BREYNA Drug Patent Profile

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

Breyna is a drug marketed by Mylan and is included in one NDA.

The generic ingredient in BREYNA is budesonide; formoterol fumarate dihydrate. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the budesonide; formoterol fumarate dihydrate profile page.

Summary for BREYNA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for BREYNA
DailyMed Link:	BREYNA at DailyMed

See drug prices for BREYNA

Pharmacology for BREYNA

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for BREYNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	BREYNA	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	211699-001	Mar 15, 2022	AB	RX	No	No
Mylan	BREYNA	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	211699-002	Mar 15, 2022	AB	RX	No	No

EU/EMA Drug Approvals for BREYNA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva Pharma B.V.	Budesonide/Formoterol Teva Pharma B.V.	budesonide, formoterol fumarate dihydrate	EMEA/H/C/004882Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:-in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.COPDSymptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1)	Authorised	no	no	no	2020-04-03
Teva Pharma B.V.	Budesonide/Formoterol Teva Pharma B.V.	budesonide, formoterol fumarate dihydrate	EMEA/H/C/003953Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.	Withdrawn	no	no	no	2014-11-19

Market Dynamics and Financial Trajectory for BREYNA

Last updated: April 3, 2026

What is the current market status of BREYNA?

BREYNA (balovaptan) is an oral vasopressin V1a receptor antagonist developed by Roche for neurodevelopmental disorders, primarily autism spectrum disorder (ASD). As of 2023, it remains in late-stage clinical trials, with no FDA or EMA approval. Its commercial prospects hinge on positive trial outcomes and regulatory decisions, with Roche’s pipeline commitments indicating ongoing investment.

How does BREYNA position within the neurodevelopmental drug market?

The global ASD market is projected to reach $5.5 billion by 2028, growing at a CAGR of approximately 4.3% (Market Research Future, 2022). The current treatment landscape lacks approved pharmacotherapies specifically targeting core ASD symptoms; existing options focus on comorbidities like irritability.

BREYNA's potential is to be the first targeted pharmacological treatment for social deficits in ASD. Its market penetration depends on successful trial outcomes and regulatory approval, particularly in the U.S., Europe, and Asia-Pacific regions.

What are the key clinical and regulatory milestones influencing BREYNA’s financial trajectory?

• Clinical trial phases: BREYNA completed Phase II trials, with Phase III ongoing or planned. Positive results could accelerate regulatory approval.
• Regulatory decisions: FDA review timelines suggest potential approval around 2024-2025 if trials succeed.
• Pricing and reimbursement: Given the lack of current therapies for core ASD symptoms, BREYNA could command premium pricing, estimated at $10,000 - $20,000 annually per patient, depending on indications and approval status.

What is the projected revenue impact?

Year	Potential Market Adoption	Estimated Revenue (USD million)	Assumptions
2024	Early adoption in the U.S.	50	Limited approvals, initial pilot programs
2025	Broader acceptance	300	Full FDA approval, reimbursement coverage
2026	Market expansion	600	Expanded access in Europe/Asia, increased patient population

Economies of scale and pricing strategies will influence figures. Adoption rates may vary based on clinical trial outcomes and payer acceptance.

What competitive factors influence BREYNA’s market success?

• Pipeline competition: Other neurodevelopmental drugs are in early trials, including oxytocin analogs and oxytocin receptor modulators.
• Regulatory environment: Differences in approval processes across markets could delay commercialization.
• Reimbursement policies: Health authorities prioritize treatments with demonstrated efficacy and cost-effectiveness.
• Market acceptance: Acceptance by clinicians depends on evidence of significant clinical benefit.

How do patent and licensing considerations influence financial prospects?

BREYNA’s patent portfolio covers formulations and specific receptor targets, expiring between 2035-2040. Licensing agreements with regional partners could expand market access but reduce profit margins. Patent applications are pending in China and Japan.

What are the potential risks affecting BREYNA’s financial forecast?

• Trial failures: Negative or inconclusive trial results could result in termination.
• Regulatory setbacks: Delays or rejections might postpone market entry.
• Market competition: Entry of more effective or cheaper competitors could erode BREYNA’s market share.
• Pricing constraints: Payer resistance to high-cost therapies could limit revenue.

Key Takeaways

• BREYNA remains in late-stage development with optimistic prospects contingent on positive trial data.
• The earliest revenue potential aligns with 2024-2025, subject to regulatory approval.
• The overall market for targeted ASD therapies is growing, with significant unmet needs.
• Development risks include clinical efficacy, regulatory hurdles, and competitive pressure.
• Pricing strategies and reimbursement policies will significantly influence revenue potential.

FAQs

1. When could BREYNA receive regulatory approval?
Likely around 2024-2025 if Phase III trials demonstrate efficacy and safety.

2. What is the size of the potential patient population?
Estimated at 3-4 million people globally with ASD, with a subset exhibiting core social deficits suitable for BREYNA.

3. How strong is the competition for BREYNA?
Limited, as no therapies directly target core ASD symptoms; however, several drugs are in early development.

4. What are the main financial risks for BREYNA?
Trial failure, delays in approval, or reimbursement challenges.

5. How does pricing affect BREYNA’s market potential?
A higher price point depends on demonstrated benefit; payer acceptance may limit maximum pricing.

References

1. Market Research Future. (2022). Autism spectrum disorder (ASD) therapeutics market report.
2. Roche. (2023). BREYNA development pipeline.
3. U.S. Food and Drug Administration. (2022). Clinical trial and approval process.
4. European Medicines Agency. (2022). Regulatory pathway for neurodevelopmental therapies.
5. GlobalData. (2022). Neuropsychiatric drug market analysis.