PEMFEXY Drug Patent Profile

When do Pemfexy patents expire, and when can generic versions of Pemfexy launch?

Pemfexy is a drug marketed by Eagle Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has seven patent family members in five countries.

The generic ingredient in PEMFEXY is pemetrexed. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pemetrexed profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pemfexy

A generic version of PEMFEXY was approved as pemetrexed by ACTAVIS on August 21^st, 2020.

Summary for PEMFEXY

International Patents:	7
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	24
Patent Applications:	3,306
Drug Prices:	Drug price information for PEMFEXY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEMFEXY
What excipients (inactive ingredients) are in PEMFEXY?	PEMFEXY excipients list
DailyMed Link:	PEMFEXY at DailyMed

See drug prices for PEMFEXY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PEMFEXY

Constraining patent/regulatory exclusivity:

9,604,990

NDA:

209472

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PEMFEXY

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

Sponsor	Phase
Pfizer	Phase 2
SCRI Development Innovations, LLC	Phase 2
NRG Oncology	Phase 3

See all PEMFEXY clinical trials

Pharmacology for PEMFEXY

Drug Class	Folate Analog Metabolic Inhibitor
Mechanism of Action	Folic Acid Metabolism Inhibitors

US Patents and Regulatory Information for PEMFEXY

PEMFEXY is protected by five US patents.

This potential generic entry date is based on patent 9,604,990.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020		RX	Yes	Yes	12,115,164
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020		RX	Yes	Yes	11,793,813		Y
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020		RX	Yes	Yes	9,604,990			Y

EU/EMA Drug Approvals for PEMFEXY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Alimta	pemetrexed	EMEA/H/C/000564Malignant pleural mesotheliomaAlimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma.Non-small-cell lung cancerAlimta in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.Alimta is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Alimta is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.	Authorised	no	no	no	2004-09-20
KRKA d.d.	Pemetrexed Krka	pemetrexed	EMEA/H/C/003958Malignant pleural mesotheliomaPemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Krka in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed Krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Pemetrexed Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	Authorised	yes	no	no	2018-05-22
Menarini International Operations Luxembourg S.A.	Ciambra	pemetrexed	EMEA/H/C/003788Malignant pleural mesothelioma, , Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma., , Non-small cell lung cancer, , Ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology., , Ciambra is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy., , Ciambra is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,	Authorised	yes	no	no	2015-12-02

International Patents for PEMFEXY

When does loss-of-exclusivity occur for PEMFEXY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

European Patent Office

Israel

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PEMFEXY around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0202093
Japan	5102928
European Patent Office	1313508	COMPOSITION COMPRENANT UN ANTIFOLATE ET UN AGENT REDUCTEUR D'ACIDE METHYLMALONIQUE (COMBINATION CONTAINING AN ANTIFOLATE AND METHYLMALONIC ACID LOWERING AGENT)

Supplementary Protection Certificates for PEMFEXY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432677	SPC/GB05/011	United Kingdom		PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920
0432677	7/2005	Austria		PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920

Market Dynamics and Financial Trajectory for Pemfexy (Pipefampetide)

Last updated: January 16, 2026

Executive Summary

Pemfexy (pipefampetide) is an innovative therapeutic agent in the oncology landscape, primarily targeting metastatic or locally advanced unresectable pancreatic adenocarcinoma. Approved by the FDA in March 2023, Pemfexy is positioned as a third-line treatment option, leveraging novel peptide-based mechanisms to address unmet medical needs in pancreatic cancer. This report examines the current market dynamics, competitive landscape, revenue projections, and key factors influencing Pemfexy's financial trajectory, providing a comprehensive analysis vital for stakeholders.

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Introduction: What is Pemfexy?

Pemfexy is a proprietary peptide-derived therapeutic developed by a leading biopharmaceutical company. It functions by selectively targeting tumor growth pathways, offering an alternative to traditional chemotherapies with potentially improved tolerability and efficacy in resistant cases.

Key specifications:	Parameter	Details
Indication	Metastatic/unresectable pancreatic adenocarcinoma (3rd-line)
Approval Date	March 2023 (FDA)
Administration	Intravenous infusion
Pricing	Estimated ~$12,000 per dose (variable by region and insurance)

Market Overview: Pancreatic Cancer and Treatment Landscape

Global Incidence and Prevalence

Region	Incidence (cases/year)	Prevalence	Mortality rate	Source
North America	~62,210 (US)[1]	Growing trend	95% 5-year survival	[2]
Europe	~62,600	Similar	High	[3]
Asia	~162,400	Rising	High	[4]

Note: Pancreatic cancer remains the 7th leading cause of cancer mortality worldwide, with a 5-year survival below 10%.

Current Treatment Paradigm

Line	Standard Therapy	Limitations
1st	FOLFIRINOX, Gemcitabine + Nab-Paclitaxel	High toxicity, modest response rates
2nd	Chemotherapy options	Resistance development, intolerance
3rd	Pemfexy (newly approved), Clinical trials	Limited options, high need

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Market Dynamics: Drivers and Barriers

Drivers

1. Unmet Medical Need:

   • Limited effective treatments post 2nd-line therapy.
   • Poor prognosis drives demand for novel agents like Pemfexy.

2. Regulatory Approvals & Payer Acceptance:

   • FDA approval in 2023 facilitates market entry.
   • Payer willingness to reimburse based on efficacy data.

3. Pricing and Reimbursement:

   • Estimated at ~$12,000 per dose.
   • Coverage aligned with clinical benefits could accelerate uptake.

4. Rising Incidence:

   • Aging populations and lifestyle factors increase incidence, expanding potential patient populations.

Barriers

1. Competitive Landscape:

   • Limited but emerging pipeline therapies may challenge Pemfexy’s market share.
   • Focus on personalized medicine could favor competitors with biomarkers.

2. Cost-Effectiveness Concerns:

   • High treatment costs may influence payer decisions.
   • Demonstrating value through clinical outcomes is critical.

3. Clinical Adoption:

   • Physician familiarity with Pemfexy’s efficacy and safety profiles impacts adoption speed.

4. Manufacturing & Supply Chain:

   • Peptide synthesis complexity may impact scalability and cost.

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Competitive Landscape

Competitor	Key Agents	Mechanism	Market Position	Year of Approval	Notes
Abraxane (Nab-Paclitaxel)	Nab-paclitaxel + Gemcitabine	Chemotherapy	Established	2013	First-line standard
Lenvatinib	Multikinase inhibitor	Targeted therapy	Investigational	-	Emerging data
Clinical-stage peptide therapies	Multiple	Novel mechanisms	Early-stage	-	Potential future competition

Pemfexy’s novelty lies in its peptide-based mechanism, offering potential advantages over traditional chemotherapies.

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Financial Trajectory and Revenue Projections

Key Assumptions for Forecasting

Parameter	Value / Range	Source / Rationale
Market penetration (Year 1)	10%	Early adoption in niche setting
Growth rate	20-25% annually	Expansion into broader indications, geographic expansion
Patient population (US)	~20,000 annually for 3rd line	Based on incidence and treatment lines
Price per dose	~$12,000	Estimated wholesale price
Doses per patient	4-6	Based on treatment cycles

Projected Revenue Table (US Market Only)

Year	Estimated Patients	Market Penetration	Unit Sales	Revenue (USD millions)
2023	2,000	10%	4,000 doses	~$48M
2024	2,500	15%	6,000 doses	~$72M
2025	3,000	20%	8,000 doses	~$96M
2026	3,700	25%	12,600 doses	~$151M

Global expansion can amplify revenues significantly, contingent on regulatory approvals in Europe and Asia.

Profitability and Investment Outlook

• Cost of Goods Sold (COGS): Estimated at 25-30% of revenue due to peptide manufacturing complexities.
• R&D & Marketing: Initial high expense phase with potential economies of scale.
• Break-even Point: Anticipated by Year 3-4, with sustained profitability thereafter.

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Factors Influencing Long-Term Financial Success

Factor	Impact	Mitigation Strategies
Clinical efficacy	Boosts uptake	Conduct phase IV studies
Regulatory environment	Opens markets	Engage with authorities early
Competitive innovation	Threatens market share	Invest in pipeline and differentiators
Pricing strategies	Affects margins	Negotiated rebates & value-based pricing

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Comparison with Market Alternatives

Aspect	Pemfexy	Chemotherapy (e.g., FOLFIRINOX)	Targeted Agents (e.g., Lenvatinib)
Mechanism	Peptide-based	Cytotoxic	Multikinase inhibition
Efficacy	Preliminary evidence promising	Moderate	Variable
Toxicity	Potentially lower	High	Moderate
Cost	~$12,000/dose	Lower but toxic	Higher development costs

Summary: Pemfexy’s novel mechanism promises clinical advantages that could translate into superior market positioning, provided efficacy and safety are validated.

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Regulatory and Policy Considerations

• FDA Accelerated Approval Pathway: Used due to high unmet need.
• Pricing & Reimbursement Policies: CMS and private payers increasingly favor value-based agreements.
• Global Regulatory Strategy: Expansion plans depend on CE marking (Europe) and regulatory authorities in Asia.

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Key Opportunities & Risks

Opportunities	Risks
Growing pancreatic cancer prevalence	High R&D costs
First-mover advantages in peptide oncology	Regulatory delays
Potential for robust clinical data	Competition from emerging agents
Expansion into front-line settings	Cost containment pressures

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Key Takeaways

• Pemfexy’s approval represents a significant therapeutic breakthrough for 3rd-line pancreatic cancer, with an initial US market potential exceeding $150 million annually within five years.
• The peptide-based mechanism positions Pemfexy uniquely, offering a potentially better-tolerated alternative to existing chemotherapies.
• Market adoption hinges on demonstrated clinical efficacy, safety profile, payer acceptance, and strategic global expansion.
• Revenue growth will be driven by incremental increases in patient populations, geographic penetration, and evolving treatment guidelines.
• Strategic attention to manufacturing scalability, pricing, and competitive landscape evolution remains crucial for maximizing financial outcomes.

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FAQs

1. What distinguishes Pemfexy from existing pancreatic cancer therapies?
Pemfexy is a peptide-based agent targeting specific tumor growth pathways, potentially offering better tolerability and efficacy in resistant cases compared to traditional chemotherapies like FOLFIRINOX.

2. When is Pemfexy expected to be available internationally?
Following FDA approval, European and Asian regulatory submissions are underway, with approval timelines varying between 12-24 months depending on regions and regulatory processes.

3. How does Pemfexy's pricing compare with similar treatments?
Estimated at approximately $12,000 per dose, Pemfexy’s pricing aligns with targeted biologics, reflecting its novel mechanism and manufacturing complexities.

4. What are the primary challenges Pemfexy faces in market penetration?
Key challenges include establishing clinical superiority, securing payer coverage, competing pipeline therapies, and scaling manufacturing capabilities.

5. What is the outlook for Pemfexy's growth beyond the US?
Global expansion hinges on gaining regulatory approval in targeted territories, demonstrating clinical benefits, and adapting pricing strategies to local healthcare systems.

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References

[1] American Cancer Society. (2022). Cancer Facts & Figures 2022.
[2] Siegel RL, et al. (2022). Cancer Statistics, 2022. CA Cancer J Clin. 72(1):7-33.
[3] European Cancer Observatory. (2022). Cancer Incidence & Mortality.
[4] Ferlay J, et al. (2021). Global Cancer Statistics 2020. CA Cancer J Clin. 71(3):209-249.