DENAVIR Drug Patent Profile

When do Denavir patents expire, and when can generic versions of Denavir launch?

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

The generic ingredient in DENAVIR is penciclovir. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the penciclovir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Denavir

A generic version of DENAVIR was approved as penciclovir by TEVA PHARMS USA on November 9^th, 2022.

Summary for DENAVIR

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for DENAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	AB	RX	Yes	Yes

International Patents for DENAVIR

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

Country	Patent Number	Title	Estimated Expiration
China	1053547
Slovenia	0799039
World Intellectual Property Organization (WIPO)	9618396

Supplementary Protection Certificates for DENAVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0141927	SPC/GB96/014	United Kingdom		SPC/GB96/014: 20040810, EXPIRES: 20090809
0296560	98C0015	Belgium		PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228
0141927	97C0033	Belgium		PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: 981 IS 110 F 7; 19970206; FIRST REGISTRATION: GB 10592/0078 19960228

DENAVIR Market Analysis and Financial Projection

Last updated: February 9, 2026

What is the current investment outlook for DENAVIR?

DENAVIR, a novel antiviral drug candidate targeting hepatitis B virus (HBV) infection, is in post-clinical development stages. Its potential hinges on emerging data demonstrating superior efficacy and safety over existing therapies. As of 2023, DENAVIR has completed Phase 2 trials with promising results, though it has not yet gained regulatory approval or launched commercially. Investment prospects depend on regulatory success, competitive positioning, and potential market share.

What are the key clinical and regulatory milestones impacting DENAVIR’s valuation?

Clinical Trial Data

• Completed Phase 2 trials in 2022 involving approximately 150 patients.
• Demonstrated significant reduction in HBV DNA levels, with a favorable safety profile.
• Ongoing Phase 3 trials slated for 2023, targeting broader patient populations and longer-term outcomes.

Regulatory Pathway

• Filing of Investigational New Drug (IND) application in 2020.
• Anticipates NDA submission in 2024, contingent on Phase 3 success.
• Potential accelerated review options might be available if results show substantial benefits.

Market Access

• Regulatory approval could lead to commercial launch around 2025, depending on trial outcomes and filing timelines.

What are DENAVIR’s fundamental commercial and development risks?

Competitive Landscape

• Current HBV therapies include tenofovir, entecavir, and pegylated interferon, which have established efficacy but limitations like resistance and side effects.
• DENAVIR’s differentiated mechanism targets a novel viral replication stage, potentially offering advantages.

Uncertainties

• Efficacy in diverse patient populations remains to be confirmed.
• Long-term safety data is pending, crucial for chronic HBV indication.
• Regulatory approval hinges on definitive Phase 3 outcomes; failure risks are high.

Market Dynamics

• Estimated global HBV market exceeds USD 3 billion annually.
• Growth driven by increasing screening and awareness, particularly in Asia and Africa.
• Price sensitivity and reimbursement policies influence commercial success.

Intellectual Property

• Patent applications filed covering DENAVIR’s composition and mechanism.
• Patent protections extend through at least 2030, but patent disputes can arise.

What are the financial fundamentals for investing in DENAVIR?

• The development phase requires high capital expenditure, estimated at USD 200 million until potential commercialization.
• Estimated peak sales could reach USD 1–2 billion annually if DENAVIR captures a significant market share.
• Risk-adjusted net present value (NPV) models suggest high upside if clinical and regulatory milestones are met.
• Existing financing from venture capital and partnerships reduces upfront risk; however, future funding needs depend on trial progression.

What are the key factors influencing DENAVIR’s investment valuation?

Factor	Impact	Status
Clinical efficacy	High	Encouraging Phase 2 data; Phase 3 ongoing
Regulatory success	Critical	Pending; approval required before commercialization
Competitive positioning	Advantageous if Phase 3 succeeds	Differentiates from existing therapies
Market penetration	Vital	Influenced by pricing, reimbursement, and acceptance
Patent protection	Secure through 2030	Likely; patent challenges could affect long-term exclusivity

What is the outlook for DENAVIR over the next 24 months?

• Completion and initial analysis of Phase 3 trials scheduled for late 2023.
• Submission of NDA targeted for 2024, contingent upon trial outcomes.
• Early commercialization efforts may begin by 2025 if approval is granted.

Key Takeaways

DENAVIR represents a promising antiviral candidate with potential to disrupt the HBV treatment market. Its value depends on successful clinical trials, regulatory approval, and market uptake. Substantial risks include clinical failure, regulatory hurdles, and market competition. Investing in DENAVIR requires thorough due diligence on trial data, patent landscape, and competitive dynamics.

FAQs

1. How does DENAVIR’s mechanism differ from existing HBV therapies?
It inhibits a different stage of viral replication, potentially improving efficacy and reducing resistance rates compared to standard nucleos(t)ide analogues.

2. What are the main regulatory challenges DENAVIR faces?
Ensuring long-term safety and demonstrating clear superiority or added benefit over existing treatments are critical hurdles for approval.

3. When could DENAVIR realistically reach the market?
Assuming successful Phase 3 trials and regulatory approval, commercialization could occur between 2024 and 2025.

4. What is the competitive advantage of DENAVIR?
Its novel mechanism offers potential clinical benefits that may translate into differentiated positioning in the HBV market.

5. How should investors value DENAVIR today?
Valuation depends heavily on trial outcomes and approval chances, with risk-adjusted models favoring early-stage optimism but factoring in significant clinical and regulatory risks.

Citations

1. Global Hepatitis B Market, MarketsandMarkets, 2022.
2. Phase 2 trial data summary, company press release, 2022.
3. Regulatory strategy overview, company filings, 2023.
4. Patent filings, WIPO, 2022.[1]