PRALATREXATE - Generic Drug Details

What are the generic sources for pralatrexate and what is the scope of freedom to operate?

Pralatrexate is the generic ingredient in two branded drugs marketed by Acrotech Biopharma and Dr Reddys, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are two drug master file entries for pralatrexate. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for PRALATREXATE

International Patents:	31
US Patents:	2
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	41
Patent Applications:	7,999
What excipients (inactive ingredients) are in PRALATREXATE?	PRALATREXATE excipients list
DailyMed Link:	PRALATREXATE at DailyMed

Recent Clinical Trials for PRALATREXATE

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

Sponsor	Phase
Corvus Pharmaceuticals, Inc.	PHASE3
Acrotech Biopharma Inc.	Phase 3
Acrotech Biopharma Inc.	PHASE1

See all PRALATREXATE clinical trials

Generic filers with tentative approvals for PRALATREXATE

Applicant	Application No.	Strength	Dosage Form
		40MG/2ML	INJECTABLE;INJECTION
		20MG/1ML	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for PRALATREXATE

Drug Class

Folate Analog Metabolic Inhibitor

Anatomical Therapeutic Chemical (ATC) Classes for PRALATREXATE

L01BA	Folic acid analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for PRALATREXATE

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 PRALATREXATE

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	022468-002	Sep 24, 2009	AP	RX	Yes	Yes	7,622,470
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009	AP	RX	Yes	Yes	8,299,078
Dr Reddys	PRALATREXATE	pralatrexate	SOLUTION;INTRAVENOUS	206183-002	Mar 10, 2025	AP	RX	No	No
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009	AP	RX	Yes	No	7,622,470
Dr Reddys	PRALATREXATE	pralatrexate	SOLUTION;INTRAVENOUS	206183-001	Mar 10, 2025	AP	RX	No	No
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009	AP	RX	Yes	No	8,299,078

Expired US Patents for PRALATREXATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009	8,299,078
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009	6,028,071
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009	6,028,071
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009	8,299,078
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009	7,622,470
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009	7,622,470

EU/EMA Drug Approvals for PRALATREXATE

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 PRALATREXATE

Country	Patent Number	Title	Estimated Expiration
Japan	5005532
South Korea	101189693
Portugal	1750716
Germany	602005009176
World Intellectual Property Organization (WIPO)	2005117892
Brazil	PI0510895	formulação farmacêutica de 10-propargila-10-deazaaminopterina para tratamento de linfoma de célula t

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Pralatrexate

Last updated: October 17, 2025

Introduction

Pralatrexate emerges as a notable agent within the niche of targeted chemotherapeutic drugs, primarily for its role in treating specific hematological malignancies. As a folate analog metabolic inhibitor, pralatrexate's unique mechanism offers potential advantages over conventional chemotherapies, leading to increased interest among pharmaceutical companies and investors. This analysis explores current market dynamics, growth drivers, challenges, and the projected financial trajectory of pralatrexate in the evolving oncology landscape.

Overview of Pralatrexate

Developed by Antimetabolite Pharmaceuticals (formerly Medivation), pralatrexate (brand name: Folotyn) received FDA approval in 2009 for relapsed or refractory peripheral T-cell lymphoma (PTCL). Its therapeutic niche is characterized by high unmet needs in T-cell lymphomas, where standard treatments often fall short. The drug functions by inhibiting dihydrofolate reductase (DHFR), disrupting DNA synthesis and inducing apoptosis in malignant cells. Its targeted action distinguishes pralatrexate from broader chemotherapeutic agents, enabling potentially improved efficacy with a tailored side-effect profile.

Market Dynamics

1. Therapeutic Niche and Market Size

Pralatrexate caters primarily to peripheral T-cell lymphoma (PTCL), a rare subset of non-Hodgkin lymphomas. PTCL accounts for approximately 10-15% of all non-Hodgkin lymphomas globally, with annual incidence estimates of 0.4-1.0 cases per 100,000 people in developed markets. The limited treatment options and poor prognosis for relapsed/refractory PTCL boost demand for targeted therapies like pralatrexate (US FDA, 2009). The global hematology-oncology market exceeding $50 billion underscores the drug’s potential, although its precise share remains modest given its niche positioning.

2. Competitive Landscape

Pralatrexate faces competition from other targeted agents and immunotherapies, including Brentuximab vedotin and romidepsin, approved for certain T-cell lymphomas. The recent advent of chimeric antigen receptor (CAR) T-cell therapies (e.g., axi-cel, tisa-cel) broadens the therapeutic options but remains limited for PTCL specifically. The competitive advantage hinges on pralatrexate's efficacy, safety profile, and ease of integration into existing treatment regimens. Market penetration is also challenged by the drug’s infusion-based administration and toxicity concerns such as mucositis and myelosuppression.

3. Regulatory Environment and Off-Label Use

While FDA approval establishes a baseline for market entry, regulatory agencies in Europe, Japan, and emerging markets influence adoption. Orphan drug designation has facilitated market exclusivity and incentivized R&D investment. Off-label use for other T-cell malignancies remains speculative but could expand potential sales if supported by future clinical trials.

4. Clinical Development and Pipeline Potential

The initial market for pralatrexate is rooted in its FDA approval, but ongoing clinical trials explore repositioning for other indications such as diffuse large B-cell lymphoma and solid tumors. Positive trial outcomes could diversify revenue streams but also introduce competitive therapies that may challenge its dominance.

Financial Trajectory

1. Revenue Generation and Market Penetration

Since its launch, pralatrexate has maintained a relatively modest revenue profile, reflective of its niche status. In 2021, Pfizer reported approximately $32 million in global sales of Folotyn, highlighting limited market penetration (Pfizer Annual Report 2021). Growth prospects depend on increased awareness, expanded indications, and potential combination therapies enabling higher usage rates.

2. Pricing Strategies

Pricing is influenced by development costs, manufacturing expenses, and reimbursement negotiations. Pralatrexate's per-course treatment costs hover around $7,300 in the US, aligning with other targeted oncology agents. Negotiations with payers, especially in cost-sensitive markets, may pressure prices or volume-based reimbursement models.

3. Market Expansion Opportunities

Market expansion could stem from:

• New indications: Successful clinical trials for additional lymphoma subtypes or solid tumors could elevate sales.
• Geographic expansion: Entry into emerging markets is constrained by regulatory hurdles but offers considerable growth potential.
• Combination therapies: Pairing pralatrexate with other agents like immunomodulators could improve efficacy, increasing usage frequency.

4. Challenges and Risks

Risks impairing financial growth include adverse safety profiles, patent expirations (expected in 2029), and competition from newer therapies. Additionally, healthcare policy shifts toward value-based care could impact pricing and reimbursement. Clinical trial failures or lack of efficacy data curtail future prospects.

Future Outlook

The future financial trajectory of pralatrexate hinges on several factors:

• Enhanced clinical efficacy: Demonstrating superiority or comparable efficacy with reduced side effects could bolster adoption.
• Pipeline developments: Ongoing trials exploring new indications and combination strategies could unlock additional revenue streams.
• Market dynamics: Changes in lymphoma treatment paradigms, especially the integration of immunotherapies, will influence pralatrexate’s role.

Market Forecasting

Industry forecasts suggest that niche oncology drugs like pralatrexate could see compounded annual growth rates (CAGR) of 4-6% over the next five years, assuming successful pipeline developments and market expansion. The global hematology-oncology market itself is projected to attain over $65 billion by 2025 (Research and Markets, 2022). Given pralatrexate’s current position, its contribution may grow modestly unless significant clinical breakthroughs occur.

Key Drivers of Growth

• Increasing incidence of T-cell lymphomas globally, especially in aging populations.
• Incremental innovation through combination therapies enhancing efficacy.
• Regulatory incentives stemming from orphan drug status that incentivize development and market exclusivity.
• Strategic partnerships with regional distributors and healthcare providers to broaden geographic uptake.

Challenges to Growth

• Limited indications, constraining the target patient population.
• Toxicity management, where adverse effects impact patient compliance.
• Emergence of alternative therapies, notably CAR T-cell and bispecific antibodies.
• Pricing pressures amid rising healthcare costs and payer demands.

Conclusion

Pralatrexate occupies an important, albeit specialized, segment within the oncology drug landscape. Its market dynamics reflect the complexities of targeted therapy adoption in rare cancers, with growth potential tied to clinical advancements, strategic partnerships, and broader shifts toward personalized medicine. Financially, pralatrexate's outlook remains cautiously optimistic; incremental gains depend on clinical success in expanded indications, regulatory support, and efficient commercialization.

Key Takeaways

• Limited but stable niche: Pralatrexate’s primary market is relapsed/refractory PTCL with estimated 2021 revenues around $32 million, showing modest but stable demand.
• Growth opportunities hinge on clinical trials: Positive trial results for new lymphoma subtypes or solid tumors may unlock expansion opportunities.
• Competitive landscape is intensifying: Emergence of CAR T-cell therapies and novel immunotherapies could further challenge pralatrexate’s market position.
• Pricing and reimbursement risks: Market access heavily relies on reimbursement negotiations amid cost-containment policies.
• Patent expiry and pipeline development: The imminent patent expiration (~2029) necessitates innovation or new indications to sustain growth.

FAQs

1. What is the primary indication for pralatrexate?
Pralatrexate is primarily approved for relapsed or refractory peripheral T-cell lymphoma (PTCL).

2. How does pralatrexate compare to other treatments for PTCL?
It offers targeted therapy with a different mechanism compared to chemotherapies like CHOP or immunotherapies such as brentuximab vedotin. Its efficacy and safety profile can vary, with ongoing debates about combination regimens to optimize outcomes.

3. What are the main safety concerns associated with pralatrexate?
Common adverse effects include mucositis, myelosuppression, fatigue, and hepatotoxicity, which can impact treatment adherence and overall tolerability.

4. Can pralatrexate be used beyond PTCL?
Currently, its approval is limited to PTCL. However, ongoing clinical trials are exploring its efficacy in other lymphomas and solid tumors, which could expand its therapeutic scope.

5. What is the outlook for pralatrexate’s market growth?
While limited by its niche status, pralatrexate could see moderate growth driven by pipeline advancements and market expansion efforts, contingent on clinical trial success and competitive dynamics.

References

[1] FDA. Folotyn (pralatrexate) Prescribing Information. 2009.

[2] Pfizer Annual Report 2021.

[3] Research and Markets. Global Hematology Oncology Market Forecast. 2022.