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Last Updated: March 14, 2025

BRICANYL Drug Patent Profile


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Which patents cover Bricanyl, and when can generic versions of Bricanyl launch?

Bricanyl is a drug marketed by Sanofi Aventis Us and is included in three NDAs.

The generic ingredient in BRICANYL is terbutaline sulfate. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Bricanyl

A generic version of BRICANYL was approved as terbutaline sulfate by IMPAX LABS on June 26th, 2001.

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Summary for BRICANYL
Drug patent expirations by year for BRICANYL
Recent Clinical Trials for BRICANYL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of MonastirPhase 1
Yaakov BeilinPhase 2/Phase 3
University of MonastirPhase 3

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US Patents and Regulatory Information for BRICANYL

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Sanofi Aventis Us BRICANYL terbutaline sulfate INJECTABLE;INJECTION 017466-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sanofi Aventis Us BRICANYL terbutaline sulfate TABLET;ORAL 017618-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sanofi Aventis Us BRICANYL terbutaline sulfate AEROSOL, METERED;INHALATION 018000-001 Mar 19, 1985 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Expired US Patents for BRICANYL

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Sanofi Aventis Us BRICANYL terbutaline sulfate AEROSOL, METERED;INHALATION 018000-001 Mar 19, 1985 3,937,838 ⤷  Try for Free
Sanofi Aventis Us BRICANYL terbutaline sulfate TABLET;ORAL 017618-002 Approved Prior to Jan 1, 1982 4,011,258 ⤷  Try for Free
Sanofi Aventis Us BRICANYL terbutaline sulfate TABLET;ORAL 017618-001 Approved Prior to Jan 1, 1982 4,011,258 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for BRICANYL

Introduction to BRICANYL

BRICANYL, also known as terbutaline sulfate, is a bronchodilator used primarily for the treatment of asthma and other chronic respiratory conditions. It works by stimulating the β2-adrenergic receptors in bronchial smooth muscle, leading to relaxation of muscle fibers and an increase in pulmonary function[4].

Market Context: Inhalable Drugs

The inhalable drugs market, which includes BRICANYL, is experiencing significant growth driven by the increasing prevalence of chronic respiratory diseases such as asthma, COPD, and occupational lung diseases. The global inhalable drugs market is estimated to reach USD 88.4 billion by 2037, growing at a CAGR of 7.2% from 2025 to 2037[1].

Respiratory Diseases Segment

The respiratory diseases segment, where BRICANYL is categorized, is forecasted to account for 76.5% of the global inhalable drugs market share through 2037. This dominance is due to the rising cases of respiratory disorders worldwide, exacerbated by factors such as air pollution, tobacco and alcohol consumption, and allergic chemicals[1].

Regional Market Performance

North America

In North America, particularly in the U.S. and Canada, the market for inhalable drugs is robust due to advanced healthcare infrastructure and significant investments in research and development. The U.S. is a leading market for BRICANYL, with around 4.6% of adults diagnosed with emphysema, COPD, or chronic bronchitis in 2022, according to the Centers for Disease Control and Prevention[1].

Asia Pacific

The Asia Pacific region, including countries like China and India, is also witnessing rapid growth. In India, the expansion of pharmaceutical companies and the introduction of generic inhalable drugs have made treatments more affordable and accessible. China's severe air quality issues and rapidly expanding aging population are additional factors driving the demand for inhalable medications like BRICANYL[1].

Competitive Landscape

BRICANYL competes in a market dominated by several key players, including AstraZeneca, which markets terbutaline sulfate under the brand name Bricanyl. These companies are investing heavily in research and development to enhance drug delivery efficiency and patient compliance. Strategic partnerships, collaborations with research organizations, and regional expansions are common strategies employed by these players to maintain market share[1].

Financial Implications of Pharmaceutical R&D

The development and marketing of drugs like BRICANYL involve substantial financial investments. The average cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline of 10 to 15 years. The probability of success for a drug candidate entering clinical trials is only around 10%, which highlights the significant risks involved[3].

Revenue and Profitability

For established drugs like BRICANYL, revenue streams are substantial but can be affected by factors such as patent exclusivity and the emergence of generic or biosimilar competitors. For instance, AstraZeneca's financial reports show that while their respiratory and immunology segment, which includes BRICANYL, saw sales growth of 13% in 2021, the overall profitability can be impacted by shorter exclusivity periods and increasing regulatory costs[2].

Impact of Generic and Biosimilar Competitors

The introduction of generic or biosimilar versions of BRICANYL can significantly reduce sales for the original brand-name drug. This is a common challenge in the pharmaceutical industry, where shorter exclusivity periods driven by patent challenges can lead to a rapid decline in sales and profitability[3].

Public Health and Accessibility

Despite the financial challenges, the demand for inhalable drugs like BRICANYL remains high due to their effectiveness in treating chronic respiratory conditions. Public health initiatives, such as awareness campaigns and government investments in lung health research, further support the market growth. For example, the Government of Canada invested USD 19.3 million in 2024 to support research teams analyzing threats to lung health[1].

Future Outlook

The future outlook for BRICANYL and similar inhalable drugs is promising, driven by the escalating global burden of chronic respiratory diseases. As pharmaceutical companies continue to innovate in drug formulations and expand into emerging markets, the market for BRICANYL is expected to grow. However, managing the financial risks associated with R&D and maintaining profitability in the face of generic competition will remain key challenges.

Key Takeaways

  • The inhalable drugs market, including BRICANYL, is projected to grow significantly due to rising chronic respiratory diseases.
  • North America and the Asia Pacific region are key markets driven by advanced healthcare infrastructure and growing demand.
  • Financial investments in R&D are substantial, with high risks but potential for significant returns.
  • Generic and biosimilar competitors pose a significant threat to brand-name drug sales.
  • Public health initiatives and government investments support market growth.

FAQs

What is BRICANYL used for?

BRICANYL, or terbutaline sulfate, is used primarily for the treatment of asthma and other chronic respiratory conditions by stimulating the β2-adrenergic receptors in bronchial smooth muscle.

How is the market for inhalable drugs expected to grow?

The global inhalable drugs market is estimated to reach USD 88.4 billion by 2037, growing at a CAGR of 7.2% from 2025 to 2037.

What are the main factors driving the demand for BRICANYL?

The rising prevalence of chronic respiratory diseases, air pollution, tobacco and alcohol consumption, and allergic chemicals are key factors driving the demand for BRICANYL.

How does the introduction of generic or biosimilar competitors affect BRICANYL sales?

The introduction of generic or biosimilar competitors can significantly reduce sales for the original brand-name drug like BRICANYL due to shorter exclusivity periods and increased competition.

What are the financial implications of developing and marketing a drug like BRICANYL?

The development and marketing of a drug like BRICANYL involve substantial financial investments, with an average cost of $2.6 billion and a development timeline of 10 to 15 years, along with a high risk of failure.

Sources:

  1. Research Nester, "Inhalable Drugs Market Size & Share, Growth Report 2037"
  2. AstraZeneca, "2021 Annual Report"
  3. DrugBank Blog, "Investment Trends in Pharmaceutical Research"
  4. Health Canada, "PRODUCT MONOGRAPH BRICANYL TURBUHALER"

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