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:	61
Clinical Trials:	7
Patent Applications:	6,285
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

Expired US Patents for APTIVUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	APTIVUS	tipranavir	SOLUTION;ORAL	022292-001	Jun 23, 2008	5,852,195*PED
Boehringer Ingelheim	APTIVUS	tipranavir	CAPSULE;ORAL	021814-001	Jun 22, 2005	5,852,195*PED
Boehringer Ingelheim	APTIVUS	tipranavir	SOLUTION;ORAL	022292-001	Jun 23, 2008	6,169,181*PED
Boehringer Ingelheim	APTIVUS	tipranavir	SOLUTION;ORAL	022292-001	Jun 23, 2008	6,147,095*PED
Boehringer Ingelheim	APTIVUS	tipranavir	CAPSULE;ORAL	021814-001	Jun 22, 2005	6,231,887*PED

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/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

International Patents for APTIVUS

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

Country	Patent Number	Title	Estimated Expiration
Japan	2010070562	SELF-EMULSIFYING FORMULATION FOR LIPOPHILIC COMPOUND
Czech Republic	20000156
China	1749252
Slovakia	284579
China	1324237

Supplementary Protection Certificates for APTIVUS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0758327	SPC034/2005	Ireland		SPC034/2005: 20061023, EXPIRES: 20200503
0758327	PA2005008,C0758327	Lithuania		PRODUCT NAME: TIPRANAVIRUM; REGISTRATION NO/DATE: EU/1/05/315/001 20051025
0758327	91220	Luxembourg		91220, EXPIRES: 20200504
0758327	05C0047	France		PRODUCT NAME: TIPRANAVIR; 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 Experimental

Market Dynamics and Financial Trajectory of HIV Drugs: A Focus on the Global Market

Introduction

The global HIV drugs market is a complex and dynamic sector driven by various factors, including the prevalence of HIV, advancements in treatment, government initiatives, and market competition. This article will delve into the market dynamics and financial trajectory of HIV drugs, with a particular emphasis on the broader market context.

HIV Drugs Market Overview

The global HIV drugs market was valued at $32.8 billion in 2022 and is projected to reach $51.1 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 4.5% from 2023 to 2032[1].

Market Drivers

Several key factors drive the growth of the HIV drugs market:

Rise in HIV Prevalence

The increasing number of people living with HIV globally is a significant driver. According to UNAIDS, 39 million people were living with HIV in 2022, with 1.3 million new infections and 630,000 AIDS-related deaths in the same year[1].

Government Initiatives

Government and international organizations' efforts to raise awareness and improve diagnosis and management of HIV contribute to the market's growth. Initiatives aimed at reducing the stigma associated with HIV and increasing access to antiretroviral therapy (ART) are crucial[1].

Advancements in Treatment

The development of multi-class combination drugs and other advanced therapies has improved treatment outcomes, increasing demand for these drugs. The multi-class combination drugs segment held the largest share in the HIV drugs market in 2022[1].

Market Segmentation

By Medication Class

The market is segmented into various medication classes, including Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), HIV Integrase Strand Transfer Inhibitors (INSTIs), and others. Each class has its own growth trajectory based on efficacy, safety, and patient compliance[4].

By Distribution Channel

Hospital pharmacies dominated the HIV drugs market in 2022 due to high sales and a large number of HIV patients seeking treatment in hospitals. However, online pharmacies are expected to witness the highest CAGR during the forecast period due to convenience, improved logistics, and attractive discounts[1].

Regional Analysis

North America

North America accounted for the largest market share in 2022, driven by the presence of major players like AbbVie Inc., Bristol-Myers Squibb Company, Gilead Sciences, Inc., Johnson & Johnson, and Merck & Co., Inc. The region's advanced healthcare facilities, high healthcare expenditure, and sophisticated reimbursement structure also contribute to its dominance[1].

Asia-Pacific

The Asia-Pacific region is expected to grow at the highest rate during the forecast period. Countries like China and India, with large populations and increasing purchasing power, drive this growth. The focus of key players on emerging economies and the rising incidence of HIV infections in these regions further boost the market[1].

Financial Trajectory

Market Size and Growth

The global HIV drugs market is expected to grow from $32.8 billion in 2022 to $51.1 billion by 2032, with a CAGR of 4.5%. This growth is driven by the increasing demand for HIV drugs, government initiatives, and advancements in treatment options[1].

Revenue and Sales

The revenue growth in the HIV drugs market is also influenced by the sales channels. Hospital pharmacies, while currently dominant, are expected to see a rise in competition from online pharmacies due to their convenience and cost-effectiveness[1].

Key Players

The market is highly competitive, with several key players such as Merck & Co., Inc., GlaxoSmithKline plc, Bristol-Myers Squibb Company, F. Hoffmann-La Roche Ltd., Johnson & Johnson, Gilead Sciences, Inc., AbbVie Inc., Cipla Ltd., Teva Pharmaceutical Industries Ltd., and Boehringer Ingelheim International GmbH. These companies invest heavily in research and development to bring innovative treatments to the market[1].

Competition Analysis

The competition in the HIV drugs market is intense, with companies focusing on developing multi-class combination drugs and improving existing therapies. The insights from top-level executives indicate that the market is expected to grow significantly due to the surge in HIV cases and the need for effective treatments[1].

Market Challenges

Cost and Accessibility

One of the significant challenges is the high cost of HIV drugs, which can be a barrier to access, especially in low-income countries. However, the increased use of generics and government initiatives to reduce costs are helping to mitigate this issue[1].

Regulatory Environment

The regulatory environment plays a crucial role in the HIV drugs market. Strict regulations and the need for extensive clinical trials can slow down the approval process for new drugs. However, regulatory bodies are also working to streamline the process to ensure timely access to effective treatments[4].

Future Outlook

Emerging Trends

The future of the HIV drugs market is promising, with emerging trends such as the development of long-acting antiretroviral therapies and the integration of digital health technologies to improve patient adherence and outcomes[4].

Regional Growth

Asia-Pacific is expected to emerge as a significant growth region due to its large population base and increasing healthcare expenditure. The focus of key players on emerging economies will drive the market growth in this region[1].

Key Takeaways

• The global HIV drugs market is projected to reach $51.1 billion by 2032, growing at a CAGR of 4.5%.
• The multi-class combination drugs segment holds the largest market share.
• Hospital pharmacies currently dominate the market, but online pharmacies are expected to grow significantly.
• North America is the largest market, but Asia-Pacific will witness the highest growth rate.
• Key players are investing heavily in R&D to develop innovative treatments.

FAQs

What is the current size of the global HIV drugs market?

The global HIV drugs market was valued at $32.8 billion in 2022[1].

What is the expected growth rate of the global HIV drugs market?

The market is expected to grow at a CAGR of 4.5% from 2023 to 2032[1].

Which region is expected to witness the highest growth rate in the HIV drugs market?

The Asia-Pacific region is expected to witness the highest growth rate during the forecast period[1].

What are the main drivers of the HIV drugs market?

The main drivers include the rise in HIV prevalence, government initiatives, and advancements in treatment options[1].

Who are the key players in the HIV drugs market?

Key players include Merck & Co., Inc., GlaxoSmithKline plc, Bristol-Myers Squibb Company, F. Hoffmann-La Roche Ltd., Johnson & Johnson, Gilead Sciences, Inc., AbbVie Inc., Cipla Ltd., Teva Pharmaceutical Industries Ltd., and Boehringer Ingelheim International GmbH[1].

Sources

1. Allied Market Research: "HIV Drugs Market Size, Share and Growth Analysis | Report, 2032"
2. Aptiv: "Aptiv Reports Fourth Quarter 2023 Financial Results" (Note: This source is not directly relevant to the HIV drugs market but was included in the search results.)
3. Law Project for Psychiatric Rights: "R E P O R T - Market dynamics. NATIONAL DRUG TREND."
4. GlobeNewswire: "Outlook on the HIV Drugs Global Market to 2027 - Opportunity Analysis and Industry Forecast"