AGENERASE Drug Patent Profile

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

Agenerase is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in AGENERASE is amprenavir. There are five drug master file entries for this compound. Additional details are available on the amprenavir profile page.

Summary for AGENERASE

US Patents:	0
Applicants:	1
NDAs:	2

US Patents and Regulatory Information for AGENERASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	AGENERASE	amprenavir	CAPSULE;ORAL	021007-001	Apr 15, 1999		DISCN	No	No
Glaxosmithkline	AGENERASE	amprenavir	CAPSULE;ORAL	021007-002	Apr 15, 1999		DISCN	No	No
Glaxosmithkline	AGENERASE	amprenavir	SOLUTION;ORAL	021039-001	Apr 15, 1999		DISCN	Yes	No

International Patents for AGENERASE

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

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	390	Novel sulfonamide inhibitors aspartyl protease.
African Regional IP Organization (ARIPO)	9300572
African Regional IP Organization (ARIPO)	950	THF-containing sulfonamide inhibitors of aspartyl protease.

Supplementary Protection Certificates for AGENERASE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0659181	SPC004/2001	Ireland		SPC004/2001: 20050808, EXPIRES: 20140511
0933372	08C0015	France		PRODUCT NAME: FOSAMPRENAVIR CALCIQUE; REG. NO/DATE: EU/1/07/282/001-002 20040712
0659181	5/2001	Austria		PRODUCT NAME: AMPRENAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/00/148/001 - EU/1/00/148/004 20001020; FIRST REGISTRATION: LI 55072 01, 55072 02 UND 55073 01 19990512

Last updated: February 9, 2026

Investment Scenario and Fundamentals Analysis for AGENERASE

What is AGENERASE?

Agenerase is the brand name for amprenavir, an HIV-1 protease inhibitor. It is used in combination therapy for treating HIV/AIDS. The drug was developed by GlaxoSmithKline (GSK) and approved by the FDA in 1999. Its key role involves inhibiting the HIV protease enzyme, which is crucial for viral replication.

Market Position and Competitive Landscape

The HIV treatment market is mature, with drugs such as efavirenz, darunavir, and integrase inhibitors like raltegravir dominating. AGENERASE's market share has declined due to the advent of newer agents with improved safety profiles and administration convenience.

• Peak sales: Estimated $600 million globally in late 2000s.
• Current sales: Estimated below $50 million; GSK has largely phased out or discontinued sale in many markets.

In 2013, GSK discontinued supplies of amprenavir in the U.S., focusing on newer therapies. Off-label use persists in some regions, but it lacks significant growth potential.

Patent and Regulatory Status

• Patents: U.S. patents expired in 2012; international patents varied, ending between 2012-2015.
• Regulatory exclusivity: No major exclusivity remaining, diminishing potential for new sales or licensing.
• Generic presence: Multiple generics available, driving pricing pressure.

R&D and Lifecycle Considerations

Though no recent clinical development or pipeline activity is linked with AGENERASE, its position as a therapy largely replaced by safer, more effective drugs makes further R&D unlikely.

• Off-label potential: Limited, due to safety concerns and availability of superior therapies.
• Lifecycle extension: Unlikely, given patent expiry and market erosion.

Investment Fundamentals

• Revenue outlook: Diminishing, with current annual sales estimated below $50 million.
• Profit margins: Likely negative or minimal, given low sales volume and generic competition.
• Regulatory risk: Low; the drug's approval status remains valid, but market risk is high.
• Market growth: Flat or declining, with no clear recovery trajectory.
• Competitive risks: High; newer drugs outpace amprenavir in efficacy and tolerability.

Strategic Considerations

Investors should view AGENERASE as a legacy product with diminishing relevance. It offers limited strategic value unless linked with emerging formulations or combination therapies, which are unlikely given current market trends.

Regulatory and Legal Risks

Regulatory barriers are minimal due to product approval status. Litigation risks are negligible, primarily revolving around patent disputes which have already resolved.

Financial Impact

The drug's declining sales minimize its influence on GSK’s overall financials. Any residual value stems from inventory or potential licensing deals, which are unlikely to produce substantive income.

Conclusion

AGENERASE presents a declining asset with minimal near-term commercial prospects. Investment interest should focus elsewhere unless new indications or formulations re-emerge, which current data does not support.

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Key Takeaways

• The drug's patent expiries and market erosion make future sales prospects negligible.
• Market dominance has shifted to newer, better-tolerated HIV drugs.
• Low sales volume and increasing competition render AGENERASE unsuitable for strategic investment.
• The drug has no active pipeline or significant regulatory hurdles but faces obsolescence risks.
• Financial impact remains minimal; prospects do not justify new investment.

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Frequently Asked Questions

1. Is there any potential for AGENERASE to be revived in the market?
No. The drug faces patent expiration, generic competition, and alternative therapies with better profiles, reducing likelihood of revival.

2. Are there ongoing clinical trials involving AGENERASE?
No recent or ongoing clinical trials are publicly documented or reported to be in development.

3. Could licensing or license sales provide value?
Possible but unlikely to produce meaningful returns given extensive generic competition and market decline.

4. What are the main barriers to continued sales?
Patents have expired, newer therapies outperform AGENERASE in safety and efficacy, and at least multiple generics suppress pricing.

5. Should investors consider M&A activity involving legacy HIV drugs?
Yes, but AGENERASE is not a focus given its obsolescence; attention should be on pipeline assets or drugs with growth potential.

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References

1. U.S. Food and Drug Administration (FDA). Product Approval Information for Amprenavir. 1999.
2. GlaxoSmithKline Annual Reports. 2010-2020.
3. IQVIA Reports. HIV Market Data, 2022.
4. PhRMA. Market Trends in HIV Treatment. 2021.
5. Patent databases (USPTO, EPO). Patent expiration dates for amprenavir. 2012-2015.