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Last Updated: December 22, 2024

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE Drug Patent Profile


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Which patents cover Dutasteride And Tamsulosin Hydrochloride, and what generic alternatives are available?

Dutasteride And Tamsulosin Hydrochloride is a drug marketed by Actavis Labs Fl Inc, Aurobindo Pharma, Endo Operations, and Zydus Pharms. and is included in four NDAs.

The generic ingredient in DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE is dutasteride; tamsulosin hydrochloride. There are eighteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dutasteride And Tamsulosin Hydrochloride

A generic version of DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE was approved as dutasteride; tamsulosin hydrochloride by ENDO OPERATIONS on February 26th, 2014.

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Summary for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Drug patent expirations by year for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Recent Clinical Trials for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

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SponsorPhase
Beth Israel Deaconess Medical CenterN/A
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)N/A
Ministry of Health, FrancePhase 3

See all DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE clinical trials

Pharmacology for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

US Patents and Regulatory Information for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Fl Inc DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 202975-001 Nov 20, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 207769-001 May 24, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 213300-001 Jul 18, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Endo Operations DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 202509-001 Feb 26, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dutasteride and Tamsulosin Hydrochloride

Introduction to Dutasteride and Tamsulosin Hydrochloride

Dutasteride and tamsulosin hydrochloride is a combination therapy used to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Dutasteride is a 5-alpha reductase inhibitor that reduces the size of the prostate, while tamsulosin is an alpha-blocker that relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Market Growth and Forecast

The global market for BPH treatments, including dutasteride and tamsulosin, is experiencing significant growth. The BPH treatment market is projected to grow from $10.8 billion in 2021 to $14.1 billion by 2026, driven by an increasing incidence of BPH and the adoption of generic versions of these medications[3].

Sales and Revenue

Historical sales data indicate that the combination therapy of dutasteride and tamsulosin has shown strong growth trends. The sales of this combination therapy have been analyzed globally and by country, with significant revenues reported in the US, Germany, France, Italy, Spain, UK, Japan, Brazil, Russia, India, China, Canada, and Australia[1].

Sales Forecast

The sales forecast for dutasteride and tamsulosin combination therapy is positive, with continued growth expected until 2026 and beyond. The global tamsulosin market alone is expected to reach USD 1.8 billion by 2032, exhibiting a CAGR of 6.3%[4].

Cost-Effectiveness and Economic Impact

Cost-Effectiveness Analysis

Studies have shown that the combination therapy of dutasteride and tamsulosin is cost-effective compared to monotherapies. In Canada, for instance, the combination therapy was found to be more cost-effective than either dutasteride or tamsulosin alone, with a high probability of being cost-effective at a willingness to pay of CAN$50,000 per quality-adjusted life year (QALY)[2].

Economic Benefits

The economic benefits of this combination therapy are significant. It offers improved patient outcomes at a lower cost compared to monotherapies, making it a favorable option for healthcare systems. The incremental cost-effectiveness ratio was found to be CAN$25,437 per QALY gained, indicating a strong economic case for its use[2].

Market Segmentation and Trends

Drug Classes

The BPH treatment market is segmented into several drug classes, including alpha-blockers (such as tamsulosin) and 5-alpha reductase inhibitors (such as dutasteride). The availability of generics post-patent expiry has supported market growth for these drug classes. For example, the generic version of tamsulosin can cost as low as USD 8 per month, significantly lower than the branded version[3].

Regional Markets

The market for dutasteride and tamsulosin is analyzed by region, with key markets including North America, Europe, Japan, BRIC countries, and Australia. Each region has its own growth trends and sales forecasts, influenced by local healthcare policies, patient demographics, and market competition[1].

Competitive Landscape

Market Players

The market for BPH treatments is competitive, with several companies marketing dutasteride and tamsulosin under various brand names. The expiration of patents for branded products like Avodart and Jalyn has paved the way for generic manufacturers, increasing competition and driving market growth[3].

Generic Versions

The availability of generic versions of dutasteride and tamsulosin has significantly impacted the market. Generic versions are cheaper and have increased access to these medications, leading to higher sales volumes despite lower revenue per unit[3].

Pricing Analysis

Unit Price by Countries

The unit price of dutasteride and tamsulosin varies by country, influenced by local pricing regulations, market competition, and the availability of generic versions. The report by ResearchAndMarkets provides detailed pricing analysis and benchmarks for these medications across various countries[1].

Price Trends

The price trends for dutasteride and tamsulosin are influenced by the transition from branded to generic versions. While the lower prices of generics may reduce overall revenue in the short term, they increase access and potentially lead to higher sales volumes over time[3].

Regulatory and Safety Considerations

Regulatory Approval

The combination therapy of dutasteride and tamsulosin has been approved for the treatment of symptomatic BPH in men with an enlarged prostate. Regulatory approvals were based on clinical trials demonstrating the bioequivalence and efficacy of the combination therapy compared to monotherapies[5].

Safety Profile

The safety profile of the combination therapy has been evaluated, with a favorable risk-benefit profile established. However, there have been observations of a numerical imbalance in the incidence of cardiac failure compared to monotherapies, which is being monitored post-marketing[5].

Key Takeaways

  • Market Growth: The BPH treatment market, including dutasteride and tamsulosin, is expected to grow significantly from $10.8 billion in 2021 to $14.1 billion by 2026.
  • Cost-Effectiveness: The combination therapy is cost-effective compared to monotherapies, offering improved patient outcomes at a lower cost.
  • Market Segmentation: The market is segmented by drug class and region, with generics playing a crucial role in market growth.
  • Pricing Trends: The transition to generic versions has lowered prices, increasing access and potentially leading to higher sales volumes.
  • Regulatory and Safety: The combination therapy has a favorable risk-benefit profile, though cardiac failure is being monitored post-marketing.

FAQs

What is the projected market size for the BPH treatment market by 2026?

The global BPH treatment market is forecasted to grow from $10.8 billion in 2021 to $14.1 billion by 2026[3].

How does the combination therapy of dutasteride and tamsulosin compare to monotherapies in terms of cost-effectiveness?

The combination therapy is more cost-effective than either dutasteride or tamsulosin alone, with a high probability of being cost-effective at a willingness to pay of CAN$50,000 per QALY[2].

What is the impact of generic versions on the market for dutasteride and tamsulosin?

Generic versions have increased access to these medications, leading to higher sales volumes despite lower revenue per unit. The price of a generic version can be as low as USD 8 per month, compared to nearly USD 100 per month for branded products[3].

Which regions are key markets for dutasteride and tamsulosin?

Key markets include North America, Europe, Japan, BRIC countries, and Australia, each with its own growth trends and sales forecasts[1].

What are the safety considerations for the combination therapy of dutasteride and tamsulosin?

The combination therapy has a favorable risk-benefit profile, but there have been observations of a numerical imbalance in the incidence of cardiac failure compared to monotherapies, which is being monitored post-marketing[5].

How does the regulatory approval impact the market for dutasteride and tamsulosin?

Regulatory approvals have been based on clinical trials demonstrating the bioequivalence and efficacy of the combination therapy, which has supported its market presence and growth[5].

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