Physiological Effect: Decreased Mitosis

Drugs with Physiological Effect: Decreased Mitosis

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mountain	GRISEOFULVIN, ULTRAMICROSIZE	griseofulvin, ultramicrosize	TABLET;ORAL	204371-001	Jan 9, 2014	AB	RX	No	No
Padagis Us	PODOFILOX	podofilox	SOLUTION;TOPICAL	075600-001	Jan 29, 2002	AT	RX	No	No
Padagis Us	PODOFILOX	podofilox	GEL;TOPICAL	211871-001	Nov 22, 2023	AB	RX	No	No
Sandoz	GRISEOFULVIN, ULTRAMICROSIZE	griseofulvin, ultramicrosize	TABLET;ORAL	202805-001	Dec 26, 2018	AB	RX	No	No
Sandoz	GRISEOFULVIN, ULTRAMICROSIZE	griseofulvin, ultramicrosize	TABLET;ORAL	202805-002	Dec 26, 2018	AB	RX	No	No
Sigmapharm Labs Llc	GRISEOFULVIN,ULTRAMICROSIZE	griseofulvin, ultramicrosize	TABLET;ORAL	202545-001	Oct 22, 2012	AB	RX	No	No
Sigmapharm Labs Llc	GRISEOFULVIN,ULTRAMICROSIZE	griseofulvin, ultramicrosize	TABLET;ORAL	202545-002	Oct 22, 2012	AB	RX	No	No

Decreased Mitosis Market Analysis and Financial Projection

The market for drugs that decrease mitosis, particularly mitotic inhibitors and related anticancer therapies, is experiencing significant growth driven by rising cancer prevalence and pharmaceutical innovation. Here's a detailed analysis of market dynamics and patent trends:

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Market Dynamics

Growth Projections

• The global mitotic inhibitors market is projected to grow from $8.6 billion in 2023 to $16.2 billion by 2033 (CAGR ~6.5%), driven by demand for oncology therapies targeting breast, lung, and blood cancers[1][16].
• The antitumor antibiotics market (e.g., doxorubicin, mitomycin C) is expected to expand from $4.27 billion in 2024 to $6.63 billion by 2033 (CAGR 4.92%)[3].

Key Drivers

1. Rising Cancer Burden: Breast cancer remains a primary focus, with mitotic inhibitors widely used in adjuvant and metastatic settings[16].
2. Advancements in Drug Delivery:
   • Liposomal formulations and antibody-drug conjugates (ADCs) improve efficacy while reducing cardiotoxicity[3][13].
   • Example: Trastuzumab emtansine (ADC combining HER2-targeted antibody with microtubule inhibitor DM1)[13].
3. Regional Growth:
   • North America: Leads with ~40% market share due to high healthcare spending and FDA approvals (e.g., venetoclax for leukemia)[1][3].
   • Asia-Pacific: Fastest-growing region (CAGR >7%), fueled by increasing cancer incidence and healthcare investments in China and India[1][16].

Challenges

• Toxicity Concerns: Anthracyclines (e.g., doxorubicin) face limitations due to cardiotoxicity[3].
• High Costs: Novel therapies like ADCs and PROTACs (proteolysis-targeting chimeras) require substantial R&D investments[6][15].
• Regulatory Hurdles: Stringent approval processes delay market entry, particularly in Europe and the U.S.[1].

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Patent Landscape

Key Innovations

1. Novel Inhibitors:
   • WO2020249483A1: Antibodies targeting ZIP6/ZIP10 proteins to block mitosis in melanoma and prostate cancer[4].
   • US11839609B1: Substituted tetrahydroisoquinolines for triple-negative breast cancer[5].
2. Combination Therapies:
   • US11224573B2: Co-delivery of mitotic kinase inhibitors (e.g., aurora kinase inhibitors) with immune checkpoint inhibitors (e.g., PD-1 blockers)[10].
3. Drug Repurposing:
   • Gemfibrozil (lipid-lowering agent) patented for Krabbe disease, highlighting crossover potential in mitosis-related disorders[7].

Emerging Trends

1. Targeted Protein Degradation:
   • PROTACs like DT2216 (BCL-XL degrader) show promise in overcoming resistance to venetoclax[2].
2. Nanotechnology:
   • Nanoformulations enhance bioavailability and reduce systemic toxicity (e.g., liposomal doxorubicin)[6].
3. Regional Patent Activity:
   • U.S. Dominance: Accounts for 50% of cancer-related patents, including key filings from Bristol-Myers Squibb and Pfizer[9].
   • China’s Rise: Rapid growth in patent filings, surpassing the EU in 2021[9].

Competitive Strategies

• Big Pharma: Companies like Novartis and Eli Lilly focus on kinase inhibitors (e.g., aurora kinase blockers) and ADCs[1][15].
• Academia-Industry Partnerships: Universities file 30% of patents, particularly in PROTACs and immunotherapy combinations[9][12].

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Future Outlook

• Personalized Medicine: Biomarker-driven therapies (e.g., HER2-targeted ADCs) will dominate new approvals[13].
• Global Expansion: Emerging markets in Latin America and Africa prioritize cost-effective generics and partnerships to improve access[1][3].
• Patent Cliffs: Expirations of blockbuster drugs (e.g., venetoclax post-2030) will spur biosimilar development[2][14].

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Key Takeaways

Factor	Detail
Market Growth	Driven by aging populations and precision oncology advancements.
Innovation Hotspots	PROTACs, ADCs, and combination therapies with immunotherapy.
Regional Leaders	U.S. leads in R&D; Asia-Pacific fastest-growing market.
Barriers	Toxicity, high costs, and regulatory complexity limit adoption.

The convergence of innovative drug designs, strategic patents, and expanding global healthcare access positions mitosis-inhibiting therapies as a cornerstone of modern oncology.

References

1. https://datahorizzonresearch.com/mitotic-inhibitors-market-6994
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC9942934/
3. https://straitsresearch.com/report/antitumor-antibiotics-market
4. https://patents.google.com/patent/WO2020249483A1/en
5. https://patents.google.com/patent/US11839609B1/en
6. https://pmc.ncbi.nlm.nih.gov/articles/PMC8487283/
7. https://drugrepocentral.scienceopen.com/hosted-document?doi=10.58647%2FDRUGREPO.24.1.0012
8. https://www.factmr.com/report/4350/anticancer-drugs-market
9. https://link.epo.org/web/publications/studies/en-patents-and-innovation-against-cancer-study.pdf
10. https://patents.google.com/patent/US11224573B2/en
11. https://www.globenewswire.com/news-release/2024/11/12/2979157/28124/en/Circulating-Tumor-Cells-Patent-Landscape-and-Forecast-2024-2032-The-U-S-Leads-with-Over-4-000-Patent-Filings-Driven-by-Robust-R-D-Infrastructure-and-Substantial-Investments-in-Canc.html
12. https://patents.google.com/patent/EP1989320A2/en
13. https://www.mdpi.com/1999-4923/16/2/221
14. https://ipwatchdog.com/2017/08/10/immunotherapy-patent-landscape-patent-claims-immunotherapeutic-inventions/id=86634/
15. https://researchoutput.ncku.edu.tw/en/publications/advances-in-aurora-kinase-inhibitor-patents
16. https://www.databridgemarketresearch.com/reports/global-mitotic-inhibitors-market