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Last Updated: May 24, 2025

PULMICORT RESPULES Drug Patent Profile


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

Pulmicort Respules is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in PULMICORT RESPULES is budesonide. There are twenty-two drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the budesonide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Pulmicort Respules

A generic version of PULMICORT RESPULES was approved as budesonide by TEVA PHARMS on November 18th, 2008.

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Drug patent expirations by year for PULMICORT RESPULES
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Recent Clinical Trials for PULMICORT RESPULES

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

SponsorPhase
Bond Avillion 2 Development LPPhase 1
Xiuyi ZhiPhase 4
Yale UniversityN/A

See all PULMICORT RESPULES clinical trials

Pharmacology for PULMICORT RESPULES
Paragraph IV (Patent) Challenges for PULMICORT RESPULES
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PULMICORT RESPULES Inhalation Suspension budesonide 1 mg/2 mL 020929 1 2010-05-28
PULMICORT RESPULES Inhalation Suspension budesonide 0.25 mg/2 mL and 0.5 mg/2 mL 020929 1 2005-09-15

US Patents and Regulatory Information for PULMICORT RESPULES

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-001 Aug 8, 2000 AN RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 AN RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-003 Aug 8, 2000 AN RX Yes Yes ⤷  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

Expired US Patents for PULMICORT RESPULES

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 6,899,099*PED ⤷  Try for Free
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-001 Aug 8, 2000 6,899,099*PED ⤷  Try for Free
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-001 Aug 8, 2000 4,787,536*PED ⤷  Try for Free
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 6,598,603*PED ⤷  Try for Free
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 4,787,536*PED ⤷  Try for Free
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-003 Aug 8, 2000 6,899,099*PED ⤷  Try for Free
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-001 Aug 8, 2000 7,524,834*PED ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for PULMICORT RESPULES

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Dr. Falk Pharma GmbH Jorveza budesonide EMEA/H/C/004655
Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).
Authorised no no yes 2018-01-08
Stada Arzneimittel AG Kinpeygo budesonide EMEA/H/C/005653
Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
Authorised no no yes 2022-07-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for PULMICORT RESPULES

See the table below for patents covering PULMICORT RESPULES around the world.

Country Patent Number Title Estimated Expiration
Israel 136086 PROCESS FOR PREPARATION OF STERILE GLUCOCORTICOSTEROIDS ⤷  Try for Free
Norway 861064 ⤷  Try for Free
Portugal 8571 ⤷  Try for Free
South Korea 100571075 ⤷  Try for Free
Denmark 111086 ⤷  Try for Free
South Africa 9810217 New composition of matter ⤷  Try for Free
Denmark 1032396 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PULMICORT RESPULES

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 SPC/GB21/029 United Kingdom ⤷  Try for Free PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
2435024 21C1020 France ⤷  Try for Free PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024 2190014-7 Sweden ⤷  Try for Free PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
2435024 LUC00208 Luxembourg ⤷  Try for Free PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
2435024 2021C/518 Belgium ⤷  Try for Free PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2435024 301102 Netherlands ⤷  Try for Free PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024 132021000000095 Italy ⤷  Try for Free PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for Pulmicort Respules

Introduction to Pulmicort Respules

Pulmicort Respules, a formulation of the corticosteroid budesonide, are a crucial component in the management of respiratory diseases, particularly asthma and chronic obstructive pulmonary disease (COPD). These respules are administered via nebulizers, providing a direct and effective method of delivering medication to the respiratory system.

Market Size and Growth

The global respules market, which includes Pulmicort Respules, has been valued at USD 2.31 billion in 2022 and is anticipated to grow at a compound annual growth rate (CAGR) of 5.22% through 2028[1].

Key Market Drivers

Rising Prevalence of Respiratory Diseases

The increasing prevalence of respiratory diseases such as asthma, COPD, and bronchitis is a significant driver for the respules market. These conditions, exacerbated by factors like urbanization, pollution, smoking, and lifestyle changes, have led to a substantial demand for effective respiratory medications like Pulmicort Respules[1].

Technological Advancements

Innovations in drug delivery systems, including portable nebulizers and smart inhalation devices, have improved patient compliance and treatment outcomes. These advancements have made respules more efficient and user-friendly, contributing to their growing popularity[1].

Aging Population

The aging global population is more prone to respiratory diseases, which boosts the demand for respules. As the population ages, the need for medications like Pulmicort Respules increases, driving market growth[1].

Increasing Awareness and Early Diagnosis

Growing awareness of preventive healthcare measures has led to early diagnosis and treatment of respiratory disorders. This trend fuels the demand for respules as a preferred mode of drug delivery, enhancing market growth[1].

Regional Insights

North America

North America, particularly the United States and Canada, holds the largest market share for respules. The region has witnessed a significant increase in respiratory diseases due to factors like air pollution, changing lifestyles, and an aging population. The advanced healthcare infrastructure in North America supports the research, development, and distribution of respiratory medications, including Pulmicort Respules[1].

Competitive Landscape

Pulmicort Respules are part of the product portfolio of major pharmaceutical companies such as AstraZeneca. The global respules market is competitive, with other key players including Cipla Limited, Sandoz International GmbH, Lupin Limited, and Biochemix Healthcare Private Limited[1].

Partnerships and Collaborations

In February 2022, Glenmark Pharmaceuticals partnered with AstraZeneca to commercialize Pulmicort Respules in Colombia. Such collaborations enhance the market reach and availability of Pulmicort Respules, contributing to the overall growth of the respules market[4].

Financial Performance

Revenue Growth

The respules market, driven by the growing demand for medications like Pulmicort Respules, is expected to see significant revenue growth. From a market size of USD 2.31 billion in 2022, the market is projected to grow with a CAGR of 5.22% through 2028[1].

Segmental Growth

The budesonide segment, which includes Pulmicort Respules, is identified as the fastest-growing segment within the respules market. This growth is attributed to the effectiveness of budesonide in managing respiratory conditions and the increasing adoption of respules as a preferred treatment option[1].

Market Trends and Opportunities

Advancements in Drug Formulations

Advancements in drug formulations, including biologic therapies and smart inhalers, are expected to drive the growth of the respules market. These innovations improve patient compliance and treatment outcomes, making respules more appealing to both patients and healthcare providers[4].

Personalized Medicine Approaches

The trend towards personalized medicine is another significant driver. Pharmacies can customize medication regimens to suit individual patient needs, enhancing the effectiveness of respules like Pulmicort Respules in managing respiratory conditions[1].

Telemedicine and Remote Care

The integration of telemedicine and remote care is expected to further boost the market. These services improve access to healthcare, allowing for better management of respiratory diseases and increased use of respules[4].

Challenges and Regulatory Environment

Regulatory Challenges

Manufacturers of respules, including Pulmicort Respules, must navigate regulatory challenges. Compliance with regulatory standards is crucial for market expansion and ensuring the quality and safety of these medications[1].

Environmental Factors

Environmental factors such as air pollution and allergens continue to contribute to the prevalence of respiratory conditions. While these factors drive the demand for respules, they also highlight the need for sustainable manufacturing practices and patient-centric solutions[1].

Recent Developments

  • Approval and Commercialization: Recent partnerships, such as the one between Glenmark Pharmaceuticals and AstraZeneca, have expanded the commercialization of Pulmicort Respules in various regions, enhancing market access and growth[4].

  • Clinical Efficacy: Clinical studies have demonstrated the efficacy of Pulmicort Respules in managing respiratory diseases. For instance, budesonide respules have shown significant benefits in reducing symptoms and improving quality of life for patients with asthma and COPD[1].

Key Takeaways

  • The global respules market, including Pulmicort Respules, is driven by the rising prevalence of respiratory diseases and technological advancements in drug delivery.
  • North America is the largest market for respules due to its advanced healthcare infrastructure and high prevalence of respiratory diseases.
  • Partnerships and collaborations among pharmaceutical companies are crucial for expanding market reach and enhancing product availability.
  • The market is expected to grow with a CAGR of 5.22% through 2028, driven by advancements in drug formulations and personalized medicine approaches.

FAQs

Q: What is the current market size of the global respules market? A: The global respules market was valued at USD 2.31 billion in 2022[1].

Q: What is the expected CAGR for the global respules market through 2028? A: The global respules market is anticipated to grow at a CAGR of 5.22% through 2028[1].

Q: Which region holds the largest market share for respules? A: North America holds the largest market share for respules due to its advanced healthcare infrastructure and high prevalence of respiratory diseases[1].

Q: What are the key drivers for the growth of the respules market? A: The key drivers include the rising prevalence of respiratory diseases, technological advancements in drug delivery, and an aging global population[1].

Q: Which segment is the fastest-growing within the respules market? A: The budesonide segment, which includes Pulmicort Respules, is identified as the fastest-growing segment within the respules market[1].

Cited Sources

  1. TechSci Research: "Respules Market By Size, Share and Forecast 2028"
  2. AstraZeneca: "Full year and Q4 2021 results - AstraZeneca"
  3. BioSpace: "U.S. Asthma Drugs Market Size to Surpass USD 14.75 Bn by 2033"
  4. The Business Research Company: "Global Respules Market Report 2024"
Last updated: 2024-12-22

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