PULMICORT RESPULES Drug Patent Profile

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 18^th, 2008.

Summary for PULMICORT RESPULES

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	13
Patent Applications:	5,828
Drug Prices:	Drug price information for PULMICORT RESPULES
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PULMICORT RESPULES
What excipients (inactive ingredients) are in PULMICORT RESPULES?	PULMICORT RESPULES excipients list
DailyMed Link:	PULMICORT RESPULES at DailyMed

See drug prices for PULMICORT RESPULES

Recent Clinical Trials for PULMICORT RESPULES

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

Sponsor	Phase
Bond Avillion 2 Development LP	Phase 1
Xiuyi Zhi	Phase 4
Yale University	N/A

See all PULMICORT RESPULES clinical trials

Pharmacology for PULMICORT RESPULES

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-002	Aug 8, 2000	AN	RX	Yes	No
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-003	Aug 8, 2000	AN	RX	Yes	Yes

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
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-001	Aug 8, 2000	6,899,099*PED
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-001	Aug 8, 2000	4,787,536*PED
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-002	Aug 8, 2000	6,598,603*PED
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-002	Aug 8, 2000	4,787,536*PED
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-003	Aug 8, 2000	6,899,099*PED
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-001	Aug 8, 2000	7,524,834*PED

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

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
Norway	861064
Portugal	8571
South Korea	100571075
Denmark	111086
South Africa	9810217	New composition of matter
Denmark	1032396

Supplementary Protection Certificates for PULMICORT RESPULES

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	SPC/GB21/029	United Kingdom		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		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		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		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		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		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		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

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