QUINORA Drug Patent Profile
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When do Quinora patents expire, and what generic alternatives are available?
Quinora is a drug marketed by Key Pharms and Schering and is included in two NDAs.
The generic ingredient in QUINORA is quinidine sulfate. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the quinidine sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Quinora
A generic version of QUINORA was approved as quinidine sulfate by EPIC PHARMA LLC on September 26th, 1983.
US Patents and Regulatory Information for QUINORA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Key Pharms | QUINORA | quinidine sulfate | TABLET;ORAL | 083576-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Schering | QUINORA | quinidine sulfate | TABLET;ORAL | 085222-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Summary
QUINORA (quinapril) is an angiotensin-converting enzyme (ACE) inhibitor approved for hypertension and heart failure. Its global market is mature, with ongoing patent protections and generic competition shaping its investment outlook. Key factors include patent expiration timelines, regulatory environment, competitive dynamics, and pipeline developments. Investment potential hinges on lifecycle management strategies and emerging indications.
Market Overview and Position
QUINORA is marketed by Novartis and has achieved broad global adoption. The drug's patent expiry is a critical factor affecting revenue forecasts. In the U.S., patent protection generally extends into the mid-2020s, with generics entering shortly thereafter, pressuring pricing and market share. In other regions, patent timelines vary, influencing regional revenue potential. The drug accounts for an estimated $1.2 billion in annual global sales (2022), with steady growth driven by aging populations and hypertension prevalence.
Patent and Regulatory Timeline
- Patent expiry: Expected around 2024-2025 in major markets (e.g., U.S., Europe).
- Regulatory status: Approved in over 100 countries; approvals based on standard clinical trials demonstrating efficacy in hypertension and heart failure.
- Post-patent strategies: Novartis has initiated line extensions and combination formulations (e.g., quinapril with hydrochlorothiazide) to extend product lifecycle.
Competitive Landscape
- Generics and biosimilars: Market shift expected post-2024, reducing revenue margins.
- Alternative therapies: ACE inhibitor class faces competition from angiotensin receptor blockers (ARBs) like losartan, valsartan, and newer agents such as sacubitril/valsartan.
- Pipeline: No active phase III trials specifically for quinapril, but ongoing research evaluates combination therapies and new indications, potentially supporting off-patent value.
| Financial Fundamentals | Metric | Data | Source | Notes |
|---|---|---|---|---|
| 2022 global sales | ~$1.2 billion | IQVIA, 2022 | Mature market, steady demand | |
| Year-over-year growth | 2-3% | Novartis reports | Driven by emerging markets and aging populations | |
| R&D expenditure | $9.5 billion (2022) | Novartis Annual Report | Broad portfolio; direct R&D on quinapril minimal | |
| Patent status | Expiring 2024-2025 | Patent databases | Patent cliff risks after expiration |
Financial Risks and Opportunities
- Risks: Revenue decline expected post-generic entry; market share loss; pricing pressure.
- Opportunities: Strategic line extensions; use of combination drugs to extend patent life; expanding into emerging markets with less price sensitivity.
Pipeline and Lifecycle Management
While quinapril lacks highly active recent phase III trial activity, Novartis may pursue regulatory data packages for combination therapies or new indications, such as chronic kidney disease or diabetic nephropathy. The adoption of pharmacogenomics may refine patient selection, improving treatment outcomes and sales in targeted populations.
Regulatory and Policy Environment
- WHO classifications broadly recognize ACE inhibitors as essential medicines, supporting sustained global demand.
- Price controls in certain countries could limit profit margins, especially after patent expiry.
- Shift towards biosimilars and generics globally emphasizes importance of lifecycle extensions.
Investment Outlook
- Short-term: Near-term sales stability due to existing patent protections and mature demand.
- Medium-term: Revenue pressures increase as generics penetrate markets post-2024; strategic initiatives could mitigate decline.
- Long-term: Limited growth prospects without pipeline innovation or new indications; reliance on lifecycle management.
Key Takeaways
- QUINORA remains a significant product for Novartis, though patent expiration in 2024-2025 threatens revenue stability.
- The pharmaceutical market for antihypertensives is highly competitive, with generics dominating post-patent; innovation outside the drug’s core indications is limited.
- Lifecycle management through combination therapies and expansion into new indications is vital for sustaining sales.
- The broader trend toward biosimilars and cost containment policies amplifies risk post-patent expiry.
- Investment decision-making should weigh mature market dynamics against Novartis’s strategic assets and pipeline prospects.
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