PEMETREXED DISODIUM - Generic Drug Details

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

Pemetrexed disodium is the generic ingredient in three branded drugs marketed by Lilly, Accord Hlthcare, Amneal, Apotex, Baxter Hlthcare Corp, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, Nang Kuang Pharm Co, Norvium Bioscience, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, Shilpa, and Sandoz, and is included in twenty-five NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pemetrexed disodium has one patent family member in one country.

There are twenty-two drug master file entries for pemetrexed disodium. Twenty-two suppliers are listed for this compound.

Summary for PEMETREXED DISODIUM

International Patents:	1
US Patents:	1
Tradenames:	3
Applicants:	21
NDAs:	25
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	109
Patent Applications:	7,378
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEMETREXED DISODIUM
What excipients (inactive ingredients) are in PEMETREXED DISODIUM?	PEMETREXED DISODIUM excipients list
DailyMed Link:	PEMETREXED DISODIUM at DailyMed

Recent Clinical Trials for PEMETREXED DISODIUM

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 3
Guangdong Association of Clinical Trials	Phase 3
Tianjin Medical University Cancer Institute and Hospital	Phase 2

See all PEMETREXED DISODIUM clinical trials

Pharmacology for PEMETREXED DISODIUM

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

Medical Subject Heading (MeSH) Categories for PEMETREXED DISODIUM

Antineoplastic Agents

Enzyme Inhibitors

Folic Acid Antagonists

Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PEMETREXED DISODIUM

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

Paragraph IV (Patent) Challenges for PEMETREXED DISODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ALIMTA	For Injection	pemetrexed disodium	750 mg/vial	021462	1	2016-10-06
ALIMTA	For Injection	pemetrexed disodium	1000 mg/vial	021462	1	2012-06-27
ALIMTA	For Injection	pemetrexed disodium	100 mg/vial	021462	1	2008-07-01
ALIMTA	For Injection	pemetrexed disodium	500 mg/vial	021462	2	2008-02-04

US Patents and Regulatory Information for PEMETREXED DISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	202596-003	May 25, 2022	AP	RX	No	No
Biocon Pharma	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	211090-001	May 25, 2022		DISCN	No	No
Accord Hlthcare	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	203485-001	May 25, 2022	AP	RX	No	No
Fresenius Kabi Usa	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	090384-004	May 25, 2022	AP	RX	No	Yes
Baxter Hlthcare Corp	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	214436-002	Aug 18, 2022	AP	RX	No	No
Reliance Life	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	211899-001	May 25, 2022	AP	RX	No	No
Hetero Labs Ltd Vi	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	215460-002	Jun 14, 2024	AP	RX	No	No

Expired US Patents for PEMETREXED DISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	5,344,932*PED
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-002	Sep 7, 2007	5,217,974*PED
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	7,772,209*PED
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	5,217,974*PED
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-002	Sep 7, 2007	7,772,209*PED
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-002	Sep 7, 2007	5,344,932*PED

International Patents for PEMETREXED DISODIUM

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016151365

Supplementary Protection Certificates for PEMETREXED DISODIUM

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

PEMETREXED DISODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pemetrexed Disodium

Introduction to Pemetrexed Disodium

Pemetrexed disodium, commonly known by the brand name Alimta, is a chemotherapy drug used in the treatment of malignant pleural mesothelioma and non-squamous non-small cell lung cancer (NSCLC). It acts as a multi-targeted antifolate compound, disrupting folate-dependent metabolic processes essential for cell replication[5].

Market Size and Growth

The global pemetrexed market has been experiencing steady growth, driven by increasing cancer incidence and the efficacy of the drug in treating specific types of cancer.

• The global pemetrexed market size was valued at USD 2.27 billion in 2022 and is projected to reach USD 2.61 billion by 2031, growing at a CAGR of 1.6% during the forecast period (2023-2031)[4].
• Another segment, the pemetrexed diacid market, was valued at USD 4.64 billion in 2019 and is projected to reach USD 7.51 billion by 2027, growing at a CAGR of 6.7% from 2020 to 2027[3].

Geographical Segmentation

The market for pemetrexed disodium is geographically segmented, with different regions contributing significantly to its growth.

• North America: This region is the largest market for pemetrexed, driven by the high prevalence of lung cancer and the increasing demand for chemotherapy drugs. The U.S. alone accounts for a significant portion of the market due to factors such as pollution levels, lifestyle changes, and the efficiency of the drug[4].
• Asia-Pacific: This region is expected to be the fastest-growing market due to the rising number of cancer patients. Countries like China and India are seeing an increase in lung cancer cases, partly due to environmental factors and the lack of diagnostic tools[4].

Application and Product Segmentation

The market is also segmented based on application and product purity.

• Application: Pemetrexed disodium is used in the treatment of malignant pleural mesothelioma and non-squamous NSCLC. It can be administered alone or in combination with cisplatin or carboplatin[5].
• Product Purity: The market is segmented into products with purity levels of 98% and 99%. The purity level can affect the pricing and demand for the drug[1].

Drivers of Market Growth

Several factors are driving the growth of the pemetrexed disodium market.

• Increasing Cancer Incidence: The rising prevalence of lung cancer and other types of cancer that pemetrexed treats is a significant driver. For example, lung cancer is the third most prevalent cancer in the UK and the second most common in males[4].
• Efficacy and Approval: Pemetrexed has shown clinical effectiveness in extending life expectancy and improving quality of life for patients with malignant pleural mesothelioma and NSCLC. Its approval for various indications, including maintenance treatment for NSCLC, further boosts its market[2][5].
• Government Initiatives and R&D: Government initiatives and ongoing research and development activities are expected to provide opportunities for the pemetrexed market. For instance, the introduction of new formulations, such as the ready-to-dilute generic pemetrexed, enhances patient convenience and reduces contamination risks[4].

Challenges and Restraints

Despite the growth, the market faces several challenges.

• Cost-Effectiveness: Pemetrexed is expensive, which can limit its cost-effectiveness, especially at conventional thresholds. The incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) gained is high, making it less cost-effective for all patients, although it may be more cost-effective for certain subgroups[2].
• Side Effects: The drug can cause severe side effects, including skin rashes, serious lung or breathing problems, and other toxicities. These side effects can deter some patients from opting for pemetrexed, potentially slowing market growth[4].

Economic Evaluation

The economic evaluation of pemetrexed disodium is crucial for understanding its market dynamics.

• Cost-Effectiveness Analysis: Studies have shown that while pemetrexed extends life expectancy and improves quality of life, its high cost makes it less cost-effective at conventional thresholds. However, for certain patient subgroups, such as those with good performance status and advanced disease, the ICER per QALY can be more favorable[2].
• Budget Impact: The overall budget impact of pemetrexed is relatively low due to the small number of patients with mesothelioma, despite its increasing incidence. In the UK, for example, the budget impact is estimated to be around £5 million per year at current costs[2].

Market Forecast

The market forecast for pemetrexed disodium indicates continued growth, albeit at a moderate pace.

• CAGR: The global pemetrexed market is expected to grow at a CAGR of 1.6% from 2023 to 2031, reaching a market size of USD 2.61 billion by 2031[4].
• Regional Growth: North America will continue to dominate the market, while the Asia-Pacific region is expected to be the fastest-growing due to increasing cancer incidence and improving healthcare infrastructure[4].

Key Players and Competitive Landscape

The market for pemetrexed disodium is competitive, with several key players involved.

• Generic Versions: The launch of generic versions, such as the ready-to-dilute format by Sandoz, has increased competition and provided more options for patients and healthcare providers[4].
• Innovative Formulations: Key players are focusing on expanding the indications of their pemetrexed drugs and introducing new formulations to increase sales and market share[4].

Conclusion

The market for pemetrexed disodium is poised for significant growth driven by increasing cancer incidence, the drug's efficacy, and ongoing R&D activities. However, the market also faces challenges related to cost-effectiveness and side effects. Understanding these dynamics is crucial for stakeholders to make informed decisions.

Key Takeaways

• The global pemetrexed market is growing at a CAGR of 1.6% from 2023 to 2031.
• North America dominates the market, while the Asia-Pacific region is the fastest-growing.
• Pemetrexed disodium is effective in treating malignant pleural mesothelioma and NSCLC but faces challenges related to cost-effectiveness.
• The drug's high cost limits its cost-effectiveness, although it may be more favorable for certain patient subgroups.
• Ongoing R&D and government initiatives are expected to provide opportunities for market growth.

FAQs

Q: What is the primary use of pemetrexed disodium? A: Pemetrexed disodium is primarily used in the treatment of malignant pleural mesothelioma and non-squamous non-small cell lung cancer (NSCLC)[5].

Q: What is the expected market size of pemetrexed by 2031? A: The global pemetrexed market is projected to reach USD 2.61 billion by 2031[4].

Q: Which region is the largest market for pemetrexed disodium? A: North America is the largest market for pemetrexed disodium, driven by the high prevalence of lung cancer and the increasing demand for chemotherapy drugs[4].

Q: What are the significant side effects of pemetrexed disodium? A: Pemetrexed disodium can cause severe side effects, including skin rashes, serious lung or breathing problems, and other toxicities[4].

Q: Is pemetrexed disodium cost-effective? A: Pemetrexed disodium is not cost-effective at conventional thresholds for all patients, although it may be more cost-effective for certain patient subgroups with good performance status and advanced disease[2].

Cited Sources

1. Market Research Intellect: Global Pemetrexed Disodium API Market Size and Forecast.
2. PubMed: Pemetrexed disodium for the treatment of malignant pleural mesothelioma.
3. Verified Market Research: Pemetrexed Diacid Market Size | Industry Analysis | Trends | Forecast.
4. Straits Research: Pemetrexed Market Size, Share & Trends Analysis Report By.
5. MCG: Pemetrexed (Alimta®, Pemfexy™) IV.