Drugs in MeSH Category Cytochrome P-450 Enzyme Inhibitors

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208327-002	Dec 23, 2020	AB	RX	No	No
Dr Reddys	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208416-002	Sep 1, 2023	AB	RX	No	No
Mylan	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208446-002	Dec 14, 2020	AB	RX	No	No
Mylan	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208446-001	Oct 31, 2018	AB	RX	No	No
Rising	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208371-001	Feb 25, 2019	AB	RX	No	No
Sun Pharm	YONSA	abiraterone acetate	TABLET;ORAL	210308-001	May 22, 2018		RX	Yes	Yes	9,889,144		Y

Cytochrome P-450 Enzyme Inhibitors Market Analysis and Financial Projection

The global market for cytochrome P-450 enzyme inhibitors reflects significant growth driven by therapeutic applications and pharmaceutical innovation, while the patent landscape reveals strategic protections and emerging competition. Below, we analyze these dynamics through market segmentation, regional trends, and intellectual property developments.

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Market Dynamics

Growth Drivers and Challenges

• The cytochrome inhibitors market is projected to grow at a steady CAGR between 2024–2031, fueled by rising R&D investments and demand for treatments targeting drug-drug interactions[1][6].
• Key growth factors include:
  • Expanding applications in oncology, infectious diseases (e.g., HCV, HIV), and cardiovascular therapies[1][13].
  • Increasing healthcare expenditure in emerging markets like Asia-Pacific, where technological advancements and awareness programs are accelerating adoption[6][9].
• Restraints: Limited understanding of drug interactions and adverse effects hampers market penetration[1][11].

Market Segmentation

• By Drug Class: Amiodarone, clarithromycin, and grapefruit juice dominate due to their CYP3A4 inhibition properties[1][6].
• By Enzyme Target: CYP3A4 inhibitors account for the largest share, driven by their role in metabolizing ~50% of clinical drugs[3][14].
• By Region:
  • North America leads with >40% market share, supported by advanced healthcare infrastructure[1][6].
  • Asia-Pacific is the fastest-growing region, projected to surpass $XX billion by 2031 due to generics production and regulatory reforms[6][9].

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Patent Landscape

Key Trends and Innovations

• Compound Patents: Broad claims covering molecular structures (e.g., voxilaprevir’s Markush formula in WO 2014/008285) remain critical for blocking generics[2][13].
• Process and Formulation Patents: Non-constraining patents for crystalline forms (e.g., voxilaprevir polymorphs) allow generics to bypass claims with alternative manufacturing methods[2][10].
• Therapeutic Focus:
  • Antivirals: Patents for HCV protease inhibitors (e.g., Gilead’s voxilaprevir) and HIV therapies (e.g., ritonavir)[2][7].
  • Oncology: CYP17/19 inhibitors for prostate/breast cancer treatments[13][16].

Geographical and Competitive Insights

• Top Filers: Universities and pharma giants (e.g., Gilead, Tibotec) dominate filings, with China and the U.S. as primary jurisdictions[7][9][13].
• Strategic Shifts: Single-country patent filings surged post-2012, particularly in China, reflecting localized R&D strategies[9].

Notable Patents

Patent Focus	Example	Significance
CYP3A4 Inhibitors	US7169763B2 (nordihydroguaiaretic acid)	Enhances drug bioavailability[16]
HCV Therapeutics	WO2014/008285 (voxilaprevir)	Blocks generic entry via structural claims[2]
Antiretroviral Combos	CN patents for ritonavir combinations	Addresses HIV drug resistance[7]

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Regulatory and Industry Impact

• Drug-Drug Interaction (DDI) Testing: FDA/EMA mandates require CYP450 inhibition profiling during drug development, increasing demand for in vitro assays[14].
• Generic Entry Barriers: Expiry of blockbuster drug patents (e.g., simvastatin) has intensified litigation around CYP-mediated metabolism[4][16].

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Key Takeaways
The cytochrome P-450 inhibitor market thrives on therapeutic diversification and geographic expansion, while patent strategies pivot toward structural claims and process innovations. Emerging markets like Asia-Pacific will likely dictate future growth, though regulatory hurdles and generic competition persist.

References

1. https://www.openpr.com/news/3706174/the-future-of-cytochrome-inhibitors-market-share-analysis
2. https://unitaid.org/uploads/UTD17004_04_Voxilaprevir_v04.pdf
3. https://meshb.nlm.nih.gov/record/ui?ui=D065692
4. https://www.ftc.gov/sites/default/files/documents/reports/generic-drug-industry-dynamics/industrydynamicsreiffenwp_0.pdf
5. https://pubs.acs.org/doi/10.1021/acs.jmedchem.7b00772
6. https://www.databridgemarketresearch.com/reports/global-cytochrome-inhibitors-market
7. https://www.wipo.int/edocs/plrdocs/en/i_mak_hiv_drug_patents_in_china_tahir_amin_may_2010.pdf
8. https://www.ncbi.nlm.nih.gov/mesh/68065607
9. https://www.scielo.br/j/mioc/a/yV6twWPxYvpC6XcVdt4C8Sj/?format=pdf&lang=en
10. https://patents.google.com/patent/WO2009105774A2/en
11. https://pmc.ncbi.nlm.nih.gov/articles/PMC1312247/
12. https://patents.justia.com/patent/6492132
13. https://pubmed.ncbi.nlm.nih.gov/24660660/
14. https://www.criver.com/products-services/lab-sciences/dmpk/cytochrome-p450-interaction-assays
15. https://journals.sagepub.com/doi/10.1177/1535759720928269
16. https://patents.google.com/patent/US7169763B2/en
17. https://meshb-prev.nlm.nih.gov/record/ui?ui=D065692