Cytochrome P450 2D6 Inhibitor Drug Class List

Drugs in Drug Class: Cytochrome P450 2D6 Inhibitor

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208453-001	Oct 31, 2018	AB	RX	No	No
Dr Reddys	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208416-001	May 18, 2020	AB	RX	No	No
Dr Reddys	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208416-002	Sep 1, 2023	AB	RX	No	No
Hikma	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208339-001	Oct 31, 2018	AB	RX	No	No
Mylan	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208446-002	Dec 14, 2020	AB	RX	No	No
Qilu	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	212462-001	Sep 27, 2019	AB	RX	No	No

Cytochrome P450 2D6 Inhibitor Market Analysis and Financial Projection

The global market for Cytochrome P450 2D6 (CYP2D6) inhibitors is experiencing significant growth, driven by advancements in pharmacogenomics and personalized medicine. These inhibitors, which modulate the activity of a critical drug-metabolizing enzyme, are increasingly used to optimize therapeutic outcomes and minimize adverse effects. Below is a detailed analysis of market dynamics and patent trends shaping this drug class.

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Market Dynamics

Growth Drivers

• Pharmacogenomic Integration: CYP2D6 metabolizes 25% of clinically used drugs, including antidepressants and antipsychotics[3][8]. Genetic polymorphisms in CYP2D6 influence enzyme activity, necessitating personalized dosing strategies. This has fueled demand for inhibitors that manage metabolic variability[8][10].
• R&D Investments: Over $1 billion in R&D is dedicated to CYP2D6-related therapies, with 7 approved drugs and 368 clinical trials underway as of 2023[2][6]. Axsome Therapeutics and GSK lead development for CNS disorders[2].
• Drug-Drug Interaction Management: FDA classifications (strong/moderate/weak inhibitors)[6] guide clinical use, particularly for narrow-therapeutic-index drugs. Emerging markets in Asia-Pacific are adopting these guidelines, contributing to a projected CAGR of 8–12% through 2028[1][9].

Market Segmentation

Category	Key Segments
Drugs	Amiodarone, fluoxetine, metronidazole, grapefruit juice[1]
Enzymes Targeted	CYP2C9, CYP3A4, CYP2D6 (accounts for 25% of drug metabolism)[1][3]
End-Users	Hospitals (60% market share), specialty clinics, home healthcare[1]
Distribution	Hospital pharmacies, online platforms (25% growth post-pandemic)[1][5]

Geographical Insights: North America dominates (45% market share) due to advanced healthcare infrastructure, followed by Europe. Asia-Pacific is the fastest-growing region, driven by increased healthcare spending[1][3].

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Patent Landscape Analysis

Key Patent Trends

1. Method-of-Treatment Patents:

   • Dosing Optimization: Patents like US 8,586,610 (Vanda Pharmaceuticals) protect methods for adjusting iloperidone doses based on CYP2D6 genotype to prevent QT prolongation[4][12]. This precedent confirms patent eligibility for genotype-specific dosing regimens[12].
   • Combination Therapies: WO2000059486A2 covers CYP2D6 inhibitors paired with drugs metabolized by the enzyme (e.g., bupropion/dextromethorphan combinations)[15]. Antecip Bioventures recently secured patents for CYP2D6-adjusted doses in renal/hepatic impairment[14].

2. Drug Repurposing Strategies:

   • Companies extend patent life by identifying new indications. For example, CYP2D6 inhibitors are being repurposed for Alzheimer’s and seasonal affective disorder[2][5].

3. AI-Driven Innovations:

   • Machine learning models predict CYP2D6 interactions with herbal compounds, enabling novel inhibitor discovery[10]. Patents in this space focus on computational methods for metabolic pathway analysis[5].

Legal Precedents

• Vanda v. West-Ward (2018): Upheld patents linking CYP2D6 genotypes to dosing protocols, distinguishing them from unpatentable natural laws[4][12].
• Genentech v. Sandoz (2022): Validated patents managing drug-drug interactions (e.g., CYP1A2 inhibitors with pirfenidone), emphasizing clinical utility over mere observational claims[9].

Competitive Landscape

• Top Assignees: Pfizer, Teva, and Sun Pharma dominate small-molecule inhibitors[1][7]. Abbott Laboratories leads in ritonavir-related formulations (194 patents)[7].
• Emerging Players: Startups like Antecip Bioventures focus on niche populations (e.g., CYP2D6 poor metabolizers) using combination therapies[14].

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Future Outlook

• Regulatory Shifts: The FDA and EMA now mandate pharmacogenetic data for CYP2D6 substrates, accelerating companion diagnostic development[8][9].
• Public-Private Partnerships: Collaborations between pharma and AI firms aim to identify 50+ novel CYP2D6 inhibitors by 2030[5][10].
• Biosimilar Competition: Patent expirations post-2028 (e.g., iloperidone) will expand generics, reducing costs by 30–40%[1][5].

Highlight: "The future of CYP2D6 inhibitor development lies in precision dosing algorithms that integrate genomic data, minimizing trial-and-error prescribing." – Frontiers in Pharmacology[8].

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Key Takeaways

1. The CYP2D6 inhibitor market is driven by genetic testing adoption and drug interaction management.
2. Patents increasingly protect dosing algorithms and combination therapies, with litigation favoring clinically actionable claims.
3. AI and repurposing strategies are critical for sustaining innovation in a competitive landscape.

References

1. https://www.databridgemarketresearch.com/reports/global-cytochrome-inhibitors-market
2. https://synapse.patsnap.com/blog/advances-in-clinical-research-on-cyp2d6-inhibitor
3. https://pmc.ncbi.nlm.nih.gov/articles/PMC1874287/
4. https://jmin.com/patent-eligibility-of-diagnostic-gene-signature-method-claims/
5. https://patentpc.com/blog/patent-implications-of-drug-repurposing
6. https://pmc.ncbi.nlm.nih.gov/articles/PMC7292748/
7. https://www.keionline.org/21711
8. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.650750/full
9. https://www.jdsupra.com/legalnews/genentech-inc-v-sandoz-inc-7421316/
10. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2020.00683/full
11. https://patents.google.com/patent/US20030144220A1/fr
12. https://ipwatchdog.com/2018/06/19/patent-eligibility-determinations-life-sciences-patent-cases/id=98352/
13. https://patents.justia.com/patent/10272076
14. https://patents.justia.com/assignee/antecip-bioventures-ii-llc
15. https://patents.google.com/patent/WO2000059486A2/en