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. Forty-two 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:	64
Clinical Trials:	13
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	Yes
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-002	Aug 8, 2000	AN	RX	Yes	Yes
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	020929-003	Aug 8, 2000	7,524,834*PED
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-001	Aug 8, 2000	4,787,536*PED
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-003	Aug 8, 2000	6,598,603*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/004655Jorveza 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/005653Kinpeygo 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
Norway	861064
Norway	327391
Israel	136086	PROCESS FOR PREPARATION OF STERILE GLUCOCORTICOSTEROIDS

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
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2435024	202140009	Slovenia		PRODUCT NAME: COMBINATION OF FORMOTEROL (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF), GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF) AND BUDESONIDE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF); NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF NATIONAL AUTHORISATION: 20201209; AUTHORITY FOR NATIONAL AUTHORISATION: EU

PULMICORT RESPULES: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

PULMICORT RESPULES (budesonide inhalation suspension) is a corticosteroid medication used for the maintenance treatment of asthma in patients aged 12 months to 8 years. The drug's market performance is influenced by patent exclusivity, generic competition, physician prescribing patterns, and patient adherence to treatment regimens.

What is PULMICORT RESPULES' Patent Status and Exclusivity Landscape?

PULMICORT RESPULES, developed by AstraZeneca, has experienced patent expiries. The primary patent for the active ingredient, budesonide, expired in the early 2000s. However, AstraZeneca has maintained market exclusivity for the PULMICORT RESPULES formulation through various strategies, including new formulations, method-of-use patents, and pediatric exclusivity.

• Original Patents: U.S. Patent No. 4,313,957, covering budesonide, expired on October 31, 2000.
• Pediatric Exclusivity: In the U.S., pediatric exclusivity can extend market protection for a drug if new clinical studies are conducted in children. AstraZeneca secured such exclusivity for PULMICORT RESPULES, which provided an additional six months of market protection in the U.S. following the expiry of other relevant patents. This exclusivity period concluded in May 2004.
• Formulation Patents: AstraZeneca has pursued patents related to specific formulations and delivery devices for budesonide. For example, U.S. Patent No. 6,446,650, related to a nebulizer device, was granted. The lifespan of these formulation patents is crucial for maintaining competitive advantage. The expiration dates of these formulation-specific patents directly impact the market entry timeline for generic competitors.
• Orange Book Listings: The U.S. Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the "Orange Book") lists patents and exclusivity periods for approved drugs. For PULMICORT RESPULES, these listings indicate periods of protection that have since expired, allowing for generic entry.

The expiration of key patents has opened the door for generic versions of budesonide inhalation suspension, intensifying competition.

Who are the Key Generic Competitors for PULMICORT RESPULES?

The entry of generic budesonide inhalation suspension has fragmented the market and exerted downward pressure on pricing. Several pharmaceutical companies have received FDA approval for their generic versions.

• Teva Pharmaceuticals: Teva was one of the first major players to launch a generic version of budesonide inhalation suspension in the U.S. Their product competes directly with PULMICORT RESPULES.
• Momenta Pharmaceuticals (now part of Generics): Momenta developed a generic version of PULMICORT RESPULES and engaged in litigation with AstraZeneca regarding patent infringements.
• Amneal Pharmaceuticals: Amneal also markets a generic version of budesonide inhalation suspension, contributing to market competition.
• Dr. Reddy's Laboratories: This company is another significant generic manufacturer with a budesonide inhalation suspension product available.
• Other Manufacturers: Numerous other smaller and international generic manufacturers have also entered the market, further increasing the supply of cost-effective alternatives.

These generic competitors typically launch their products once AstraZeneca's primary patent protection and any granted exclusivity periods have expired. The pricing of these generic alternatives is substantially lower than the originator product.

What is the Financial Performance and Market Size of PULMICORT RESPULES?

AstraZeneca's financial reporting for PULMICORT RESPULES prior to significant generic penetration indicated substantial revenue generation. Post-generic entry, the revenue trajectory for the branded product has declined, while the overall budesonide inhalation suspension market, encompassing both branded and generic versions, has seen shifts in value due to price competition.

• Peak Revenue: In its peak years before widespread generic competition, PULMICORT RESPULES generated annual revenues in the hundreds of millions of dollars for AstraZeneca. For instance, in 2010, global sales for PULMICORT were approximately $1.5 billion.
• Impact of Generic Entry: The introduction of generic budesonide inhalation suspension has led to a significant decrease in the market share and revenue for branded PULMICORT RESPULES. Generic drugs, by design, offer lower price points, forcing the originator product to compete on factors other than cost, such as brand recognition and physician trust.
• Market Value Shift: The overall market for budesonide inhalation suspension (including generics) may remain substantial in terms of unit volume. However, the total dollar value of the market has likely decreased due to the pricing erosion caused by generic competition.
• Global Sales Data: While specific current revenue figures for PULMICORT RESPULES are consolidated within AstraZeneca's respiratory portfolio and often not broken out individually after significant generic competition, historical data illustrates its past market dominance. For example, in 2014, PULMICORT (all formulations) reported sales of $1.04 billion globally, with a notable decline from previous years due to generic erosion.

Quantifying the exact current revenue of branded PULMICORT RESPULES is challenging as companies often combine sales of branded and generic equivalents or report them within broader therapeutic categories. However, the trend is demonstrably downward for the originator product.

How do Physician Prescribing Patterns Influence PULMICORT RESPULES' Market Position?

Physician prescribing habits are a critical determinant of PULMICORT RESPULES' market share, particularly in the face of generic alternatives. Factors such as perceived efficacy, familiarity, formulary status, and cost considerations influence these patterns.

• Brand Loyalty: Many physicians who have successfully treated asthma patients with PULMICORT RESPULES for years may exhibit brand loyalty, continuing to prescribe the branded product due to familiarity and trust in its performance and safety profile.
• Generic Prescribing Mandates: In some healthcare systems and insurance plans, there are mandates or strong incentives for physicians to prescribe generic medications whenever a therapeutically equivalent option is available. This can significantly steer prescribers away from branded PULMICORT RESPULES.
• Cost-Effectiveness Considerations: While PULMICORT RESPULES offers a specific formulation and delivery system, generic budesonide inhalation suspensions are significantly cheaper. Healthcare providers and payers increasingly prioritize cost-effectiveness, leading to a preference for generics unless there is a compelling clinical reason for the branded product.
• Patient Demographics and Insurance: The age group targeted by PULMICORT RESPULES (12 months to 8 years) involves parental decision-making and insurance coverage. If a patient's insurance plan has a high co-pay for the branded product and a low co-pay for the generic, parents may opt for the generic.
• Clinical Equivalence Debate: While generic drugs are proven to be bioequivalent, subtle differences in excipients or manufacturing processes can, in rare instances, lead to perceived differences in patient response. However, for inhaled corticosteroids like budesonide, regulatory bodies deem generics therapeutically equivalent.
• Physician Education and Awareness: The extent to which physicians are aware of and trust the bioequivalence and efficacy of generic budesonide inhalation suspensions directly impacts their prescribing decisions.

Physician familiarity and established treatment protocols represent a persistent, albeit diminishing, advantage for PULMICORT RESPULES. However, the economic realities of healthcare and payer policies increasingly favor generic options.

What are the Key Reimbursement and Payer Policies Affecting PULMICORT RESPULES?

Reimbursement policies set by insurance companies and government payers significantly shape the accessibility and affordability of PULMICORT RESPULES, impacting its market penetration and the uptake of its generic alternatives.

• Formulary Placement: Insurance formularies categorize drugs based on their cost-effectiveness and clinical value. PULMICORT RESPULES, as a branded drug facing generic competition, is likely placed on higher tiers with increased patient co-pays compared to generic budesonide inhalation suspensions, which are typically preferred and placed on lower tiers.
• Step Therapy: Many payers implement step therapy protocols, requiring patients to try less expensive, therapeutically equivalent medications (i.e., generics) before approving coverage for more expensive branded drugs. This means patients would generally need to use generic budesonide inhalation suspension first.
• Prior Authorization: For branded PULMICORT RESPULES, payers may require prior authorization, a process where the prescriber must justify the medical necessity of the branded drug over its generic alternative. This adds administrative burden and delays access.
• Co-Pay and Deductible Structures: The out-of-pocket cost for patients is heavily influenced by co-pay amounts and deductibles. Higher co-pays for branded PULMICORT RESPULES make them less attractive to patients compared to generics with lower or zero co-pays.
• Medicaid and Medicare Reimbursement: Government programs like Medicaid and Medicare have their own drug pricing and reimbursement policies, often favoring generics to control healthcare spending.
• Wholesaler and Pharmacy Markups: While not directly a payer policy, the pricing structure downstream from the manufacturer, including wholesaler markups and pharmacy dispensing fees, also contributes to the final patient cost. Generic products generally have lower wholesale acquisition costs, leading to lower overall costs.

Payer policies are a primary driver in the shift towards generic budesonide inhalation suspensions, actively discouraging the use of branded PULMICORT RESPULES for cost containment.

What is the Future Outlook for PULMICORT RESPULES and the Budesonide Inhalation Suspension Market?

The future market trajectory for PULMICORT RESPULES is characterized by continued competition from generic alternatives, with its market share likely to remain significantly diminished. The overall market for budesonide inhalation suspension will be driven by the volume of pediatric asthma patients and the pricing dynamics of generic competition.

• Continued Generic Dominance: Generic budesonide inhalation suspension is expected to maintain its dominant position in the market due to cost advantages and payer preferences. The number of generic manufacturers is likely to remain stable or increase, further intensifying price competition.
• Niche Market for Brand: Branded PULMICORT RESPULES may retain a small market share among patients with specific insurance plans that offer favorable coverage, or those whose physicians strongly advocate for its continued use based on long-term patient history.
• Innovation in Delivery Systems: While the active ingredient has been around for decades, innovation might focus on next-generation nebulizer devices or combination therapies. However, the primary driver of the budesonide inhalation suspension market remains generic accessibility.
• Pediatric Asthma Prevalence: The demand for budesonide inhalation suspension is tied to the prevalence of persistent asthma in young children. Trends in childhood asthma rates will influence the overall unit volume of this medication class.
• Pricing Pressure: Sustained pricing pressure from generic competition will continue to limit the revenue potential for any remaining branded product. Manufacturers of generic budesonide inhalation suspension will likely engage in price wars to gain or maintain market share.
• AstraZeneca's Portfolio Shift: For AstraZeneca, the strategic focus will have shifted away from maximizing PULMICORT RESPULES revenue towards newer respiratory assets or other therapeutic areas.

The market has fundamentally transitioned from one dominated by a branded originator to a highly competitive generic landscape.

Key Takeaways

• PULMICORT RESPULES' patent protection has expired, leading to the market entry of multiple generic budesonide inhalation suspension products.
• Key generic competitors include Teva Pharmaceuticals, Momenta Pharmaceuticals, Amneal Pharmaceuticals, and Dr. Reddy's Laboratories, among others.
• Branded PULMICORT RESPULES experienced peak annual sales in the hundreds of millions of dollars, but revenue has significantly declined post-generic entry.
• Physician prescribing is influenced by brand loyalty, generic mandates, and cost-effectiveness, with a general trend favoring generics.
• Reimbursement policies, including formulary placement, step therapy, and prior authorization, actively promote the use of generic budesonide inhalation suspension.
• The future market is characterized by continued generic dominance and significant pricing pressure, with branded PULMICORT RESPULES likely retaining a minimal market share.

Frequently Asked Questions

1. What is the primary reason for the decline in PULMICORT RESPULES sales? The primary reason is the loss of market exclusivity due to patent expiration, allowing for the introduction of significantly cheaper generic budesonide inhalation suspension products.

2. Are generic budesonide inhalation suspensions considered therapeutically equivalent to PULMICORT RESPULES? Yes, regulatory bodies like the FDA consider generic budesonide inhalation suspensions to be therapeutically equivalent to PULMICORT RESPULES, meaning they are expected to have the same efficacy and safety profiles.

3. How do insurance companies typically cover PULMICORT RESPULES versus its generic alternatives? Insurance companies generally place generic budesonide inhalation suspensions on lower, preferred formulary tiers with lower co-pays and may require patients to use generics through step therapy or prior authorization before approving the branded PULMICORT RESPULES.

4. What factors might lead a physician to still prescribe branded PULMICORT RESPULES? A physician might still prescribe branded PULMICORT RESPULES for a patient with a long history of successful treatment, if there are specific insurance benefits that make the branded product more accessible for that individual, or if the physician has concerns not addressed by generic bioequivalence data.

5. What is the market size for the overall budesonide inhalation suspension category, including generics? While precise current figures for the combined branded and generic market are not consistently reported by individual companies, the overall unit volume remains substantial due to the prevalence of pediatric asthma. However, the total dollar value of this market has decreased significantly due to generic price competition.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from www.fda.gov/drugs/development-approval-process/orange-book-approved-drug-products-therapeutic-equivalence-evaluations [2] AstraZeneca plc. (2011). Annual Report 2010. [3] AstraZeneca plc. (2015). Annual Report 2014. [4] Various pharmaceutical company press releases and FDA ANDA approval announcements (details vary by specific generic product).