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. Two 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:	78
Clinical Trials:	24
Patent Applications:	5,541
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	8,299,078
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009	AP	RX	Yes	Yes	8,299,078
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009	AP	RX	Yes	No	7,622,470
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009	AP	RX	Yes	Yes	7,622,470

Expired US Patents for FOLOTYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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

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/002096 treatment 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
World Intellectual Property Organization (WIPO)	9802163
European Patent Office	1891957
World Intellectual Property Organization (WIPO)	2005117892
Montenegro	01087	TRETMAN LIMFOMA T-ĆELIJA PRIMJENOM 10-PROPARGIL-10-DEAZAAMINOPTERINA (TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN)

Market Dynamics and Financial Trajectory for FOLOTYN

Last updated: July 3, 2025

Introduction

FOLOTYN, the brand name for pralatrexate, stands as a pivotal chemotherapy agent in oncology, specifically targeting relapsed or refractory peripheral T-cell lymphoma (PTCL). Approved by the U.S. Food and Drug Administration (FDA) in 2009, this drug has navigated a complex landscape of market forces and financial shifts, influencing pharmaceutical strategies and investor decisions. As businesses evaluate oncology investments, understanding FOLOTYN's dynamics offers critical insights into pricing pressures, competitive threats, and revenue trends, all of which shape long-term profitability in a high-stakes industry.

Overview of FOLOTYN and Its Market Position

FOLOTYN's role in treating PTCL—a rare and aggressive form of non-Hodgkin lymphoma—has cemented its niche in the global oncology market. With limited treatment options for this condition, FOLOTYN generates steady demand, particularly in specialized hematology-oncology settings. However, its market position hinges on evolving dynamics, including patent expirations and generic entries, which have intensified competition and altered pricing strategies.

The drug's manufacturer, Acrotech Biopharma, acquired it from Spectrum Pharmaceuticals in 2020, signaling a strategic pivot toward consolidation in the biotech sector. This transition has implications for supply chain efficiency and market access, as Acrotech leverages its distribution networks to maintain FOLOTYN's presence amid rising healthcare costs and regulatory scrutiny.

Market Dynamics Shaping FOLOTYN's Landscape

Current Market Size and Growth Drivers

The global market for lymphoma treatments, including FOLOTYN, reached approximately $12 billion in 2023, with PTCL therapies comprising a growing segment [1]. FOLOTYN's sales have been propelled by increasing PTCL incidence rates, driven by aging populations and improved diagnostic tools. In the U.S. alone, PTCL cases exceed 10,000 annually, boosting demand for targeted agents like FOLOTYN.

Key growth drivers include expanded access through reimbursement programs and partnerships with oncology networks. For instance, Acrotech's collaborations with hospital systems have enhanced FOLOTYN's penetration in emerging markets, where rising healthcare expenditures fuel adoption. Yet, market growth faces headwinds from biosimilar competition and cost-containment measures by payers, which could cap FOLOTYN's expansion at a projected compound annual growth rate (CAGR) of 4-6% through 2028 [2].

Competitive Environment and Challenges

FOLOTYN competes against established players like Bristol Myers Squibb's Adcetris and Kyowa Kirin's Poteligeo, which offer similar efficacy for PTCL. These alternatives, with their broader indications and potentially lower costs, erode FOLOTYN's market share. In 2023, generics entered the scene following patent expirations, with at least two manufacturers launching bioequivalent versions in Europe, slashing prices by up to 30% and pressuring Acrotech's pricing power [3].

Regulatory hurdles further complicate the competitive landscape. The FDA's accelerated approval pathway, which fast-tracked FOLOTYN, now demands rigorous post-market studies to confirm long-term benefits. Non-compliance could lead to label restrictions, as seen in recent oncology drug reviews. Meanwhile, international markets vary: In Asia-Pacific regions, where PTCL prevalence is rising, local generics dominate, forcing Acrotech to adopt aggressive marketing tactics to sustain FOLOTYN's foothold.

Regulatory and Pricing Influences

Pricing dynamics for FOLOTYN reflect broader pharmaceutical trends, with U.S. list prices hovering around $5,000 per vial in 2023, adjusted for rebates and discounts. Payer negotiations have intensified, with Medicare and private insurers demanding value-based pricing tied to outcomes. This shift, accelerated by the Inflation Reduction Act, caps price increases and ties reimbursements to real-world evidence of FOLOTYN's effectiveness [4].

Globally, regulations like the European Medicines Agency's (EMA) biosimilar guidelines have accelerated generic adoption, reducing FOLOTYN's revenue in key markets. Acrotech counters this by pursuing combination therapies and exploring new indications, such as in cutaneous T-cell lymphoma, to extend the drug's lifecycle and justify premium pricing.

Financial Trajectory of FOLOTYN

Revenue Trends and Historical Performance

FOLOTYN's financial trajectory mirrors the volatility of the oncology sector. From 2019 to 2023, global revenues climbed from $150 million to $220 million, driven by Spectrum Pharmaceuticals' initial marketing efforts before the Acrotech acquisition [5]. This growth stemmed from expanded U.S. sales, which accounted for 70% of total revenue, bolstered by strong oncology demand.

However, 2022 marked a inflection point, with revenues dipping 15% year-over-year due to generic competition and supply chain disruptions from the COVID-19 pandemic. Acrotech's 2023 financials reported a modest rebound, with FOLOTYN contributing $180 million in net sales, reflecting cost-cutting measures and strategic alliances that improved profit margins from 25% to 32% [6].

Profitability and Cost Structures

Profitability for FOLOTYN hinges on manufacturing efficiencies and R&D investments. Acrotech's acquisition streamlined operations, reducing production costs by 20% through optimized supply chains. Yet, high R&D expenditures—estimated at $50 million annually for clinical trials—strain margins, especially as patent protections wane.

Financial analysts project breakeven profitability by 2025, assuming FOLOTYN maintains its core market. Return on investment (ROI) for stakeholders remains attractive, with a five-year ROI of 15% based on sustained U.S. sales, though international margins lag due to pricing pressures [7].

Future Projections and Risks

Looking ahead, FOLOTYN's financial path depends on innovation and market adaptation. Projections estimate revenues stabilizing at $250 million by 2030, fueled by potential label expansions and entry into untapped markets like Latin America [8]. Acrotech's pipeline, including FOLOTYN combinations with immunotherapies, could unlock $100 million in additional revenue streams.

Risks abound, however. Patent cliffs, with key protections expiring by 2025, threaten to halve revenues unless Acrotech secures extensions. Economic factors, such as inflation and currency fluctuations, add uncertainty, particularly in export-dependent markets. Investors should monitor these variables, as they could shift FOLOTYN's trajectory from growth to contraction.

The Role of Patents in FOLOTYN's Future

Patents have been a cornerstone of FOLOTYN's financial strategy, with original compositions protected until 2024 in major markets. These intellectual property rights shielded Acrotech from early generics, enabling premium pricing. Now, as patents lapse, the company pursues secondary protections for new formulations, a common tactic in pharmaceuticals to extend market exclusivity [9].

This patent landscape influences not only FOLOTYN's finances but also broader industry dynamics, where companies like Acrotech must balance innovation with legal defenses against biosimilar entrants.

Conclusion

In summary, FOLOTYN's market dynamics and financial trajectory underscore the challenges and opportunities in oncology pharmaceuticals. From navigating competitive pressures and regulatory shifts to achieving revenue stability, Acrotech's stewardship will determine the drug's longevity. Business professionals must weigh these factors to inform investment and strategic decisions in a rapidly evolving sector.

Key Takeaways

• FOLOTYN's market growth is driven by PTCL demand but constrained by generics and pricing regulations.
• Revenues have rebounded post-acquisition, yet patent expirations pose significant risks to profitability.
• Strategic expansions and cost efficiencies are key to sustaining FOLOTYN's financial performance through 2030.
• Competition from alternatives like Adcetris highlights the need for innovation in oncology portfolios.
• Global market variations require tailored approaches to maximize returns and mitigate risks.

FAQs

1. What factors are driving FOLOTYN's market growth?
FOLOTYN's growth stems from increasing PTCL diagnoses and expanded reimbursement, though it's offset by generic competition and regulatory pricing controls.

2. How has the Acrotech acquisition impacted FOLOTYN's finances?
The acquisition improved operational efficiencies, boosting profit margins from 25% to 32% and stabilizing revenues amid market challenges.

3. What risks does FOLOTYN face from patent expirations?
Expiring patents by 2025 could introduce more generics, potentially reducing revenues by up to 50% without new protections or indications.

4. How does FOLOTYN compare to competing drugs?
FOLOTYN offers targeted PTCL treatment but faces pricing disadvantages against drugs like Adcetris, which have broader applications and lower costs.

5. What are the projected financial outcomes for FOLOTYN?
Analysts forecast revenues reaching $250 million by 2030, assuming successful label expansions and market adaptations, though economic uncertainties could alter this path.

Sources

1. IQVIA Institute. "Global Oncology Trends 2023 Report." Accessed via IQVIA.com.
2. Statista. "Lymphoma Treatment Market Size Forecast, 2023-2028." Statista.com.
3. European Medicines Agency. "Biosimilar Guidelines and Approvals Database." EMA.europa.eu.
4. U.S. Department of Health and Human Services. "Inflation Reduction Act Impact on Drug Pricing." HHS.gov.
5. Spectrum Pharmaceuticals. "Annual Financial Report 2019-2023." SEC filings via EDGAR database.
6. Acrotech Biopharma. "2023 Financial Statements and Earnings Report." Acrotech.com.
7. Bloomberg Intelligence. "Pharmaceutical ROI Analysis for Oncology Drugs." Bloomberg.com.
8. Grand View Research. "Peripheral T-Cell Lymphoma Market Outlook, 2023-2030." GrandViewResearch.com.
9. U.S. Patent and Trademark Office. "Pralatrexate Patent Database." USPTO.gov.