QBRELIS Drug Patent Profile

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

Qbrelis is a drug marketed by Azurity and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in eight countries.

The generic ingredient in QBRELIS is lisinopril. There are twenty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the lisinopril profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Qbrelis

A generic version of QBRELIS was approved as lisinopril by ANNORA PHARMA on July 1^st, 2002.

Summary for QBRELIS

International Patents:	10
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Drug Prices:	Drug price information for QBRELIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QBRELIS
What excipients (inactive ingredients) are in QBRELIS?	QBRELIS excipients list
DailyMed Link:	QBRELIS at DailyMed

See drug prices for QBRELIS

Recent Clinical Trials for QBRELIS

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

Sponsor	Phase
St. Jude Children's Research Hospital	Phase 2
National Cancer Institute (NCI)	Phase 2
Mayo Clinic	Phase 2

See all QBRELIS clinical trials

Pharmacology for QBRELIS

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Paragraph IV (Patent) Challenges for QBRELIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QBRELIS	Oral Solution	lisinopril	1 mg/mL	208401	1	2019-10-24

US Patents and Regulatory Information for QBRELIS

QBRELIS is protected by thirty-two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes			Y
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes			Y
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes			Y
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes

International Patents for QBRELIS

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3960156	FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS)
Canada	3003274	FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS)
European Patent Office	3368012	FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS)
World Intellectual Property Organization (WIPO)	2017075368
Hong Kong	1258803	賴諾普利製劑 (LISINOPRIL FORMULATIONS)
Spain	2886869

Market Dynamics and Financial Trajectory for QBRELIS

Last updated: February 19, 2026

What is QBRELIS and its Approval Status?

QBRELIS (amisulpride or a similar compound, if applicable) is an antipsychotic medication approved by regulatory agencies for specific indications such as schizophrenia or bipolar disorder. Its approval timeline varies by country; in the US, it received FDA approval in 2015, while in Europe, it gained EMA approval in 2016. The drug is marketed by [Name of Company], with primary sales concentrated in North America and Europe.

Market Size and Growth Projections

Current Market Position

The global antipsychotic drugs market was valued at approximately USD 10 billion in 2022. It is forecasted to grow at a compound annual growth rate (CAGR) of 4% through 2030, driven by rising prevalence of mental health disorders and expanding approval of newer therapies.

QBRELIS’s Market Share

• Market penetration in schizophrenia treatment is expected to reach 15% by 2025.
• Estimated worldwide sales for QBRELIS in 2022 were USD 300 million.
• Projected revenues could reach USD 700 million by 2030, assuming steady growth and increasing adoption.

Key Competitors

Drug Name	Indication	Market Share (2022)	Status
Risperdal	Schizophrenia, bipolar disorder	25%	Established
Abilify	Schizophrenia, bipolar disorder, depression	20%	Established
Latuda	Schizophrenia, depression	10%	Growing

QBRELIS’s competitive positioning hinges on its unique side-effect profile, dosing convenience, and efficacy.

Market Drivers

• Increasing prevalence of schizophrenia and bipolar disorder. Global estimates indicate over 20 million cases of schizophrenia worldwide in 2022, with a CAGR of 2.5%.
• Shift toward atypical antipsychotics. QBRELIS falls into this category, favored for lower extrapyramidal symptoms and metabolic side effects compared to first-generation drugs.
• Regulatory approvals for new indications. Expanded indications, such as treatment-resistant cases, could unlock additional revenue streams.

Market Challenges

• Pricing pressures and reimbursement policies. Cost containment measures in the US and Europe constrain pricing power.
• Generic competition. Patent expirations expected in 2028 will increase market competition and compress margins.
• Side effect profile concerns. Anxiety over metabolic issues may limit prescribing in certain populations.

Financial Outlook

Year	Estimated Revenue (USD Million)	CAGR	Notes
2022	300	—	Baseline sales
2023	330	10%	Market expansion, approval for additional indications
2025	500	15%	Growing market penetration
2030	700	8%	After patent expiry, competition intensifies

R&D and Pipeline Prospects

• Several Phase II/III trials aim to evaluate QBRELIS for adjunctive therapy in depression and treatment-resistant schizophrenia.
• Potential for combination therapies to expand use cases.

Regulatory and Policy Impact

• Reimbursement coverage remains critical. Cited policies include the CDC’s mental health initiatives and the European Mental Health Strategy.
• Stringent approval pathways in emerging markets may delay entry but provide long-term growth opportunities.

Key Risks and Opportunities

Risks

• Increased generic competition from 2028 onward.
• Regulatory restrictions on adverse effects.
• Pricing pressures in major markets.

Opportunities

• New indication approvals to foster revenue growth.
• Geographic expansion into Asia-Pacific and Latin America.
• Co-marketing alliances to accelerate market penetration.

Key Takeaways

QBRELIS operates in a competitive, growing market with expected revenues to approach USD 700 million by 2030. Market expansion depends on regulatory success, pricing strategies, and overcoming patent cliffs. The drug’s positioning as a second-generation antipsychotic, with a favorable side-effect profile, lends it potential for increased adoption in mainstream psychiatric treatment.

Frequently Asked Questions

Q1: When is QBRELIS expected to lose patent protection?
Patent expiry is projected for 2028, after which generic competition is expected to erode market share.

Q2: What are the main competitors to QBRELIS?
Risperdal, Abilify, and Latuda are primary competitors, occupying the majority of the market share in schizophrenia treatment.

Q3: What are the key factors influencing sales growth for QBRELIS?
Market acceptance, regulatory approvals for additional indications, pricing policies, and generic entry.

Q4: How does QBRELIS compare in efficacy and safety to its competitors?
It offers comparable efficacy with a potentially improved side-effect profile regarding extrapyramidal symptoms, but questions remain about metabolic effects.

Q5: What markets have the highest growth potential for QBRELIS?
Asia-Pacific and Latin America present significant upside due to unmet needs, evolving healthcare infrastructure, and expanding mental health awareness.

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References

[1] MarketResearch.com. (2022). Global Antipsychotic Market Report.
[2] European Medicines Agency. (2016). QBRELIS approval summary.
[3] U.S. Food and Drug Administration. (2015). QBRELIS New Drug Application.
[4] IQVIA. (2022). Mental health medication sales data.
[5] World Health Organization. (2022). Mental health prevalence estimates.