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.

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

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	24
Patent Applications:	5,427
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
Columbia University	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

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

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	022468-001	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
Austria	407677
Canada	2260266	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)
Germany	69738981
Denmark	0944389
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)
European Patent Office	1891957

Last updated: July 22, 2026

FOLOTYN (pralatrexate) Market Dynamics and Financial Trajectory: Uptake, Decline, and Patent/Generic Threats

FOLOTYN (pralatrexate) is an oncology drug in the antifolate class that reached commercialization in the US through limited indication coverage for relapsed or refractory peripheral T-cell lymphoma (PTCL) after at least one prior therapy. Financial performance has been structurally constrained by (1) narrow label, (2) high switching and treatment-line uncertainty across hematologic oncology, (3) changing standards of care, and (4) a patent and exclusivity profile that leaves generic entry risk and market share erosion as major long-term dynamics.

Bottom line: FOLOTYN’s revenue trajectory is characterized by limited peak scale, then sustained pressure from competition in PTCL, evolving regimen preferences, and the long-run payoff profile of an aging, niche oncology asset.

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What is FOLOTYN (pralatrexate) used for, and how does label scope drive revenue ceilings?

Core indication (US): relapsed or refractory peripheral T-cell lymphoma (PTCL) after at least one prior therapy.
Therapeutic positioning: single-agent chemotherapy-like agent in a small, heterogeneous lymphoma population where patient volume is fragmented by subtype and geography.

How do PTCL subtype fragmentation and sequencing affect uptake?

FOLOTYN’s market size depends less on overall “lymphoma growth” and more on:

• Relapse timing and prior exposure patterns (post-prior-therapy eligibility).
• Subtypes and practice variability across academic and community oncology.
• Treatment sequencing where clinicians may prefer newer combinations, immunotherapies, or transplant approaches depending on fitness and line.

Why does a narrow label limit financial upside?

• Hematologic oncology is line- and subtype-dependent; FOLOTYN’s eligible pool is smaller than in broad solid-tumor indications.
• The market does not benefit from a “treat-every-patient” dynamic.
• Market share is exposed to faster substitution when alternative options show better response or tolerability.

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When does FOLOTYN face market exclusivity expiry and patent expiration risk?

Financial trajectory in niche oncology drugs often tracks two time anchors: (1) patent and exclusivity end dates, and (2) practical substitution timelines once generic or biosimilar-like competition becomes viable. For FOLOTYN, the practical risk is driven by small molecule generic pathways under the Hatch-Waxman framework (not biosimilar).

What patents protect FOLOTYN, and which are relevant to commercial erosion?

The revenue-relevant layers typically include:

• Composition-of-matter patents on pralatrexate.
• Formulation and solid-state or manufacturing-process patents (where present).
• Method-of-use patents aligned to lymphoma treatment regimens.

These layers determine whether a generic can launch quickly or whether it can launch “at risk” while litigation proceeds.

What matters most for generic entry scenarios?

• Whether the Orange Book lists active patents tied to FOLOTYN products.
• Whether those patents have expired or are still enforceable in the US.
• Whether paragraph IV filings force settlement or delayed launch.

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What is the Orange Book status of FOLOTYN, and what does it imply for generics?

Featured snippet answer: Orange Book status determines the US patent landscape for generic timing. For FOLOTYN, the legal listing status and remaining unexpired patents dictate whether an FDA-approved generic can launch immediately, enter at risk, or face enforced exclusivity via settlement.

How does Orange Book linkage control FDA approval timing?

• If unexpired listed patents exist for the approved drug, ANDA approval is typically blocked until expiration.
• If a paragraph IV certification is made against listed patents, the FDA approval can proceed if litigation timing allows; otherwise, a stay can apply through the statutory framework.

Market impact channels

• Price pressure once generics launch.
• Reimbursement and formulary substitution in oncology infusion practices.
• Hospital purchasing inertia that may slow or accelerate uptake of the lowest-cost option.

(Practically, FOLOTYN’s narrow patient pool means even small uptake shifts can move revenue sharply.)

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How strong is the patent estate for FOLOTYN, and what does that do to long-term revenue?

A strong estate can preserve pricing and volume, but in niche oncology the revenue ceiling is still dominated by clinical adoption and patient counts. For an older drug like pralatrexate, patent strength is still important because it governs duration of premium pricing and prevents early generic competition.

What patent features typically protect niche oncology spend?

• Multiple overlapping expiry horizons (composition plus method-of-use).
• Extended protection through formulation/manufacturing patents.
• Settlements that delay ANDA launches even when some patents are weak.

What happens when the estate weakens?

• Loss of exclusivity typically triggers accelerated switching, especially when payers and institutions standardize on generics.
• The remaining branded segment often becomes “account-anchored” rather than label-anchored.

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What generic entry risks exist for FOLOTYN, and what Paragraph IV challenge dynamics apply?

What is the typical ANDA pathway for a small molecule like pralatrexate?

• Generic manufacturer files an ANDA with paragraph IV certifications to relevant Orange Book patents.
• A notice triggers litigation with the brand company.
• The FDA approval timeline depends on statutory triggers, including potential court decisions and settlement outcomes.

How do settlement agreements change financial trajectory?

When the brand settles, it effectively buys:

• A delayed launch date.
• Often a defined “carve-out” that limits design-around.
• In some cases, shared promotional or supply arrangements (rare, but possible in small molecule deals).

For FOLOTYN-style niche oncology, even one early generic entrant can quickly reduce branded revenue due to concentrated purchasing.

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How does FOLOTYN compare with competing PTCL therapies, and how does that affect sales?

FOLOTYN competes in a landscape where outcomes and regimen preferences evolve. Market dynamics for pralatrexate are influenced by substitution risk when clinicians move toward:

• Alternative chemotherapy regimens with better tolerability windows.
• Novel agents in PTCL.
• Approaches tied to transplant or targeted immunotherapies (depending on subtype and line).

What competitive levers typically shift patient volume away from FOLOTYN?

• Response rate and durability against specific PTCL subtypes.
• Safety profile and supportive-care burden.
• Operational feasibility (administration setting, monitoring intensity, outpatient schedule).

How do oncology treatment trends translate to revenue patterns?

• Revenue can plateau even without generic entry if new standards shift clinician behavior.
• Revenue declines can start years before exclusivity expiry when substitution accelerates through clinical guideline updates and payer adoption.

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What regulatory milestones and FDA considerations shaped FOLOTYN’s commercial ramp?

For niche oncology, the commercial ramp depends on:

• FDA label scope and any restricted language.
• The presence or absence of expedited review decisions and the nature of approval endpoints.
• Post-marketing safety signals that can influence uptake.

What drives ongoing formulary inclusion after launch?

• Real-world adherence to supportive measures.
• Dose modifications and toxicity management requirements.
• Hospital and payer comfort with administration and monitoring workflow.

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What financial trajectory pattern does FOLOTYN show after launch, and what drives it?

Revenue drivers that usually dominate for pralatrexate

1. Patient identification and sequencing: PTCL heterogeneity and prior-therapy constraints.
2. Clinical switching: comparative effectiveness versus newer alternatives.
3. Exclusivity and generic substitution: pricing and formulary movement after patent expiry.
4. Operational fit: infusion center adoption and administration logistics.

Revenue patterns common in niche oncology

• Early revenue ramp when centers learn the regimen and when clinicians test it in eligible relapsed PTCL.
• Plateau as clinicians converge on preferred alternatives for different PTCL subtypes.
• Downward drift once:
  • standard-of-care shifts,
  • payer coverage narrows to preferred options, and
  • generic threat crystallizes.

For FOLOTYN, the market dynamics fit this “small market, high substitution optionality” model: the ceiling is structurally low, and competitive forces can compress the brand premium faster than in large-prevalence indications.

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What does FOLOTYN’s financial trajectory imply for investors and licensors?

Commercial implications

• FOLOTYN’s risk profile is tied more to competitive substitution and payer-driven standardization than to broad incidence growth.
• Revenue sustainability is sensitive to timing of exclusivity and the introduction of lower-cost alternatives.

Licensing and acquisition logic

• A niche branded oncology drug can still be attractive for:
  • acquisition of rights with a protected period,
  • revenue optimization through better contracting and restricted distribution,
  • strategic settlements that extend exclusivity value.
• The downside is limited growth headroom: the license value depends heavily on how long premium pricing can last.

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Key timelines: what to monitor for FOLOTYN market turning points

Revenue turning points for FOLOTYN typically align with:

• Orange Book patent status updates: listing additions or removals can change generic risk posture.
• ANDA paragraph IV litigation milestones: court rulings or settlement announcements.
• FDA approval announcements for generic pralatrexate: launch date drives immediate price pressure.
• Clinical guideline changes in PTCL: substitution risk can start well before generic entry.

(These are the operational levers that determine whether branded sales stabilize, decline gradually, or drop sharply.)

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Key Takeaways

• FOLOTYN’s market is constrained by a narrow PTCL label and sequencing dependence, limiting ceiling revenue even before exclusivity expires.
• Financial trajectory is driven by substitution risk from evolving PTCL standards of care and payer/institution formularies.
• Patent and Orange Book status governs the timing of generics, which can accelerate revenue erosion once premium pricing is undermined.
• The primary “watch items” for revenue are exclusivity/patent events, paragraph IV litigation outcomes, and any generic launch that triggers procurement-driven switching.

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FAQs

1) What typically happens to FOLOTYN pricing and volume when generic pralatrexate launches?
Expect rapid price compression and formulary switching, with branded remaining share concentrated in accounts with delayed procurement standardization.

2) Do formulation or method-of-use patents usually delay generic entry for pralatrexate?
They can, if still listed in the Orange Book and successfully asserted in paragraph IV litigation, but timing depends on which listed patents remain unexpired and enforceable.

3) How much does PTCL heterogeneity limit FOLOTYN addressable market?
It reduces eligible patient volume by subtype and prior-therapy patterns, making revenue sensitive to clinical sequencing rather than overall lymphoma incidence.

4) What competitive signals predict earlier revenue decline for FOLOTYN?
Guideline updates that shift relapse management, payer policies that prefer alternative regimens, and measurable adoption of competing agents in relapsed PTCL.

5) Which market events are most likely to cause abrupt FOLOTYN revenue drops?
A generic launch with minimal launch barriers, an unfavorable court ruling in paragraph IV litigation, or a settlement that ends brand exclusivity earlier than expected.

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References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. (n.d.). Paragraph IV certification and ANDA litigation framework overview. FDA. https://www.fda.gov/