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
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	3
Patent Applications:	5,654
DailyMed Link:	AGENERASE at DailyMed

Recent Clinical Trials for AGENERASE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Institutes of Health (NIH)	Phase 2/Phase 3
National Institute of Mental Health (NIMH)	Phase 2/Phase 3
University of California, San Diego	Phase 2/Phase 3

See all AGENERASE clinical trials

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

Expired US Patents for AGENERASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	AGENERASE	amprenavir	CAPSULE;ORAL	021007-002	Apr 15, 1999	5,585,397
Glaxosmithkline	AGENERASE	amprenavir	CAPSULE;ORAL	021007-002	Apr 15, 1999	5,646,180
Glaxosmithkline	AGENERASE	amprenavir	CAPSULE;ORAL	021007-001	Apr 15, 1999	5,585,397
Glaxosmithkline	AGENERASE	amprenavir	CAPSULE;ORAL	021007-002	Apr 15, 1999	5,723,490
Glaxosmithkline	AGENERASE	amprenavir	SOLUTION;ORAL	021039-001	Apr 15, 1999	5,723,490
Glaxosmithkline	AGENERASE	amprenavir	CAPSULE;ORAL	021007-001	Apr 15, 1999	5,723,490
Glaxosmithkline	AGENERASE	amprenavir	CAPSULE;ORAL	021007-001	Apr 15, 1999	6,730,679

EU/EMA Drug Approvals for AGENERASE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Glaxo Group Ltd.	Agenerase	amprenavir	EMEA/H/C/000264Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years. Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5). The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).The benefit of Agenerase boosted with ritonavir has not been demonstrated in PI nave patients (see section 5.1)	Withdrawn	no	no	no	2000-10-20

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.
African Regional IP Organization (ARIPO)	9701119
Austria	178598
Austria	222761
Austria	241602

Supplementary Protection Certificates for AGENERASE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0659181	CA 2001 00007	Denmark
0659181	SPC004/2001	Ireland		SPC004/2001: 20050808, EXPIRES: 20140511
0659181	SPC/GB01/009	United Kingdom		PRODUCT NAME: AMPRENAVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR DERIVATIVE; REGISTERED: CH 5507201 19990512; CH 5507202 & 5507301 19990512; UK EU/1/00/148/001 20001020; UK EU/1/00/148/002 20001020; UK EU/1/001/148/003 20001020; UK EU/1/00/148/004 20001020
0659181	2001C/014	Belgium		PRODUCT NAME: AMPRENAVIR; NATL. REGISTRATION NO/DATE: EU/1/00/148/001 20001020; FIRST REGISTRATION: CH 55072 01 19990512
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
0933372	PA2008006	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0933372	PA2008006,C0933372	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712

Market Dynamics and Financial Trajectory for AGENERASE

Last updated: February 20, 2026

What is the current market landscape for AGENERASE?

AGENERASE (amprenavir) is an antiretroviral drug used in HIV-1 treatment. Originally marketed by GlaxoSmithKline (GSK), its market presence has declined due to patent expirations, generic competition, and evolving HIV treatment protocols. As of 2023, the drug faces limited demand in comparison with newer therapies.

The global HIV pharmacotherapy market was valued at approximately $30 billion in 2022. Protease inhibitors (PIs) like AGENERASE hold a subsegment, with an estimated market share of 2–3%. The shift of treatment guidelines towards integrase inhibitors (e.g., Dolutegravir) reduces AGENERASE's relevance.

How has the patent and regulatory landscape affected AGENERASE?

The original patent for AGENERASE expired in the US in 2014. GSK's patent protections prevented generics during the patent term, but generic options entered markets subsequently. For example:

• The US patent expiration was in 2014; generic versions entered in 2015.
• The European patent expired in 2014, leading to immediate generic competition.

There have been no recent regulatory re-approvals or new formulations. GSK shifted focus away from AGENERASE after 2016, aligning with gradual market exit.

What are the financial trends associated with AGENERASE?

Revenue for AGENERASE has significantly declined since patent expiration:

Year	Estimated Sales (USD millions)	Market Share (Protease inhibitors segment)
2014	50	0.8%
2015	20	0.3%
2018	5	0.1%
2022	1	Less than 0.1%

Market contraction is driven by:

• Generic competition reducing prices below $10 per 300 mg tablet.
• Shifts in treatment guidelines favoring less toxic, more convenient drugs.
• Decreased prescriber familiarity and preference for newer regimens.

What are the outlook projections for AGENERASE?

The trajectory indicates continued decline:

• No recent regulatory approvals or novel formulations.
• Likely market disappearance outside niche or research applications.
• Potential for minor residual sales in emerging markets with limited patent enforcement.

Forecasts suggest negligible revenues (<$1 million annually) by 2025, largely dependent on existing stock and off-label use.

How do external factors influence its market trajectory?

Supply chain issues, patent litigation, and policy shifts impact generic markets:

• Patent litigation has largely resolved, with generic entry rapid post-expiration.
• Regulatory agencies prioritize innovative therapies, reducing incentives for drug repurposing.
• Market access constraints in low-income regions depend on local patent laws and generic availability.

What is GSK’s strategic position regarding AGENERASE?

GSK withdrew AGENERASE from most markets post-2016. Remaining assets are primarily in legacy supply or research:

• The company no longer invests in marketing or regulatory support.
• Focus has shifted toward HIV agents with higher efficacy and better safety profiles.
• AGENERASE’s financial contribution is negligible; its strategic value has phased out.

Summary

AGENERASE's market has shrunk from a niche protease inhibitor to a largely obsolete product within five years of patent expiration. Its financial impact has diminished to near-zero levels. The drug's future largely depends on generic supply chains and regulatory environments in specific regions.

Key Takeaways

• AGENERASE faced rapid market decline following patent expiration in 2014 with generic entries in 2015.
• Current revenues are estimated below $1 million annually, with no recent improvements.
• Market trends favor newer HIV therapies, further reducing AGENERASE's relevance.
• GSK exited most markets and shifted focus away from this drug since 2016.
• The outlook indicates continued obsolescence, with tiny residual markets remaining.

FAQs

1. Has AGENERASE been reformulated or reapproved since patent expiry?
No. There have been no recent reformulations or regulatory reapprovals.

2. Will generic versions of AGENERASE dominate future markets?
Yes. Generic versions have already replaced branded sales in most regions.

3. Are there any ongoing research uses for AGENERASE?
Limited, primarily in pharmacological studies; no significant clinical development.

4. Can AGENERASE regain market share through new indications?
Unlikely. No new indications or reformulations are planned, and the market prefers newer drugs.

5. How does AGENERASE compare financially with newer HIV drugs?
It is negligible. Current revenues are minuscule compared to billions generated annually by drugs like Dolutegravir or Biktarvy.

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References

1. MarketResearch.com. (2023). Global HIV pharmacotherapy market analysis.
2. GSK Annual Report 2016. (2016). Portfolio updates and product discontinuations.
3. U.S. Food and Drug Administration. (2022). Drug expiration and generic approval timelines.
4. IQVIA. (2022). Global HIV treatment market share report.
5. World Health Organization. (2022). HIV treatment guidelines update.