FORTOVASE Drug Patent Profile

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

Fortovase is a drug marketed by Hoffmann La Roche and is included in one NDA.

The generic ingredient in FORTOVASE is saquinavir. There is one drug master file entry for this compound. Additional details are available on the saquinavir profile page.

Summary for FORTOVASE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	8
Patent Applications:	5,400
DailyMed Link:	FORTOVASE at DailyMed

Recent Clinical Trials for FORTOVASE

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

Sponsor	Phase
Saint Michael's Medical Center	Phase 3
Boehringer Ingelheim	Phase 1
Hoffmann-La Roche	Phase 3

See all FORTOVASE clinical trials

US Patents and Regulatory Information for FORTOVASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hoffmann La Roche	FORTOVASE	saquinavir	CAPSULE;ORAL	020828-001	Nov 7, 1997		DISCN	Yes	No

Expired US Patents for FORTOVASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	FORTOVASE	saquinavir	CAPSULE;ORAL	020828-001	Nov 7, 1997
Hoffmann La Roche	FORTOVASE	saquinavir	CAPSULE;ORAL	020828-001	Nov 7, 1997
Hoffmann La Roche	FORTOVASE	saquinavir	CAPSULE;ORAL	020828-001	Nov 7, 1997

EU/EMA Drug Approvals for FORTOVASE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Invirase	saquinavir	EMEA/H/C/000113 Invirase is indicated for the treatment of HIV-1-infected adult patients. Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products.	Withdrawn	no	no	no	1996-10-03
Roche Registration Ltd.	Fortovase	saquinavir	EMEA/H/C/000178 Fortovase is indicated for treatment of HIV-1 infected adult patients. Fortovase should only be given in combination with ritonavir and other antiretroviral medicinal products (see section 4.2).	Withdrawn	no	no	no	1998-08-20

International Patents for FORTOVASE

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

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	47871
Australia	1775100
Iceland	4627
China	1066329
Japan	H03255076	AMINO ACID DERIVATIVE
World Intellectual Property Organization (WIPO)	0028942
European Patent Office	0831826	COMPOSITIONS PHARMACEUTIQUES COMPRENANT UN INHIBITEUR DE PROTEINASES ET UN MONOGLYCERIDE (PHARMACEUTICAL COMPOSITION COMPRISING A PROTEINASE INHIBITOR AND A MONOGLYCERIDE)

Supplementary Protection Certificates for FORTOVASE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432695	32/1996	Austria		PRODUCT NAME: SAQUINAVIR UND SEINE SAEUREADDITIONSSALZE, INSBESONDERE SAQUINAVIRMESYLAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0034432	96C0048	Belgium		PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0432695	C970013	Netherlands		PRODUCT NAME: SAQUINAVIR DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0432695	96C0044	Belgium		PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004

FORTOVASE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FORTOVASE

Introduction

FORTOVASE, a brand of the HIV protease inhibitor saquinavir, was a significant player in the antiretroviral drug market, particularly in the late 1990s and early 2000s. This article delves into the market dynamics and financial trajectory of FORTOVASE, highlighting its pharmacokinetics, market impact, pricing strategies, and the eventual withdrawal from the market.

Pharmacokinetics and Clinical Impact

FORTOVASE was known for its improved bioavailability compared to its predecessor, INVIRASE. The relative bioavailability of saquinavir administered as FORTOVASE was estimated to be 331% higher than when administered as INVIRASE[1][4][5].

Bioavailability and Dosing

The drug exhibited a greater than dose-proportional increase in saquinavir plasma concentrations, especially when administered with a high-fat meal. This led to significantly higher steady-state AUC (Area Under the Curve) values, making it a more effective treatment option for HIV patients[1][4][5].

Interactions with Other Drugs

FORTOVASE's pharmacokinetics were also influenced by coadministered drugs. For example, coadministration with ritonavir significantly increased saquinavir plasma concentrations, while other drugs like clarithromycin and ketoconazole also had notable effects on its pharmacokinetics[1][4].

Market Impact

Introduction and Initial Success

FORTOVASE was introduced as an improvement over INVIRASE, offering better bioavailability and thus enhanced therapeutic efficacy. This led to its rapid adoption in the treatment of HIV, particularly in combination therapies.

Competition and Market Share

The antiretroviral market is highly competitive, with numerous drugs and combinations available. FORTOVASE competed with other protease inhibitors and combination therapies, such as those involving ritonavir and other antiretroviral agents. Despite its advantages, FORTOVASE faced challenges in maintaining market share due to the continuous evolution of antiretroviral therapies[3].

Pricing Strategies and Access

Pharmaceutical Pricing Dynamics

The pricing of FORTOVASE, like other antiretroviral drugs, was influenced by various factors including research and development costs, regulatory environments, and market demand. High prices in high-income countries were often justified by the need to support innovation, while lower prices in low-income countries aimed to improve access[3].

Pharmaceutical Arbitrage

The significant price differences between countries created opportunities for pharmaceutical arbitrage, where drugs were imported from countries with lower prices to those with higher prices. This practice, while beneficial for consumers, posed challenges for pharmaceutical companies aiming to maintain profitability[3].

Financial Trajectory

Revenue and Profitability

FORTOVASE generated substantial revenue for its manufacturer, particularly during its peak usage period. However, the financial trajectory was also influenced by the high costs associated with research and development, marketing, and the need to maintain profitability in a competitive market[3].

Cost of Development and Marketing

The development of antiretroviral drugs, including FORTOVASE, is a costly endeavor. The expenses include not only the research and development phase but also significant marketing and regulatory compliance costs. These costs are often reflected in the final pricing of the drug[3].

Regulatory and Market Changes

Withdrawal from the Market

FORTOVASE was eventually withdrawn from the market, a decision likely influenced by several factors including the emergence of more effective and convenient antiretroviral therapies, changes in regulatory environments, and shifts in market demand. The formulation was replaced by other saquinavir products and combination therapies that offered better efficacy and tolerability profiles[4].

Impact on Public Health

Access to Antiretroviral Therapy

Despite its withdrawal, FORTOVASE played a crucial role in expanding access to antiretroviral therapy, especially during a period when treatment options were limited. The drug's availability, particularly in combination with other antiretrovirals like ritonavir, helped in managing HIV infection and improving patient outcomes[1][4][5].

Key Takeaways

• Improved Bioavailability: FORTOVASE offered significantly higher bioavailability compared to INVIRASE, enhancing its therapeutic efficacy.
• Market Competition: The drug faced intense competition in the antiretroviral market, impacting its market share and financial performance.
• Pricing Strategies: Pricing was influenced by R&D costs, regulatory environments, and the need to balance innovation with access.
• Regulatory Changes: The eventual withdrawal of FORTOVASE was likely due to the emergence of better treatment options and changes in market demand.
• Public Health Impact: FORTOVASE contributed to the expansion of antiretroviral therapy access, improving patient outcomes during its time on the market.

FAQs

What was the primary advantage of FORTOVASE over INVIRASE?

FORTOVASE had a significantly higher bioavailability compared to INVIRASE, leading to greater therapeutic efficacy.

How did coadministered drugs affect FORTOVASE's pharmacokinetics?

Coadministered drugs like ritonavir, clarithromycin, and ketoconazole significantly altered the pharmacokinetics of FORTOVASE, often increasing its plasma concentrations.

Why was FORTOVASE withdrawn from the market?

FORTOVASE was withdrawn likely due to the emergence of more effective and convenient antiretroviral therapies, along with changes in regulatory environments and market demand.

How did pharmaceutical arbitrage impact the pricing of FORTOVASE?

Pharmaceutical arbitrage, where drugs were imported from lower-priced markets to higher-priced ones, affected the profitability of FORTOVASE and other antiretroviral drugs.

What was the impact of FORTOVASE on public health?

FORTOVASE expanded access to antiretroviral therapy, particularly when used in combination with other drugs, and improved patient outcomes during its time on the market.

Sources

1. FORTOVASE® soft gelatin capsules - Medicines.org.au
2. Influence of Temperature and Concentration on the Self-Assembly of ... - ACS Publications
3. Pharmaceutical Arbitrage: Balancing Access and Innovation in ... - BU Law Scholarship
4. INVIRASE - FDA
5. FORTOVASE (saquinavir) SOFT GELATIN CAPSULES - FDA