Drugs in MeSH Category Antineoplastic Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	211083-001	Jul 2, 2020		DISCN	No	No
Hikma	EVEROLIMUS	everolimus	TABLET;ORAL	206133-001	Apr 12, 2018	AB	RX	No	No
Endo Operations	EVEROLIMUS	everolimus	TABLET;ORAL	205775-002	Oct 18, 2021	AB	RX	No	No
Theravia	SIKLOS	hydroxyurea	TABLET;ORAL	208843-002	Dec 21, 2017		RX	Yes	Yes
Hikma	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208339-001	Oct 31, 2018	AB	RX	No	No
Accord Hlthcare	PEMETREXED DISODIUM	pemetrexed disodium	SOLUTION;INTRAVENOUS	214408-004	Jul 19, 2022		RX	Yes	Yes

Antineoplastic Agents Market Analysis and Financial Projection

The global market for anti-neoplastic agents is experiencing robust growth, driven by rising cancer prevalence and technological innovations, while a dynamic patent landscape reflects intense competition and strategic IP maneuvers. Here's a detailed analysis:

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Market Dynamics

Growth Projections and Valuation

• The anti-neoplastic pharmaceutical agents market was valued at $10.1 billion in 2022, projected to reach $28.8 billion by 2032 at an 11% CAGR [1].
• Broader anti-neoplastic agents (including non-pharmaceutical categories) reached $108 billion in 2021 and are expected to hit $233 billion by 2028 (7.5% CAGR) [6][13].
• Oncology drugs, a key segment, are forecasted to grow from $202.3 billion in 2023 to $530.4 billion by 2032, driven by targeted therapies and immunotherapies [12].

Key Growth Drivers

1. Rising Cancer Incidence: Over 238,000 new lung cancer cases in the U.S. in 2023 alone highlight demand [10].
2. Technological Advancements: Innovations in mRNA therapeutics (e.g., lipid nanoparticle delivery systems) and nanotechnology (polymer/protein-based nanoparticles) enhance treatment efficacy [4][11][14].
3. Government Initiatives: Policies supporting affordable cancer care and R&D investments accelerate market expansion [1][6].

Market Restraints

• High Treatment Costs: Monthly prices for targeted therapies remain prohibitive in many regions [8].
• Awareness Gaps: Limited understanding of neoplasm symptoms in developing nations delays diagnosis and treatment [1].

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Patent Landscape

Strategic Patenting Trends

1. Formulation Innovations:

   • Patent 6,987,108 (Schering Corp.) covers dissolvable formulations of antineoplastic agents using urea or amino acids [2].
   • Patent 6,838,464 (AstraZeneca) protects pyrimidine derivatives as inhibitors of CDK/FAK kinases, critical for cell cycle regulation [7].

2. Delivery Systems:

   • mRNA cancer therapeutics dominate with 650+ patents held by leaders like Moderna (lipid nanoparticles) and Pfizer (mRNA stability enhancements) [4].
   • Nanoparticle patents focus on polymers and proteins to improve drug targeting and reduce side effects [11][14].

3. Evergreening Tactics:

   • Originators extend exclusivity via secondary patents (e.g., method-of-use claims). Example: Celgene prolonged market monopoly for a drug by patenting combination therapies [9].

Regional Patent Activity

• U.S. Dominance: 350+ mRNA patents due to regulatory flexibility and R&D investment [4].
• Europe and Asia: 250 and 150 mRNA patents, respectively, driven by collaborative research and government funding [4].

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Competitive and Regulatory Landscape

Key Players

• Top Innovators: Roche, Pfizer, Novartis, and Johnson & Johnson lead with portfolios spanning biologics, small molecules, and biosimilars [6][12].
• Biosimilar Challenges: Expiring biologics patents (e.g., trastuzumab) face litigation, delaying generics. However, biosimilars are gaining traction with new formulations [5].

Emerging Opportunities

• Personalized Medicine: mRNA therapies enable tailored treatments, with self-amplifying vaccines holding 400+ patents for enhanced immune responses [4].
• Nanotechnology: Over 14 years of patent filings highlight nanoparticles as a priority for improving drug solubility and tumor targeting [11][14].

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Future Outlook

The market will hinge on balancing innovation with affordability. While evergreening and high costs pose barriers, advancements in nanotechnology, mRNA platforms, and biosimilars promise transformative outcomes. Collaborative IP strategies and regulatory reforms will shape accessibility, particularly in emerging economies.

"The extended monopoly for originator drugs, averaging 28 years, underscores the need for policies that encourage competition without stifling innovation." [9]

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Key Takeaways

• Anti-neoplastic markets are expanding rapidly due to unmet clinical needs and R&D breakthroughs.
• Patent strategies increasingly focus on delivery mechanisms and secondary uses to prolong exclusivity.
• Nanotechnology and mRNA platforms represent the next frontier in oncology therapeutics.

References

1. https://www.futuremarketinsights.com/reports/anti-neoplastic-pharmaceutical-agents-market
2. https://www.drugpatentwatch.com/p/patent/6987108
3. https://meshb.nlm.nih.gov/record/ui?ui=D000964
4. https://www.globenewswire.com/news-release/2025/03/11/3040828/28124/en/mRNA-Cancer-Therapeutics-Patent-Landscape-Report-and-Forecast-2024-2032-Featuring-Pfizer-Moderna-and-Novartis-with-650-Patents-Combined.html
5. https://pmc.ncbi.nlm.nih.gov/articles/PMC7188399/
6. https://www.fnfresearch.com/anti-neoplastic-agents-market
7. https://www.drugpatentwatch.com/p/patent/6838464
8. https://pubmed.ncbi.nlm.nih.gov/21606435/
9. http://bulletin.mfd.org.mk/volumes/Volume%2068_3/68_3_254.pdf
10. https://www.thebusinessresearchcompany.com/report/lung-cancer-drugs-global-market-report
11. https://plus.cobiss.net/cobiss/adz/en/discovery/eNo1j8tKw0AUQAdRbKld-AMyP5A4c3Pn5U6LLyi60XW5mdxKJE2GzHTh31sQdwcOHDhCXGtVozbmNiWqNdbozsQSFNrKBwsLsc75WymlNTgf_KVYgEEfgsaleHijcUo0lz4OnCWlNPTcyTJJGks_8pQGyicp6YvHku8kyUTlhHKgscuREl-Jiz0NmdfivMxHXonPp8ePzUu1fX9-3dxvqwjelCqERocWIvlonY5gA0eHTlnjFPpm32Gj2uicQYvsG44KggOrW9cxggFYiZu_bjq2B-52ae4PNP_s_l_gF131SIE
12. https://www.globenewswire.com/news-release/2025/03/17/3043832/0/en/Oncology-Drugs-Market-Size-to-Surpass-USD-530-39-Billion-by-2032-Driven-by-Advancements-in-Targeted-Therapies-and-Rising-Cancer-Incidence-SNS-Insider.html
13. https://www.researchandmarkets.com/reports/5931024/anti-neoplastic-agents-global-market-report
14. https://vpinstitute.org/nanoparticles-applied-to-antineoplastic-agents-a-patent-landscape/

Last updated: 2025-03-25