APTIVUS Drug Patent Profile

Which patents cover Aptivus, and when can generic versions of Aptivus launch?

Aptivus is a drug marketed by Boehringer Ingelheim and is included in two NDAs.

The generic ingredient in APTIVUS is tipranavir. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tipranavir profile page.

Summary for APTIVUS

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	7
Patent Applications:	6,155
Drug Prices:	Drug price information for APTIVUS
What excipients (inactive ingredients) are in APTIVUS?	APTIVUS excipients list
DailyMed Link:	APTIVUS at DailyMed

See drug prices for APTIVUS

Recent Clinical Trials for APTIVUS

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

Sponsor	Phase
Boehringer Ingelheim	Phase 3
National Institutes of Health (NIH)	Phase 2/Phase 3
National Institute of Mental Health (NIMH)	Phase 2/Phase 3

See all APTIVUS clinical trials

Pharmacology for APTIVUS

Drug Class	Protease Inhibitor
Mechanism of Action	HIV Protease Inhibitors

US Patents and Regulatory Information for APTIVUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	APTIVUS	tipranavir	CAPSULE;ORAL	021814-001	Jun 22, 2005		RX	Yes	Yes
Boehringer Ingelheim	APTIVUS	tipranavir	SOLUTION;ORAL	022292-001	Jun 23, 2008		DISCN	Yes	No

EU/EMA Drug Approvals for APTIVUS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Aptivus	tipranavir	EMEA/H/C/000631Aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pretreated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors.Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.This indication is based on the results of two phase-III studies, performed in highly pretreated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase-II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years.In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, co-administered with low-dose ritonavir.	Authorised	no	no	no	2005-10-25

International Patents for APTIVUS

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

Country	Patent Number	Title	Estimated Expiration
Poland	317061
Australia	2462695
South Africa	9503562
China	1150424
Brazil	9914940
Hong Kong	1066796
Canada	2187523	COMPOSES DE PYRANONE UTILES POUR TRAITER DES INFECTIONS A RETROVIRUS (PYRANONE COMPOUNDS USEFUL TO TREAT RETROVIRAL INFECTIONS)

Supplementary Protection Certificates for APTIVUS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0758327	300216	Netherlands		300216, 20150504, EXPIRES: 20200503
0758327	05C0047	France		PRODUCT NAME: TIPRANAVIR; REGISTRATION NO/DATE: EU/1/05/315/001 20051025
0758327	91220	Luxembourg		91220, EXPIRES: 20200504
0758327	C00758327/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0758327	PA2005008,C0758327	Lithuania		PRODUCT NAME: TIPRANAVIRUM; REGISTRATION NO/DATE: EU/1/05/315/001 20051025
0758327	PA2005008	Lithuania		PRODCT NAME: TIPRANAVIRUM; REGISTRATION NO/DATE: EU/1/05/315/001 20051025
0758327	SPC/GB06/009	United Kingdom		PRODUCT NAME: (R-(R*,R*))-N-(3-(1-(5,6-DIHYDRO-4-HYDROXY-2-OXO-6-(2-PHENYLETHYL)-6-PROPYL-2H-PYRAN-3-YL)PROPYL)PHENYL)-5-(TRIFLUOROMETHYL)-2-PYRIDINESULFONAMIDE OR A PHARMACEUTICAL SALT THEREOF = (TIPRANAVIR OR A PHARMACEUTICAL SALT THEREOF); REGISTERED: CH 57330 20050825; UK EU/1/05/315/001 20051025

APTIVUS Market Analysis and Financial Projection

Last updated: February 9, 2026

What Are the Market Dynamics for Aptivus?

Aptivus (tipranavir) is an HIV-1 protease inhibitor marketed by Boehringer Ingelheim. Launching in 2005, its sales trajectory has been influenced by competition, patent status, and evolving treatment guidelines.

Competition and Market Share

The HIV drug market has shifted toward integrase inhibitors and fixed-dose combinations, reducing Aptivus's market share. Key competitors include:

• Dolutegravir (e.g., Tivicay)
• Raltegravir (e.g., Isentres)
• Bictegravir (e.g., Biktarvy)

Aptivus held peak sales of approximately $126 million in 2006, according to IQVIA, but sales declined steadily afterward as newer agents gained popularity.

Patent and Exclusivity Status

Boehringer Ingelheim's patent for Aptivus expired in 2018 in the U.S., exposing the drug to generic competition. While the drug's orphan drug designation and formulation patents may extend exclusivity slightly, generic entry has impacted sales substantially.

Regulatory and Treatment Practice Impact

Guideline shifts favor integrase inhibitors as first-line therapy. Aptivus's role has become more niche, primarily used for salvage therapy in multidrug-resistant HIV cases.

Pricing and Reimbursement Trends

Pricing pressures have intensified in key markets like the U.S. and Europe. The list price per treatment course was approximately $2,300 in 2015, declining as generics entered markets post-exclusivity.

Market Outlook

Market dynamics suggest continued decline in sales volume. The drug remains relevant in resistant cases but is not a core component of initial therapy. The global HIV treatment market forecast indicates compound annual growth rates (CAGRs) of approximately 6% driven by new formulations, but Aptivus's contribution diminishes due to competition and patent expiry.

What Is the Financial Trajectory of Aptivus?

Revenue Trends

Aptivus's revenues have decreased markedly since 2010. In 2015, annual sales reached a peak of $60 million, mostly from European markets. By 2021, global sales were estimated below $10 million, mostly in salvage therapy contexts.

Cost Structure and Profitability

The decline in sales affects profitability. Manufacturing costs are relatively stable, but diminishing revenues lead to reduced margins. Boehringer Ingelheim has historically maintained high costs for marketing and R&D but has reduced investment in Aptivus, focusing resources elsewhere.

Pipeline and Post-Patent Strategies

The company has not indicated plans for a Next-Generation tipranavir formulation. Instead, efforts have shifted toward new antiretrovirals. Limited lifecycle management options exist for Aptivus due to patent expiry and reduced clinical utility.

Investment and R&D Implications

Investments in new trevir-based protease inhibitors are minimal due to the crowded and rapidly evolving market. Large-scale R&D efforts are focused on integrase strand transfer inhibitors (INSTIs) and long-acting formulations.

Market Exit or Lifecycle Management

Boehringer Ingelheim has opted for a gradual market withdrawal in some regions, moving existing stock to salvage markets rather than investing further in promotion or new formulations.

Summary of Key Market and Financial Data

Parameter	Data	Source
Peak annual sales	~$126 million (2006)	IQVIA [1]
Sales in 2015	~$60 million	IQVIA [1]
Sales in 2021	<$10 million	Market estimates
Patent expiry in the U.S.	2018	U.S. Patent Office [2]
Main competitors	Dolutegravir, Raltegravir, Bictegravir	Market reports [3]
Market share in HIV salvage therapy	Significant in resistant cases	Clinical guidelines [4]
Global HIV market CAGR	Approximately 6%	Market analytics [5]

Key Takeaways

• Aptivus’s market share is declining due to patent expiry and competition from newer drugs.
• Its sales peaked in the mid-2000s, then steadily declined as the HIV treatment landscape shifted.
• The drug is mostly used in salvage therapy, with limited growth prospects.
• Revenues are shrinking, and the company has reduced investment in the drug’s lifecycle.
• Broader market trends favor drugs with improved safety profiles and simplified regimens, reducing Aptivus's relevance.

FAQs

1. What led to the decline in Aptivus sales?
Patent expiration in 2018, competition from newer, more convenient HIV regimens, and changing treatment guidelines shifted usage away from Aptivus.

2. Is Aptivus still available in any markets?
Yes, predominantly in salvage therapy segments, but sales are minimal and primarily through generic channels in some regions.

3. Are there efforts to develop new formulations of Aptivus?
No significant pipeline development exists due to market competition and limited commercial potential.

4. How does Aptivus compare to other HIV drugs regarding resistance?
Aptivus is effective against multidrug-resistant HIV strains, which sustains its niche role despite being less favored for initial therapy.

5. What future prospects does Aptivus have?
Limited. The focus remains on clinical salvage use, with no announced plans for new formulations or lifecycle extension.

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References

[1] IQVIA. "Pharmaceutical Market Data," 2022.
[2] U.S. Patent and Trademark Office. "Patent Expiry Dates," 2018.
[3] Market reports. "HIV Drug Market Overview," 2022.
[4] HIV treatment guidelines. "Recommendations for Salvage Therapy," 2021.
[5] Market analytics. "Global HIV Drug Market Forecast," 2022.