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 two 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:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	24
Patent Applications:	5,239
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 two 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	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/000564 Malignant 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/003958 Malignant 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/003788 Malignant 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
Fresenius Kabi Deutschland GmbH	Pemetrexed Fresenius Kabi	pemetrexed	EMEA/H/C/003895 Malignant pleural mesotheliomaPemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Fresenius Kabi 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 Fresenius Kabi 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 Fresenius Kabi 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	2016-07-22
medac Gesellschaft für klinische Spezialpräparate mbH	Pemetrexed medac	pemetrexed	EMEA/H/C/003905 Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma., , Non-small cell lung cancer Pemetrexed medac 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 medac 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 medac 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	2015-11-26
Actavis Group PTC ehf	Armisarte (previously Pemetrexed Actavis)	pemetrexed	EMEA/H/C/004109 Malignant pleural mesotheliomaPemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed 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 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 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	2016-01-18

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
Spain	2284660
World Intellectual Property Organization (WIPO)	0202093
Japan	5469706
Germany	60127970
European Patent Office	1313508	COMPOSITION COMPRENANT UN ANTIFOLATE ET UN AGENT REDUCTEUR D'ACIDE METHYLMALONIQUE (COMBINATION CONTAINING AN ANTIFOLATE AND METHYLMALONIC ACID LOWERING AGENT)
Canada	2962383	FORMES CRISTALLINES DU DIACIDE DE PEMETREXED ET LEURS PROCEDES DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR)

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

PEMFEXY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PEMFEXY

Introduction

PEMFEXY, a branded alternative to ALIMTA®, is a significant player in the pemetrexed market, which is driven by the increasing prevalence of lung cancer and mesothelioma. Here, we delve into the market dynamics and the financial trajectory of PEMFEXY, highlighting key factors influencing its growth and performance.

Market Overview of Pemetrexed

The global pemetrexed market, valued at USD 2.27 billion in 2022, is projected to reach USD 2.61 billion by 2031, growing at a CAGR of 1.6% during the forecast period (2023-2031)[1][4].

Role of PEMFEXY in the Pemetrexed Market

PEMFEXY, developed by Eagle Pharmaceuticals, received final approval from the FDA in 2020, marking a significant milestone in the pemetrexed market. This approval allowed PEMFEXY to enter the market as a branded alternative to ALIMTA®, Eli Lilly's pemetrexed product[5].

Market Growth Drivers

Several factors are driving the growth of the pemetrexed market, and by extension, PEMFEXY:

Increasing Prevalence of Lung Cancer and Mesothelioma

The rising incidence of non-small cell lung cancer (NSCLC) and pleural mesothelioma is a key driver. According to the American Cancer Society, approximately 235,760 new cases of lung cancer were estimated in the U.S. in 2021, with NSCLC accounting for 80% to 85% of all lung cancer diagnoses[1].

Technological Advancements and Combination Therapies

Technological advancements in biopharmaceuticals and the growing adoption of combination therapies for cancer treatment are also propelling market growth. Pemetrexed's efficacy in combination with other treatments enhances its market position[4].

Geographical Trends

The Asia-Pacific region is emerging as the fastest-growing market due to rapid industrialization, urbanization, and increasing healthcare expenditure in countries like China and India. However, North America, particularly the U.S., remains a dominant market for pemetrexed and PEMFEXY[1][4].

Financial Performance of PEMFEXY

Revenue and Market Share

As of 2022, Eagle Pharmaceuticals held an approximate 6% share of the commercial segment of the pemetrexed market with PEMFEXY, generating about $8 million in revenue per quarter. The company anticipates doubling this share by the end of Q1 2023, valuing this segment at approximately $550 million annually at expected pricing[3].

Royalty Adjustments

Eagle Pharmaceuticals reduced future royalties on PEMFEXY profits from 25% to a range of 0% to 12.5% in exchange for a one-time payment of $15 million. This move is expected to enhance the profitability of PEMFEXY sales in 2023 and beyond[3].

Sales Projections

The company expects higher PEMFEXY sales in 2023 compared to 2022. This growth is part of Eagle Pharmaceuticals' broader strategy to diversify its revenue streams and maintain strong financial performance[3].

Financial Guidance and Outlook

Adjusted EBITDA and Earnings Per Share

For 2023, Eagle Pharmaceuticals projects an adjusted EBITDA of $74.0-$80.0 million and adjusted non-GAAP earnings per share of $4.20-$4.53. These projections are based on several key drivers, including increased PEMFEXY sales and reduced royalties[3].

Cash Flow and Debt

As of December 31, 2022, Eagle Pharmaceuticals had $55.3 million in cash and cash equivalents, $72.4 million in accounts receivable, and $63.8 million in outstanding debt. The company's financial health is supported by its robust cash flow and strategic debt management[2].

Competitive Landscape

Market Competition

PEMFEXY competes in a market dominated by ALIMTA®, but Eagle Pharmaceuticals' strategic moves, such as reducing royalties and expanding market share, are positioning PEMFEXY as a significant competitor. The company's bendamustine franchise, while facing competition, has maintained a strong market share, indicating Eagle's ability to navigate competitive landscapes effectively[2][3].

Regulatory Environment

The approval of PEMFEXY by the FDA following the settlement of patent litigation with Eli Lilly was a critical regulatory milestone. However, stringent regulatory approval processes for new drug formulations can pose challenges to market growth[5].

Conclusion

The market dynamics for PEMFEXY are driven by the increasing prevalence of lung cancer and mesothelioma, technological advancements, and the growing adoption of combination therapies. Eagle Pharmaceuticals' strategic financial moves, such as reducing royalties and expanding market share, are expected to enhance the financial trajectory of PEMFEXY.

Key Takeaways

• Market Growth: The global pemetrexed market is growing at a CAGR of 1.6% from 2023 to 2031.
• Revenue Projections: PEMFEXY is expected to see higher sales in 2023, with Eagle Pharmaceuticals aiming to double its market share.
• Royalty Adjustments: Reduced royalties from 25% to 0% to 12.5% are expected to boost profitability.
• Financial Health: Strong cash flow and strategic debt management support Eagle Pharmaceuticals' financial health.
• Regulatory Environment: FDA approval and settlement of patent litigation are key regulatory milestones.

FAQs

What is PEMFEXY used for?

PEMFEXY is a chemotherapy drug used in the treatment of malignant pleural mesothelioma and non-squamous non-small cell lung cancer (NSCLC).

Who developed PEMFEXY?

PEMFEXY was developed by Eagle Pharmaceuticals.

What is the current market share of PEMFEXY?

As of 2022, Eagle Pharmaceuticals held an approximate 6% share of the commercial segment of the pemetrexed market with PEMFEXY.

How does the reduction in royalties impact PEMFEXY's profitability?

The reduction in royalties from 25% to 0% to 12.5% in exchange for a one-time payment of $15 million is expected to enhance the profitability of PEMFEXY sales.

What are the projected financial outcomes for Eagle Pharmaceuticals in 2023?

Eagle Pharmaceuticals projects an adjusted EBITDA of $74.0-$80.0 million and adjusted non-GAAP earnings per share of $4.20-$4.53 for 2023.

Sources

1. Straits Research: Pemetrexed Market Size, Share & Trends Analysis Report By ...
2. Eagle Pharmaceuticals, Inc.: Annual Report 2022
3. Eagle Pharmaceuticals, Inc.: Eagle Pharmaceuticals Provides Business Update and Guidance for 2023
4. Cognitive Market Research: Global Pemetrexed Market Report
5. Business Wire: Eagle Pharmaceuticals Reports First Quarter 2020 Results