PULMICORT FLEXHALER Drug Patent Profile

When do Pulmicort Flexhaler patents expire, and what generic alternatives are available?

Pulmicort Flexhaler is a drug marketed by Cheplapharm and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pulmicort Flexhaler

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

Summary for PULMICORT FLEXHALER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	6
Patent Applications:	5,828
Drug Prices:	Drug price information for PULMICORT FLEXHALER
What excipients (inactive ingredients) are in PULMICORT FLEXHALER?	PULMICORT FLEXHALER excipients list
DailyMed Link:	PULMICORT FLEXHALER at DailyMed

See drug prices for PULMICORT FLEXHALER

See drug sales revenues for PULMICORT FLEXHALER

Recent Clinical Trials for PULMICORT FLEXHALER

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

Sponsor	Phase
AstraZeneca	Phase 1
Columbia University	Phase 4
West Penn Allegheny Health System	Phase 4

See all PULMICORT FLEXHALER clinical trials

Pharmacology for PULMICORT FLEXHALER

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for PULMICORT FLEXHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006		RX	Yes	No
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006		RX	Yes	Yes

Expired US Patents for PULMICORT FLEXHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006	6,142,145
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006	4,907,583
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006	7,143,764

EU/EMA Drug Approvals for PULMICORT FLEXHALER

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 FLEXHALER

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1019033
Estonia	03998	Inhaleeritav budesoniidi sisaldav ravimvorm puistetihedusega 0,28 kuni 0,38 g/ml
Sweden	9700133

Supplementary Protection Certificates for PULMICORT FLEXHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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

Market Dynamics and Financial Trajectory of Pulmicort Flexhaler (Budesonide Inhaler)

Introduction

Pulmicort Flexhaler, a brand name for the budesonide inhaler, is a crucial medication in the treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). This article delves into the market dynamics and financial trajectory of budesonide inhalers, with a focus on Pulmicort Flexhaler.

Market Size and Growth

The global budesonide inhaler market, which includes Pulmicort Flexhaler, has been experiencing significant growth. As of 2022, the market size was valued at US$ 6,899.6 million and is expected to grow at a Compound Annual Growth Rate (CAGR) of 6.0% from 2022 to 2030[1].

Key Drivers of Growth

Increasing Prevalence of Asthma and COPD

The rising prevalence of asthma and COPD globally is a major driver for the growth of the budesonide inhaler market. In the U.S., for instance, 8.4% of adults and 5.8% of children under 18 have been diagnosed with asthma, while 5.0% of the population has been diagnosed with COPD[1][3].

Generic Versions and Patent Expiry

The emergence of generic versions of budesonide inhalers, following the expiry of patented drugs, has expanded the market. Companies like Cipla and Viatris have received approvals for generic versions, which are expected to drive market growth. For example, Viatris launched Breyna, a generic version of AstraZeneca’s Symbicort, approved by the U.S. FDA for COPD and asthma treatment[4].

Strong Healthcare Infrastructure

The growth in healthcare infrastructure, particularly in regions like the Asia Pacific, has enhanced the diagnosis and treatment rates of respiratory diseases, further boosting the demand for budesonide inhalers[3].

Favourable Reimbursement Policies

Favourable reimbursement policies in many countries have made budesonide inhalers more accessible, thereby increasing their adoption[3].

Regional Market Dynamics

Asia Pacific Dominance

The Asia Pacific region, particularly China, has been the largest market for budesonide inhalers and is expected to continue growing at a substantial CAGR. China's large population and increasing healthcare spending are key factors contributing to this growth[3].

U.S. Market

In the U.S., the increasing prevalence of chronic obstructive pulmonary disease and asthma is expected to boost the growth of the budesonide inhaler market. North America held the largest share in the anti-inflammatory inhaler landscape in 2023 and is expected to maintain this position during the forecast period[4].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the budesonide inhaler market:

Increased Demand

The pandemic led to an increased demand for budesonide inhalers due to their use in treating respiratory illnesses. A study by the University of Oxford found that early treatment with inhaled budesonide shortens recovery time in non-hospitalized COVID-19 patients by a median of three days[1][3].

Production and Supply Chain Disruptions

However, the pandemic also caused production and supply chain disruptions, affecting the availability of raw materials and limiting workforce operations, which moderately affected the industry's growth[3].

Financial Performance of Key Players

AstraZeneca

AstraZeneca, the original manufacturer of Pulmicort Flexhaler, has seen significant financial performance. In 2023, AstraZeneca reported a total revenue increase of 18% to $25,617 million, driven by an 18% increase in product sales and continued growth in alliance revenue. However, the company noted a substantial decrease in other operating income due to the disposal of Pulmicort Flexhaler US rights in the previous year[5].

Generic Competition and Market Expansion

Launch of Generic Versions

The launch of generic versions of budesonide inhalers has expanded the market. For example, Viatris's launch of Breyna, a generic version of Symbicort, has provided a cost-effective alternative for patients suffering from COPD and asthma[4].

Market Share and Competition

The budesonide inhaler market is highly competitive, with key players including Pfizer Inc., Cipla Ltd., Lupin Limited, and Aurobindo Pharma Limited. The introduction of generic versions has widened the consumer base, especially in low- and middle-income economies[4].

Future Outlook

The budesonide inhaler market, including Pulmicort Flexhaler, is poised for continued growth driven by:

• Increasing prevalence of respiratory diseases
• Strong healthcare infrastructure
• Favourable reimbursement policies
• Emergence of generic versions
• Technological advancements in the medical industry

The Asia Pacific region, particularly China, is expected to continue its dominance, while North America will remain a significant market due to the high prevalence of asthma and COPD[3][4].

Key Takeaways

• The global budesonide inhaler market is projected to reach USD 13.6 billion by 2034.
• The Asia Pacific region, particularly China, is the largest market and is expected to grow substantially.
• Respiratory disease treatment is the fastest-growing application segment.
• Budesonide/formoterol combinations are cost-effective and reduce healthcare costs.
• The COVID-19 pandemic has driven demand but also caused production disruptions.

FAQs

What is the current market size of the budesonide inhaler market?

The budesonide inhaler market was valued at US$ 6.8 billion in 2023 and is expected to grow at a CAGR of 6.6% from 2024 to 2034[4].

How has the COVID-19 pandemic affected the budesonide inhaler market?

The COVID-19 pandemic has led to an increased demand for budesonide inhalers due to their use in treating respiratory illnesses, but it has also caused production and supply chain disruptions[1][3].

What are the key drivers of growth for the budesonide inhaler market?

Key drivers include the increasing prevalence of asthma and COPD, the emergence of generic versions, strong healthcare infrastructure, and favourable reimbursement policies[1][3][4].

Which region dominates the budesonide inhaler market?

The Asia Pacific region, particularly China, is the largest market for budesonide inhalers and is expected to continue growing at a substantial CAGR[3].

What is the impact of generic versions on the budesonide inhaler market?

The introduction of generic versions has expanded the market, making budesonide inhalers more accessible and affordable, especially in low- and middle-income economies[4].

Sources

1. Coherent Market Insights: Budesonide Inhaler Market Size and Trends.
2. AstraZeneca: Q1 2024 results announcement.
3. Drug Patent Watch: Generic BUDESONIDE INN equivalents, drug patent expiry and market dynamics.
4. Transparency Market Research: Budesonide Inhaler Market Size, Share & Trends, Forecast - 2034.
5. Business Wire: AstraZeneca's H1 and Q2 2024 Financial Results.