TIPRANAVIR - Generic Drug Details

What are the generic sources for tipranavir and what is the scope of freedom to operate?

Tipranavir is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for tipranavir. One supplier is listed for this compound.

Summary for TIPRANAVIR

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	68
Patent Applications:	7,080
What excipients (inactive ingredients) are in TIPRANAVIR?	TIPRANAVIR excipients list
DailyMed Link:	TIPRANAVIR at DailyMed

Recent Clinical Trials for TIPRANAVIR

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

Sponsor	Phase
Cairo University	N/A
Aswan Heart Centre	N/A
Rockefeller University	Phase 4

See all TIPRANAVIR clinical trials

Pharmacology for TIPRANAVIR

Drug Class	Protease Inhibitor
Mechanism of Action	HIV Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TIPRANAVIR

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for TIPRANAVIR

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

Expired US Patents for TIPRANAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	APTIVUS	tipranavir	CAPSULE;ORAL	021814-001	Jun 22, 2005
Boehringer Ingelheim	APTIVUS	tipranavir	SOLUTION;ORAL	022292-001	Jun 23, 2008
Boehringer Ingelheim	APTIVUS	tipranavir	CAPSULE;ORAL	021814-001	Jun 22, 2005
Boehringer Ingelheim	APTIVUS	tipranavir	SOLUTION;ORAL	022292-001	Jun 23, 2008
Boehringer Ingelheim	APTIVUS	tipranavir	SOLUTION;ORAL	022292-001	Jun 23, 2008
Boehringer Ingelheim	APTIVUS	tipranavir	CAPSULE;ORAL	021814-001	Jun 22, 2005

EU/EMA Drug Approvals for TIPRANAVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Aptivus	tipranavir	EMEA/H/C/000631 Aptivus, 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

Market Dynamics and Financial Trajectory for Tipranavir

Introduction

Tipranavir, marketed under the brand name Aptivus, is a non-peptidic HIV-1 protease inhibitor used in the treatment of HIV-1 infected patients who have evidence of viral replication and are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors. Here, we delve into the market dynamics and financial trajectory of tipranavir.

Mechanism and Clinical Use

Tipranavir works by inhibiting the processing of the viral Gag and Gag-Pol polyproteins in HIV-1 infected cells, preventing the formation of mature virions. It is co-administered with low-dose ritonavir to enhance its pharmacokinetic properties[5].

Market Size and Growth

The global tipranavir market is expected to grow, albeit at a moderate pace. The market size is projected to increase at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent by 2031, indicating a steady but not rapid expansion[1].

Competitive Landscape

Tipranavir operates in a competitive antiretroviral therapy market dominated by other HIV treatments. For instance, Gilead Sciences' Biktarvy and Descovy have shown significant market share and growth, highlighting the competitive nature of the HIV treatment market[3].

Financial Performance

The financial performance of tipranavir is influenced by several factors, including market demand, pricing dynamics, and competition from other antiretroviral therapies.

Revenue Trends

While specific revenue figures for tipranavir are not readily available, the overall HIV treatment market has seen fluctuations. For example, Gilead Sciences' HIV product sales increased by 5% in 2022, driven by higher demand and favorable pricing dynamics for drugs like Biktarvy and Descovy. However, this growth is not necessarily reflective of tipranavir's performance, as it targets a more niche market of highly treatment-experienced patients[3].

Pricing and Accessibility

Tipranavir is priced competitively within the antiretroviral market. For instance, the cost of Aptivus 250 mg capsules can range from $10 to $15 per capsule, depending on the region and availability. The pricing strategy is crucial in maintaining market share, especially in a market where generic and biosimilar options are becoming more prevalent[5].

Clinical Trials and Regulatory Approvals

Tipranavir has undergone several clinical trials to assess its efficacy and safety. A post-marketing surveillance study evaluated the long-term efficacy and safety of tipranavir co-administered with low-dose ritonavir, which has helped in maintaining its regulatory approvals and market presence[2].

Market Challenges

Despite its unique mechanism of action and clinical utility, tipranavir faces several market challenges:

Competition from New Therapies

The HIV treatment landscape is evolving with the introduction of new therapies, such as long-acting agents like lenacapavir. These innovations can potentially shift market share away from established drugs like tipranavir[3].

Resistance and Side Effects

Tipranavir's efficacy can be compromised by the development of resistance, and it also comes with a range of side effects, including thirst, hunger, unexplained weight loss, and dry, itchy skin. These factors can impact patient adherence and overall market demand[5].

Regulatory and Pricing Pressures

Regulatory pressures and pricing dynamics can significantly affect the financial trajectory of tipranavir. For example, changes in healthcare policies or reimbursement rates can influence the drug's accessibility and affordability[5].

Future Outlook

The future outlook for tipranavir is mixed. While it maintains a niche in treating highly treatment-experienced patients, its growth is likely to be modest due to the competitive landscape and the emergence of new therapies.

Market Expansion

There are opportunities for market expansion, particularly in regions with high HIV prevalence and limited access to newer antiretroviral therapies. However, this would require strategic marketing and distribution efforts.

Research and Development

Continued research and development are crucial for maintaining tipranavir's relevance. This includes exploring new formulations, combination therapies, and addressing resistance issues to enhance its efficacy and safety profile[2].

Key Takeaways

• Moderate Growth: The tipranavir market is expected to grow at a CAGR of 3 to 5 percent by 2031.
• Competitive Market: Tipranavir operates in a competitive HIV treatment market dominated by other antiretroviral therapies.
• Pricing Dynamics: Pricing strategies are critical in maintaining market share and accessibility.
• Clinical Trials: Ongoing clinical trials are essential for evaluating efficacy and safety.
• Market Challenges: Competition from new therapies, resistance issues, and side effects are significant challenges.

FAQs

What is tipranavir used for?

Tipranavir is used for the combination antiretroviral treatment of HIV-1 infected adult patients who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors[5].

How does tipranavir work?

Tipranavir inhibits the processing of the viral Gag and Gag-Pol polyproteins in HIV-1 infected cells, preventing the formation of mature virions. It is co-administered with low-dose ritonavir[5].

What are the common side effects of tipranavir?

Common side effects include thirst, hunger, unexplained weight loss, increased urination, fatigue, and dry, itchy skin[5].

Is tipranavir available in generic form?

As of the latest information, tipranavir is not widely available in generic form, but its patent status suggests that generic options may become available in the future[5].

How does tipranavir compare to other HIV treatments?

Tipranavir targets a niche market of highly treatment-experienced patients and is often used when other protease inhibitors have failed. It competes with other antiretroviral therapies like Biktarvy and Descovy, which have broader market appeal[3].

Sources

1. Global Tipranavir Market Size and Forecast 2 - Market Research Intellect
2. Tipranavir - Drug Targets, Indications, Patents - Patsnap Synapse
3. Gilead Sciences Announces Fourth Quarter and Full Year 2022 Financial Results - Gilead Sciences
4. Tipranavir Market Report 2024 (Global Edition) - Cognitive Market Research
5. Tipranavir: Uses, Interactions, Mechanism of Action - DrugBank Online