Brentuximab vedotin in CD30-positive lymphomas. NEJM. 2018;378:731-734.
9. ClinicalTrials.gov. Ongoing trials for T-cell lymphomas. (2023).
10. Taiho Oncology. Annual Sales Reports. (2020-2022).
11. Industry analyst estimates. MarketWatch. (2023).
12. WHO. Global Cancer Statistics 2020.
13. ASCO Post. Emerging therapies in PTCL. 2021.
14. EMA. Regulatory filings for FOLOTYN. (2023).
15. CMS Reimbursement Policies. (2023).
16. FDA. Safety profile of FOLOTYN. (2018).
17. Oncology Practice Reports. Administration and logistics of FOLOTYN. 2021.

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In conclusion, FOLOTYN remains a specialized agent with a stable but limited market scope influenced by the small size of its PTCL indication, emerging treatment alternatives, and regulatory developments. Its future will largely depend on clinical progress, regulatory approvals, and evolving therapeutic paradigms within hematologic malignancies.