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-seven 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
Patent Applications:	298
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
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes			Y

International Patents for QBRELIS

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

Country	Patent Number	Title	Estimated Expiration
Canada	3003274	FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS)
China	108472252	赖诺普利制剂 (LISINOPRIL FORMULATIONS)
China	112972370	赖诺普利制剂 (LISINOPRIL FORMULATIONS)
European Patent Office	3368012	FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS)
European Patent Office	3960156	FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS)
Spain	2886869
Hong Kong	1258803	賴諾普利製劑 (LISINOPRIL FORMULATIONS)

QBRELIS (quinapril hydrochloride) market dynamics and financial trajectory: revenue exposure, competition, and IP-driven launch risk

Last updated: July 28, 2026

QBRELIS is an authorized brand of quinapril hydrochloride, a long-established ACE inhibitor used for hypertension and heart failure indications. The commercial trajectory is driven less by new clinical science and more by (1) generic penetration across the ACE inhibitor class, (2) payer step therapy and formulary positioning, and (3) any remaining brand-level exclusivity or product-specific IP that delays generic substitution. Without current, drug-specific net sales and payer coverage data, the financial trajectory cannot be quantified to a defensible year-by-year series.

What is QBRELIS (quinapril hydrochloride) and what sales drivers determine its market dynamics?

QBRELIS is quinapril hydrochloride, an oral ACE inhibitor. In the US, the primary market structure for oral ACE inhibitors is mature and generic-dominated. Market dynamics typically hinge on:

• Formulary tier placement versus generic enalapril, lisinopril, benazepril, ramipril, and other quinapril AB-rated products.
• Payer utilization management including prior authorization and step edits, especially where lowest-cost ACE inhibitors are preferred.
• Switchability driven by interchangeability in the same active ingredient class.
• Patient persistence and tolerability for ACE inhibitor class members, which are usually substitutable at pharmacy level.

Featured snippet answer: QBRELIS competes in a mature ACE inhibitor market where generic substitution, formulary tiering, and payer controls typically determine brand-level performance more than new differentiation.

Which therapeutic areas does QBRELIS target and how does that affect demand?

ACE inhibitors have two key demand pools:

• Hypertension: long-duration therapy, high volume, high generic sensitivity.
• Heart failure (including reduced ejection fraction contexts): smaller pool than hypertension, but still highly generic substitutable.

Because both pools are chronic and generics dominate, brand demand typically depends on localized payer preferences, patient stability, and contracted pricing rather than net-new prescriber adoption.

How do ACE inhibitor competitive dynamics translate to QBRELIS pricing power?

For mature ACE inhibitors:

• List price discounts are common even when brands retain some formulary share.
• Wholesaler buy trends and patient-share are usually the main signals of brand resilience.
• Competition is primarily price and access, not molecule novelty.

What patents protect QBRELIS and how do they affect its financial trajectory?

A brand’s financial trajectory in a mature drug class is typically determined by:

• Product-specific composition/formulation IP (if any),
• Method-of-use IP (less common for old actives at the brand level),
• Orange Book listing status that can block or delay generic entry,
• Remaining exclusivity windows (if any) beyond base approval.

Constraint: A complete, accurate patent and Orange Book protection map for QBRELIS requires current Orange Book listings and associated patent numbers, expiration dates, and exclusivity codes. Without those drug-specific records in this prompt, a defensible protection landscape cannot be produced.

When does QBRELIS lose exclusivity and what generic entry risks exist?

For ACE inhibitors, the generic entry risk is structurally high:

• The active ingredient quinapril hydrochloride is long off-patent in practice, and
• Brand resilience usually depends on whether the brand has any remaining listed patents or formulation-specific barriers for its exact dosage forms/strengths.

Constraint: A QBRELIS-specific “loss of exclusivity” and Paragraph IV/Orange Book barrier assessment requires the exact Orange Book drug submission entries (strength, dosage form, application reference) and the listed patent set. Those data are not provided in the prompt, so a precise exclusivity timeline cannot be generated.

What is the Orange Book status of QBRELIS and how does it shape payer substitution behavior?

Orange Book status influences generic substitution through two channels:

• Regulatory eligibility for FDA approval of ANDAs with paragraph IV certifications or patent waivers.
• Litigation and settlement timing that can extend market exclusivity for specific branded presentations.

Constraint: The QBRELIS Orange Book list (application number, applicant, listed patents, expiration dates, exclusivity type and date) is required for a correct status statement and cannot be derived from the prompt.

How does QBRELIS compare with other quinapril brands and ACE inhibitors on market penetration?

QBRELIS vs. other ACE inhibitors

Commercial reality for oral ACE inhibitors is:

• Generic ACE inhibitors dominate pharmacy spend.
• Market share is allocation and contract driven, not clinical differentiation.

In typical payer structures, ACE inhibitors are interchangeable from a drug-class perspective. That lowers brand price tolerance and caps sales growth.

QBRELIS vs. quinapril-specific alternatives

If multiple quinapril brands exist, brand-level share depends on:

• Net-to-wholesaler pricing and rebate structure.
• Formulary preferences tied to PBM contracting.
• Patient switching at refill.

Absent current market share and pricing data, only a directional assessment is possible: QBRELIS competes in a generic-dominant subgroup where payer economics favor the lowest net-cost quinapril product or alternative ACE inhibitor.

What market dynamics affect QBRELIS demand in the US, Medicare, Medicaid, and commercial plans?

Commercial plans

Commercial demand is sensitive to:

• Formulary tier positioning (preferred generic vs non-preferred brand).
• Copay design that can accelerate switching.
• Prior authorization that targets higher-cost brands when generics are available.

Medicare Part D

Part D often emphasizes:

• Preferred cost-sharing for generics.
• Plan bid dynamics that reward lowest-cost formulary options.

Medicaid

State formularies and preferred drug lists can further shift utilization to preferred ACE inhibitors and generics.

How do payer rebates and net price erosion typically influence QBRELIS financial performance?

In mature generic-substitutable classes:

• Brand revenue growth is usually limited by the rate at which generics capture coverage.
• Net revenue is influenced heavily by rebates and managed entry agreements.
• As generic penetration increases, brands often maintain volume only by increasing rebates or accepting lower net margins.

A defensible financial trajectory for QBRELIS requires audited revenue/COGS/SG&A and discounting details by year, which are not present in this prompt.

What does the revenue exposure look like for QBRELIS from a risk perspective?

For a brand in a mature ACE inhibitor market, the dominant risks are:

• Formulary tier degradation (conversion from preferred to non-preferred).
• Switching acceleration after competitor contracting changes.
• Generic supply dynamics that can briefly change relative pricing and access.

Practical exposure framing: Revenue variance is more likely driven by PBM contract outcomes and formulary decisions than by new clinical outcomes.

What QBRELIS manufacturing and supply-chain risks could impact financial trajectory?

For oral generics and branded ACE inhibitors, supply-chain disruption can create short-term sales spikes or losses via:

• Sourcing constraints for API or critical excipients,
• Batch quality events that restrict distribution,
• Warehouse allocation under tight supply.

This prompt does not contain QBRELIS site-level CMC history, FDA inspection history, or distribution events needed to quantify these factors.

How does QBRELIS patent litigation affect market entry timing and financial performance?

Patent litigation can alter launch timing for generics via:

• Injunctions or stay orders,
• Settlement-driven delayed entry,
• Judgment-driven earlier launches.

Constraint: A QBRELIS-specific litigation timeline requires case captions, jurisdiction, dockets, filing dates, and settlement terms, none of which are included in the prompt.

How does QBRELIS compare to the broader ACE inhibitor class in long-term financial durability?

Long-term durability of ACE inhibitors at the brand level is usually constrained because:

• Class molecules are old and generic,
• No broad class exclusivity exists once generics are approved,
• Clinician preference is not enough to resist payer economics.

If QBRELIS has any remaining product-specific barrier, durability could persist at a modest scale. Otherwise, brand-level performance typically declines as net price competitiveness deteriorates relative to generics.

Key Takeaways

• QBRELIS operates in a mature, highly substitutable ACE inhibitor market where formulary access and net pricing drive brand economics.
• Financial trajectory is most sensitive to payer contracting, tier placement, rebate pressure, and generic switching dynamics.
• A precise exclusivity, Orange Book, patent, and litigation impact assessment for QBRELIS cannot be produced from the information provided in this prompt.

FAQs

1. Why do brands like QBRELIS typically lose share after generic ACE inhibitor launches?
2. How do PBM formulary tier changes affect outpatient ACE inhibitor utilization over a 6 to 12 month horizon?
3. What settlement structures commonly delay generic entry for mature small-molecule drugs like quinapril?
4. How does Medicare Part D step therapy impact ACE inhibitor brand persistence?
5. What indicators most reliably predict future revenue decline for a mature brand in a generic-dominated class?

References

1. FDA Orange Book. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-07-28).