PULMICORT Drug Patent Profile

Which patents cover Pulmicort, and what generic alternatives are available?

Pulmicort is a drug marketed by Astrazeneca and Cheplapharm and is included in three NDAs.

The generic ingredient in PULMICORT 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

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

Summary for PULMICORT

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	79
Patent Applications:	5,828
Drug Prices:	Drug price information for PULMICORT
Drug Sales Revenues:	Drug sales revenues for PULMICORT
What excipients (inactive ingredients) are in PULMICORT?	PULMICORT excipients list
DailyMed Link:	PULMICORT at DailyMed

See drug prices for PULMICORT

See drug sales revenues for PULMICORT

Recent Clinical Trials for PULMICORT

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

Sponsor	Phase
Kafrelsheikh University	Phase 4
Bond Avillion 2 Development LP	Phase 1
University of Oxford	Phase 2

See all PULMICORT clinical trials

US Patents and Regulatory Information for PULMICORT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997		DISCN	No	No
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997		DISCN	No	No
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
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997

EU/EMA Drug Approvals for PULMICORT

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

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

Country	Patent Number	Title	Estimated Expiration
Finland	88679
Finland	89459
Ireland	57522	AN INDICATING MEANS FOR A DOSAGE DISPENSING DEVICE
Ireland	860897
Poland	237363
Portugal	82375	DISPOSITIVO INDICADOR PARA UM DISPOSITIVO DE DISTRIBUICAO DE DOSES
Yugoslavia	141482

Supplementary Protection Certificates for PULMICORT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	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
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

Market Dynamics and Financial Trajectory for Pulmicort

Introduction

Pulmicort, a brand name for the corticosteroid budesonide, is a widely used medication for 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 Pulmicort, highlighting key players, market trends, and financial performance.

Global Market Overview

The global Pulmicort market is part of the larger pharmaceutical industry, which was valued at $1.475 trillion in 2022 and is expected to grow at a CAGR of 5% over the next six years[1].

Market Size and Growth

As of 2023, the global Pulmicort market was estimated to be worth several million USD, with a forecasted growth to a readjusted size by 2030. The market is expected to grow at a significant CAGR, driven by increasing demand for respiratory disease treatments[1][4].

Key Players

The Pulmicort market is dominated by several major pharmaceutical companies:

• AstraZeneca: The original developer and marketer of Pulmicort.
• Teva: Known for its generic versions of Pulmicort.
• Mylan: Another significant player in the generic market.
• Sandoz: A Novartis division, offering generic and biosimilar versions.
• Cosmo Pharmaceuticals, Salix, Chiesi Farmaceutici, Orion Corporation, Cipla, Synmosa Biopharma, Lunan Better Pharma, and Shanghai Sine Promod also play crucial roles in the market[1].

Market Segmentation

The Pulmicort market is segmented based on type and application.

By Type

• Injectable Suspension: This segment accounted for a noticeable share of the global Pulmicort market in 2023 and is projected to experience significant growth in the near future[4].
• Aerosols: Another key segment, aerosols are widely used for respiratory disease treatment.

By Application

• Respiratory Disease Treatment: This segment is expected to expand at a significant CAGR, retaining its position throughout the forecast period. Pulmicort is primarily used for treating asthma and COPD[4].

Regional Analysis

The market is analyzed across five major regions:

• North America: A significant market due to high healthcare spending and a large patient base.
• Europe: Another major region with a strong pharmaceutical industry.
• Asia-Pacific: Expected to grow rapidly due to increasing healthcare needs and economic growth.
• Latin America: Showing potential for growth driven by improving healthcare infrastructure.
• Middle East and Africa: Also expected to contribute to the market growth, albeit at a slower pace[4].

Financial Performance of Key Players

AstraZeneca

AstraZeneca, the primary developer of Pulmicort, has seen significant financial growth in recent years.

• Total Revenue: In H1 2024, AstraZeneca reported a total revenue of $25,617 million, up 18% from the previous year, driven by an 18% increase in product sales and growth in alliance revenue[2].
• Product Sales: The company's product sales, excluding COVID-19 medicines, increased by 15% in Q1 2023, reflecting strong performance across various therapeutic areas[3].
• Divestment of Pulmicort Flexhaler: AstraZeneca gained $241 million from the disposal of US rights to Pulmicort Flexhaler in Q1 2023, contributing to its core other operating income[2][3].

Other Players

Other key players, such as Teva and Mylan, also contribute significantly to the market through their generic and biosimilar offerings. These companies focus on expanding their product portfolios and geographical presence to capture a larger market share.

Market Trends and Drivers

Increasing Prevalence of Respiratory Diseases

The rising incidence of asthma and COPD globally drives the demand for Pulmicort and similar medications. This trend is expected to continue, fueling market growth[4].

Technological Advancements

Advancements in drug delivery systems, such as inhalers and aerosols, enhance the efficacy and patient compliance of Pulmicort, contributing to its market growth[4].

Regulatory Environment

Regulatory approvals and updates play a crucial role in the market dynamics. For instance, updates to contractual arrangements for certain medications can significantly impact revenue, as seen in AstraZeneca's financial reports[2][3].

Challenges and Restraints

Generic Competition

The presence of generic and biosimilar versions of Pulmicort from companies like Teva and Mylan poses a significant challenge to the original brand, affecting its market share and revenue[1].

Patent Expirations

The expiration of patents for Pulmicort allows more generic versions to enter the market, increasing competition and potentially reducing the revenue of the original developer[4].

Economic Factors

Economic fluctuations, including changes in exchange rates and healthcare spending, can impact the market's financial trajectory. For example, AstraZeneca's financial performance is influenced by constant exchange rates and regional economic conditions[2][3].

Financial Trajectory

Revenue Growth

The Pulmicort market is expected to witness steady revenue growth driven by increasing demand for respiratory disease treatments. AstraZeneca's total revenue, excluding COVID-19 medicines, increased by 15% in Q1 2023, indicating a strong start to the year[3].

Profit Margins

The core product sales gross margin for AstraZeneca was 83% in Q1 2023, reflecting a mix shift to more specialty medicines and a decline in sales of lower-margin COVID-19 medicines[3].

EPS and Operating Margins

AstraZeneca's core EPS increased by 6% to $1.92 in Q1 2023, while the core operating margin was 36%, up one percentage point from the previous year. These metrics indicate a robust financial performance despite challenges[3].

Key Takeaways

• The global Pulmicort market is driven by the increasing prevalence of respiratory diseases and technological advancements in drug delivery systems.
• AstraZeneca remains a key player, with significant financial growth despite generic competition and patent expirations.
• The market is segmented by type and application, with injectable suspension and aerosols being key segments.
• Regional analysis shows potential for growth across various regions, with North America and Europe being significant markets.

FAQs

What are the main types of Pulmicort?

The main types of Pulmicort include injectable suspension and aerosols, with the injectable suspension segment accounting for a significant share of the global market[4].

Which region is expected to dominate the global Pulmicort market?

North America and Europe are expected to dominate the global Pulmicort market, although the Asia-Pacific region is also showing rapid growth potential[4].

What are the key drivers of the Pulmicort market?

The key drivers include the increasing prevalence of respiratory diseases, technological advancements in drug delivery systems, and strong financial performance of key players like AstraZeneca[4].

How does generic competition affect the Pulmicort market?

Generic competition from companies like Teva and Mylan poses a significant challenge to the original brand, affecting its market share and revenue[1].

What is the expected CAGR of the Pulmicort market?

The Pulmicort market is expected to grow at a significant CAGR, driven by increasing demand for respiratory disease treatments, although the exact CAGR figure varies by report[1][4].

Sources

1. Valuates Reports: Pulmicort - Market, Report Size, Worth, Revenue, Growth, Industry ...
2. Business Wire: AstraZeneca's H1 and Q2 2024 Financial Results
3. AstraZeneca: Q1-2023-results-announcement.pdf
4. Cognitive Market Research: Global Pulmicort Market Report 2024 Edition
5. BioSpace: AstraZeneca Full year and Q4 2023 Financial Results