Drugs in ATC Class C08DB

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Up to C08 - CALCIUM CHANNEL BLOCKERS

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Drugs in ATC Class: C08DB - Benzothiazepine derivatives

Tradename	Generic Name
CARDIZEM CD	diltiazem hydrochloride
CARDIZEM SR	diltiazem hydrochloride
CARTIA XT	diltiazem hydrochloride
DILACOR XR	diltiazem hydrochloride
DILT-CD	diltiazem hydrochloride

C08DB Market Analysis and Financial Projection

The market dynamics and patent landscape for ATC class C08DB (benzothiazepine derivatives) reflect a niche but evolving segment within cardiovascular therapeutics, driven by both established generics and novel research. Here’s a detailed analysis:

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Market Dynamics

Current Landscape

• Primary Drug: Diltiazem is the key benzothiazepine derivative under C08DB, classified as a calcium channel blocker for hypertension and angina[1][5]. The global diltiazem market was valued at $1.02 billion in 2022, projected to reach $1.5 billion by 2030 (CAGR: 5.0%)[14].
• Growth Drivers:
  • Rising cardiovascular disease burden, with hypertension affecting ~1.3 billion adults worldwide[14].
  • Aging populations in developed regions and improving healthcare access in Asia-Pacific[10][14].
  • Generic dominance post-patent expirations (e.g., Cardizem LA patents expired between 2013–2021)[9][13].

Regional Insights

• North America/Europe: Hold major market shares due to high hypertension prevalence and established generic competition[14].
• Asia-Pacific: Fastest-growing region, driven by cost-effective manufacturing (e.g., India, China) and expanding healthcare infrastructure[10].

Challenges

• Price Stability: Collusion risks in the generic market (e.g., alleged cartel activity impacting drug pricing)[8].
• Therapeutic Competition: Newer antihypertensives (e.g., ARBs, ACE inhibitors) and non-pharmacological interventions.

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Patent Landscape

Expired Patents

• Diltiazem Formulations:
  • Cardizem LA: Patents on extended-release formulations (e.g., US5529791) expired by 2013[9].
  • Diltiazem Hydrochloride: Key patents expired in 2013, leading to widespread generic adoption[13].

Recent Innovations

• Novel Derivatives:
  • Ipsen SA and Albireo Pharma secured patents (2024) for 1,5-benzothiazepine and 1,2,5-benzothiadiazepine derivatives targeting metabolic, gastrointestinal, and liver diseases[4][16]. These compounds modulate bile acids, expanding therapeutic applications beyond cardiovascular uses[4][12].
  • Structural modifications (e.g., acyl group substitutions) enhance selectivity and reduce side effects[2][12].

Strategic Trends

• Diversification: Companies are repurposing benzothiazepines for metabolic disorders (e.g., diabetes, NAFLD)[4][16].
• Combination Therapies: Patents for fixed-dose combinations (e.g., C08G class with diuretics)[5] aim to improve adherence.

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Future Outlook

• Generics: Continued market saturation, with diltiazem generics dominating[9][13].
• R&D Opportunities:
  • New Indications: Anti-inflammatory, antiviral, and anticancer applications of benzothiazepines[12].
  • Targeted Delivery: Chronotherapeutic formulations (e.g., US7108866)[9] to optimize dosing schedules.

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Key Takeaways

1. C08DB remains anchored by diltiazem, but innovation focuses on derivatives for non-cardiovascular diseases.
2. Generics dominate post-2013, but price stability is vulnerable to market practices[8][14].
3. Asia-Pacific’s cost advantages position it as a future generic production hub[10][14].

For stakeholders, balancing generic competitiveness with novel R&D investments will be critical in this evolving landscape.

References

1. https://atcddd.fhi.no/atc_ddd_index/?code=C08DB01
2. https://patents.google.com/patent/WO1992012148A1/en
3. https://www.skyquestt.com/report/benzene-and-its-derivatives-market
4. https://www.pharmaceutical-technology.com/data-insights/ipsen-gets-grant-for-treatment-of-diseases-with-specific-benzothiazepine-and-benzothiadiazepine-derivatives/
5. https://en.wikipedia.org/wiki/ATC_code_C08
6. https://vvkt.lrv.lt/media/viesa/saugykla/2023/9/nvNsI8S7K9U.pdf
7. https://www.mdpi.com/1660-4601/18/17/9216
8. https://www.econstor.eu/bitstream/10419/260480/1/qed-wp-1474.pdf
9. https://pharsight.greyb.com/drug/cardizem-la-patent-expiration
10. https://www.coherentmarketinsights.com/market-insight/benzodiazepine-drugs-market-5001
11. http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1392&lang=en
12. https://pmc.ncbi.nlm.nih.gov/articles/PMC9957176/
13. https://pharsight.greyb.com/drug/diltiazem-hydrochloride-patent-expiration
14. https://www.verifiedmarketreports.com/product/diltiazem-market/
15. https://pubchem.ncbi.nlm.nih.gov/compound/39186
16. https://www.pharmaceutical-technology.com/data-insights/albireo-pharma-gets-grant-for-treatment-of-diseases-with-specific-benzothiazepine-and-benzothiadiazepine-derivatives/
17. https://www.openpr.com/news/3924616/diltiazem-hydrochloride-injection-market-2025-growth-trends