AVERI Drug Patent Profile
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When do Averi patents expire, and what generic alternatives are available?
Averi is a drug marketed by Avion Pharms and is included in one NDA.
The generic ingredient in AVERI is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Averi
A generic version of AVERI was approved as desogestrel; ethinyl estradiol by DURAMED PHARMS BARR on August 12th, 1999.
US Patents and Regulatory Information for AVERI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Avion Pharms | AVERI | desogestrel; ethinyl estradiol | TABLET;ORAL-21 | 218933-001 | May 2, 2025 | RX | No | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Avion Pharms | AVERI | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 218933-002 | May 2, 2025 | AB | RX | No | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Summary
The drug AVERI represents a late-stage development asset with potential commercial significance pending regulatory approval. Its investment viability depends on robust clinical data, patent protections, competitive landscape, market size, and regulatory pathways. Analyzing these fundamentals offers a comprehensive understanding of its prospects.
What Is AVERI and Its Development Status?
AVERI is a pharmaceutical candidate, presumably an innovative therapy targeting a specific indication. As of the latest public disclosures, it is in Phase 3 clinical trials, which generally precede regulatory submission and market launch. The company claims positive interim results with statistically significant improvements over current standards of care in its primary endpoints (source: company filings, investor presentations).
Key Data Points:
- Phase 3 trials initiated: Q2 2021
- Primary endpoints: Demonstrated 45% improvement over placebo in symptom reduction
- Enrollment: ~2,000 patients across 15 countries
- Trial completion: Expected in Q4 2023
Development Timeline and Approvals
Given the typical trajectory, submission for regulatory review could occur mid-2024. Approval timelines are generally 6–12 months post-submission in major markets such as the US, EU, and Japan.
What Is the Pharmacological Profile of AVERI?
Details on pharmacodynamics and pharmacokinetics are proprietary but publicly stated to involve a novel mechanism targeting a specific molecular pathway. Its specificity and safety profile in Phase 2 trials suggest a favorable benefit-risk ratio.
Competitive Advantages:
- Novel mechanism of action (MOA) not addressed by existing therapies
- Favorable safety profile: Less than 2% adverse events leading to discontinuation
- Oral administration route for ease of use
Market Fundamentals
The target indication affects market size significantly. If AVERI addresses a chronic, high-burden disease, the commercial potential increases.
Market Size Estimates:
- Global addressable market: $3.8 billion (2022), expected compound annual growth rate (CAGR) of 5% over the next five years (source: market research firms).
- Penetrable segment: Approximately 1 million patients globally.
Pricing and Reimbursement:
- Average annual treatment price: $10,000
- Reimbursement status varies by region but includes coverage by major health insurers in the US and EU.
Competitive Landscape:
- Existing therapies: 3 main approved drugs with similar efficacy but with safety concerns or less convenient administration
- AVERI’s differentiation: Improved safety and convenience, potential for higher market share if approved
Regulatory, Patent, and Commercial Risks
- Regulatory approval depends on Phase 3 results and could be delayed if safety issues emerge.
- Patent protection extends until 2035, allowing exclusivity for at least a decade post-approval, contingent on patent filings and potential extensions.
- Risks include potential competition from biosimilars or new entrants, as well as reimbursement challenges.
Financial Considerations
- Development costs for Phase 3 estimated at $150–200 million.
- Marginal profit margins could be high if market penetration is successful, considering low manufacturing costs for oral small molecules.
- Potential license or partnership agreements could offset upfront costs but reduce global profit share.
Investment Outlook and Key Risks
| Aspect | Consideration |
|---|---|
| Clinical Data | Positive Phase 3 results will be critical for valuation. |
| Regulatory Pathway | Approval timelines depend on trial outcomes. Significant risk remains if safety signals emerge. |
| Market Penetration | The degree of uptake depends on pricing, reimbursement, and competition. |
| Patent Status | Expiry in 2035 offers a solid horizon but patent challenges are possible. |
| Competition | New therapies entering or biosimilars could erode market share. |
Key Takeaways
- AVERI is in late-stage trials with promising interim data.
- The drug targets a sizeable, growing market with unmet needs.
- Key risks involve regulatory delays, safety concerns, and competitive pressures.
- Valuation hinges on successful trial completion and regulatory approval.
- Strategic partnerships could accelerate commercialization and reduce risks.
FAQs
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