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Last Updated: April 19, 2025

Pemetrexed disodium - Generic Drug Details


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What are the generic drug sources for pemetrexed disodium and what is the scope of patent protection?

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-three suppliers are listed for this compound.

Summary for pemetrexed disodium
Recent Clinical Trials for pemetrexed disodium

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

SponsorPhase
Merck Sharp & Dohme Corp.Phase 3
Guangdong Association of Clinical TrialsPhase 3
Tianjin Medical University Cancer Institute and HospitalPhase 2

See all pemetrexed disodium clinical trials

Pharmacology for pemetrexed disodium
Medical Subject Heading (MeSH) Categories for pemetrexed disodium
Anatomical Therapeutic Chemical (ATC) Classes for pemetrexed disodium
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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Qilu Pharm Hainan PEMETREXED DISODIUM pemetrexed disodium POWDER;INTRAVENOUS 204890-002 May 25, 2022 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Apotex PEMETREXED DISODIUM pemetrexed disodium POWDER;INTRAVENOUS 209085-001 May 25, 2022 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sandoz PEMETREXED DISODIUM pemetrexed disodium SOLUTION;INTRAVENOUS 214657-003 May 26, 2022 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Shilpa PEMETREXED pemetrexed disodium SOLUTION;INTRAVENOUS 215179-003 May 22, 2023 RX Yes Yes 11,147,817 ⤷  Try for Free Y ⤷  Try for Free
Hetero Labs Ltd Vi PEMETREXED DISODIUM pemetrexed disodium POWDER;INTRAVENOUS 215460-001 Jun 14, 2024 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Meitheal PEMETREXED DISODIUM pemetrexed disodium POWDER;INTRAVENOUS 215479-002 Dec 13, 2022 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Prinston Inc PEMETREXED DISODIUM pemetrexed disodium POWDER;INTRAVENOUS 216582-001 Dec 11, 2023 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 7 of 7 entries

Expired US Patents for pemetrexed disodium

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007 7,772,209*PED ⤷  Try for Free
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004 5,217,974*PED ⤷  Try for Free
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004 5,344,932*PED ⤷  Try for Free
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007 5,217,974*PED ⤷  Try for Free
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004 7,772,209*PED ⤷  Try for Free
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007 5,344,932*PED ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 6 of 6 entries

Supplementary Protection Certificates for pemetrexed disodium

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0432677 7/2005 Austria ⤷  Try for Free PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
0432677 SPC/GB05/011 United Kingdom ⤷  Try for Free PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 2 of 2 entries

Market Dynamics and Financial Trajectory of Pemetrexed Disodium

The global pharmaceutical landscape has witnessed significant shifts in oncology therapeutics, with pemetrexed disodium emerging as a critical chemotherapeutic agent for treating non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma. This report synthesizes the market dynamics, growth drivers, regional trends, and financial projections shaping the future of this essential drug.


Global Market Overview and Growth Projections

The pemetrexed disodium market is characterized by steady growth, driven by rising cancer prevalence and advancements in treatment protocols. In 2022, the global market was valued at USD 2.27 billion[1], with projections indicating a rise to USD 2.61 billion by 2031 at a compound annual growth rate (CAGR) of 1.6%[1]. However, segment-specific variations reveal more dynamic trajectories. For instance, the pemetrexed disodium lyophilized powder segment, valued at USD 1.2 billion in 2022, is expected to grow at a 5.8% CAGR[2], while the injectable formulation market is projected to surge from USD 1.2 billion in 2024 to USD 2.5 billion by 2033, reflecting an 8.5% CAGR[3]. These disparities underscore the importance of disaggregating market analyses by product type and application.

The active pharmaceutical ingredient (API) segment exhibits even stronger momentum, with forecasts predicting an 11% CAGR over the next decade[4]. This growth is fueled by increasing demand for generic formulations and the expansion of oncology pipelines in emerging economies. By 2033, the pharmaceutical-grade pemetrexed disodium market alone is anticipated to reach USD 2.5 billion, growing at 9.2% annually[5].


Key Drivers of Market Expansion

Rising Cancer Burden and Aging Demographics

Lung cancer remains the third most prevalent malignancy globally, accounting for 13% of new cancer cases in the UK[1]. In the U.S., approximately 228,820 new lung cancer diagnoses were reported in 2020[3], with NSCLC representing 85% of cases[5]. The aging population amplifies this burden, as cancer incidence correlates strongly with age. By 2040, global cancer cases are expected to reach 29.5 million[5], necessitating scalable treatment solutions like pemetrexed disodium.

Technological Advancements in Drug Delivery

Innovations such as lyophilization (freeze-drying) have enhanced drug stability and shelf life, reducing storage costs and expanding access[2]. Automation and artificial intelligence (AI) are optimizing manufacturing processes, improving consistency, and reducing production errors. For example, AI-driven analytics enable precise demand forecasting, minimizing supply chain disruptions[2][8].

Regulatory Approvals and Combination Therapies

Recent approvals for combination therapies—particularly with cisplatin—have broadened pemetrexed’s clinical utility. In Europe, the European Medicines Agency’s endorsement of pemetrexed for maintenance therapy post-chemotherapy has significantly boosted adoption rates[8]. Similarly, the U.S. FDA’s fast-track designations for novel formulations are accelerating market entry[5].


Regional Market Dynamics

North America: Dominance Anchored by Healthcare Infrastructure

North America commands 40% of the global market share[4], attributable to robust oncology infrastructure and high healthcare expenditure. The U.S. alone contributes over 50% of regional revenue[8], driven by advanced diagnostic capabilities and insurance coverage for chemotherapy.

Asia-Pacific: The Fastest-Growing Region

With a 20% market share[4], Asia-Pacific is poised for rapid expansion. China’s burgeoning pharmaceutical sector, coupled with govement initiatives like the National Health Commission’s cancer screening programs, is propelling demand. India’s generic manufacturing prowess further supports affordability, with API prices averaging USD 8,000–10,000 per kilogram[10].

Europe and Emerging Markets

Europe holds 30% of the global market[4], led by Germany and France’s emphasis on personalized medicine. Latin America and the Middle East are emerging as growth frontiers, with Brazil and South Africa investing in oncology infrastructure to address rising NSCLC rates[8].


Challenges and Restraints

Cost and Accessibility Barriers

High production costs—particularly for lyophilized and injectable forms—limit accessibility in low-income regions. A single vial of pemetrexed disodium can cost USD 1,200–1,500[10], creating disparities in treatment access.

Generic Competition and Patent Expirations

Post-2025, patent expirations are expected to unleash a wave of generics, potentially eroding prices by 20–30%[5]. Indian manufacturers like Dr. Reddy’s are already capitalizing on this shift, offering cost-effective alternatives[4].

Regulatory and Supply Chain Complexities

Stringent quality controls, especially for API production, delay approvals and increase compliance costs. The COVID-19 pandemic exacerbated supply chain vulnerabilities, with 15–20% of global shipments experiencing delays in 2022–2023[5].


Financial Trajectory and Investment Opportunities

Revenue Streams and Profitability

The API segment offers the highest margins, with profitability ratios exceeding 22% for major suppliers like Qilu Pharmaceuticals[4]. Injectable formulations, despite higher production costs, generate USD 1.8 billion annually[3], driven by premium pricing in developed markets.

Strategic Investments in Emerging Markets

Companies are allocating 15–20% of R&D budgets to expand in Asia-Pacific and Latin America[8]. Local partnerships, such as Eli Lilly’s collaboration with Brazilian distributors, are enhancing market penetration[8].

Personalized Medicine and Biomarker-Driven Therapies

Investments in genomic profiling are unlocking new applications for pemetrexed disodium. For example, patients with EGFR mutations exhibit 30% higher response rates[5], creating opportunities for targeted therapy niches.


Conclusion

Pemetrexed disodium remains a cornerstone of NSCLC and mesothelioma treatment, with a market poised for sustained growth despite regulatory and competitive headwinds. Segment-specific strategies—prioritizing API production, leveraging AI in manufacturing, and expanding into high-growth regions—will be critical for stakeholders. As the global cancer burden escalates, innovations in drug delivery and personalized medicine will ensure pemetrexed’s relevance in oncology therapeutics.

“The integration of AI and automation in manufacturing is not just a trend—it’s a necessity for scaling pemetrexed production to meet global demand.”
Industry Analyst, Verified Market Reports [3]


Key Takeaways

  1. Market Growth: The pemetrexed disodium market will grow at 1.6–11% CAGR through 2031, depending on the segment.
  2. Regional Leadership: North America dominates, but Asia-Pacific is the fastest-growing region.
  3. Innovation Drivers: Lyophilization, AI, and combination therapies are key growth enablers.
  4. Challenges: Generic competition and high costs require strategic pricing and supply chain resilience.

FAQs

1. How does pemetrexed disodium compare to immunotherapy?
Pemetrexed is used in chemotherapy regimens, while immunotherapy enhances the body’s immune response. They are often combined for synergistic effects[5].

2. What factors influence API pricing?
Raw material costs, regulatory compliance, and geographic demand-supply gaps drive API prices, ranging from USD 8,000–12,000/kg[10].

3. Which companies lead pemetrexed production?
Key players include Eli Lilly (branded), Dr. Reddy’s (generics), and Qilu Pharmaceuticals (API)[4][5].

4. How has COVID-19 impacted the market?
Diagnostic delays reduced short-term demand, but long-term growth remains intact due to pent-up需求[5].

5. What role does AI play in manufacturing?
AI optimizes lyophilization cycles, reducing energy use by 15% and improving batch consistency[2][8].

References

  1. https://straitsresearch.com/report/pemetrexed-market
  2. https://sites.google.com/view/marketbridges/home/top-trending-reports/pemetrexed-disodium-lyophilized-powder-market
  3. https://www.verifiedmarketreports.com/product/pemetrexed-disodium-for-injection-market/
  4. https://github.com/DixieGrimes/Market-Research-Report-List-2/blob/main/pemetrexed-disodium-api-market.md
  5. https://www.verifiedmarketreports.com/product/pharmaceutical-grade-pemetrexed-disodium-market/
  6. https://www.sperresearch.com/report-store/Pemetrexed-Market-Insights.aspx
  7. https://www.datainsightsmarket.com/reports/pharmaceutical-grade-pemetrexed-disodium-969791
  8. https://pmarketresearch.com/product/worldwide-pemetrexed-disodium-lyophilized-powder-market-research-2024-by-type-application-participants-and-countries-forecast-to-2030/worldwide-pemetrexed-disodium-for-injection-market-research-2024-by-type-application-participants-and-countries-forecast-to-2030
  9. https://github.com/MonroeBullock54/Market-Research-Report-List-1/blob/main/pemetrexed-disodium-api-market.md
  10. https://pharmaoffer.com/api-excipient-supplier/transactions/pemetrexed-disodium
  11. https://www.precisionreports.co/global-pemetrexed-disodium-heptahydrate-market-22043610

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