INVIRASE Drug Patent Profile

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

Invirase is a drug marketed by Hoffmann La Roche and Hoffmann-la Roche and is included in two NDAs.

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

Summary for INVIRASE

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	12
Patent Applications:	4,300
Drug Prices:	Drug price information for INVIRASE
What excipients (inactive ingredients) are in INVIRASE?	INVIRASE excipients list
DailyMed Link:	INVIRASE at DailyMed

See drug prices for INVIRASE

Recent Clinical Trials for INVIRASE

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

Sponsor	Phase
Hoffmann-La Roche	Phase 1
Hoffmann-La Roche	Phase 2
National Institutes of Health (NIH)	Phase 2/Phase 3

See all INVIRASE clinical trials

US Patents and Regulatory Information for INVIRASE

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	INVIRASE	saquinavir mesylate	CAPSULE;ORAL	020628-001	Dec 6, 1995		DISCN	Yes	No
Hoffmann-la Roche	INVIRASE	saquinavir mesylate	TABLET;ORAL	021785-001	Dec 17, 2004		DISCN	Yes	No

Expired US Patents for INVIRASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	INVIRASE	saquinavir mesylate	CAPSULE;ORAL	020628-001	Dec 6, 1995
Hoffmann-la Roche	INVIRASE	saquinavir mesylate	TABLET;ORAL	021785-001	Dec 17, 2004

International Patents for INVIRASE

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

Country	Patent Number	Title	Estimated Expiration
Germany	19675051
Portugal	96145	PROCESSO PARA A PREPARACAO DE NOVOS DERIVADOS DE AMINOACIDOS E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM
Poland	165225
Czech Republic	9005765
Bulgaria	51452	PROCESS FOR THE MANUFACTURE OF AMINO ACID DERIVATIVES
European Patent Office	0432695	Dérivés d'acides aminés. (Amino acid derivatives.)
Czech Republic	280558	Deriváty aminokyselin, způsob jejich výroby, jejich použití a léčiva na jejich bázi (DERIVATIVES OF AMINO ACIDS, PROCESS OF THEIR PREPARATION, THEIR USE AND MEDICAMENTS BASED THEREON)

Supplementary Protection Certificates for INVIRASE

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

INVIRASE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INVIRASE (Saquinavir Mesylate)

Introduction to INVIRASE

INVIRASE, also known as saquinavir mesylate, is a protease inhibitor used in the treatment of HIV-1 infection. It was one of the first protease inhibitors approved for use in the late 1990s.

Historical Context and Market Position

INVIRASE was introduced in the mid-1990s as a breakthrough in HIV treatment, marking a significant shift from earlier therapies. However, its market position has evolved over the years due to several factors.

Drug Class and Mechanism

INVIRASE belongs to the class of protease inhibitors, which work by inhibiting the protease enzyme of the HIV virus, thereby preventing the virus from replicating. This mechanism was revolutionary at the time of its introduction but has since been surpassed by newer, more effective treatments[4].

Market Challenges

Resistance and Cross-Resistance

One of the major challenges faced by INVIRASE is the development of drug resistance. Studies have shown that HIV isolates can develop resistance to saquinavir, particularly with mutations such as G48V and L90M. This resistance can also lead to cross-resistance with other protease inhibitors, reducing the drug's efficacy over time[4].

Side Effects and Patient Compliance

INVIRASE has been associated with various side effects, which can impact patient compliance. The drug requires a strict dosing regimen and is often taken in combination with other medications, which can be cumbersome for patients.

Newer Drugs and Generic Alternatives

The HIV drugs market has seen the introduction of newer, safer, and more effective treatments. Patients prefer these newer drugs due to their better safety profiles and lower risk of early drug resistance. This shift has significantly reduced the demand for older drugs like INVIRASE. Additionally, the emergence of generic alternatives has further eroded the market share of branded drugs like INVIRASE[1].

Financial Performance and Revenue Decline

The financial performance of INVIRASE has been on a decline due to the factors mentioned above. Here are some key points:

Revenue Forecasts

The global HIV drugs market is expected to grow, but this growth is driven by newer drugs and injectables. INVIRASE, being an older drug, does not contribute significantly to this growth. The market for protease inhibitors, in particular, has seen a decline as newer drug classes like integrase inhibitors and multi-class combination products gain prominence[3].

Company Financials

Companies that once relied heavily on INVIRASE have seen a decline in revenues from this drug. For instance, the financial reports of pharmaceutical companies involved in the HIV market show a shift towards newer products and therapies. Innoviva, which has a portfolio that includes royalties from HIV treatments, has seen growth driven by newer products rather than older ones like INVIRASE[5].

Market Restraining Factors

Demand for Newer Drugs

The preference for newer drugs with better safety profiles and lower resistance rates has been a significant restraining factor for INVIRASE. Patients and healthcare providers increasingly opt for drugs that offer improved outcomes and fewer side effects[1].

Social Stigma and Medical Mistrust

Social stigma and medical mistrust can also affect the market for HIV drugs, including INVIRASE. However, these factors are more general and affect the entire HIV treatment landscape rather than INVIRASE specifically[1].

Technological and Regulatory Environment

Regulatory Approvals and Updates

INVIRASE has undergone various regulatory updates and has been subject to drug interaction studies. However, the regulatory environment now favors newer drugs with more robust clinical data and better patient outcomes[4].

Technological Collaborations

The HIV drugs market has seen significant technological collaborations, particularly in the development of long-acting injectables and pre-exposure prophylaxis (PrEP) injectables. These advancements have further marginalized older drugs like INVIRASE[1].

Competitive Landscape

The competitive landscape of the HIV drugs market is dominated by newer and more effective treatments. Companies like Gilead Sciences, ViiV Healthcare, and AbbVie Inc. are leading the market with their innovative products. INVIRASE, once a key player, now holds a minor position in this competitive landscape[1][3].

Key Takeaways

• INVIRASE, a protease inhibitor, was a groundbreaking treatment in the 1990s but has seen a decline in use due to drug resistance and the emergence of newer treatments.
• The market for HIV drugs is driven by newer, safer, and more effective treatments, reducing the demand for older drugs like INVIRASE.
• Financial performance of companies associated with INVIRASE has been impacted by the shift towards newer therapies.
• Regulatory and technological advancements favor newer drugs, further marginalizing INVIRASE.

FAQs

What is INVIRASE used for?

INVIRASE (saquinavir mesylate) is used in the treatment of HIV-1 infection. It belongs to the class of protease inhibitors.

Why has the demand for INVIRASE declined?

The demand for INVIRASE has declined due to the development of drug resistance, the emergence of newer and more effective treatments, and the preference for drugs with better safety profiles.

What are the main challenges faced by INVIRASE in the market?

The main challenges include drug resistance, cross-resistance with other protease inhibitors, side effects, and the preference for newer drugs.

How has the financial performance of companies associated with INVIRASE been affected?

The financial performance has been impacted negatively due to the decline in demand and the shift towards newer therapies.

What are the current market trends in the HIV drugs sector?

Current trends include the growth of long-acting injectables, pre-exposure prophylaxis (PrEP) injectables, and the dominance of newer drug classes like integrase inhibitors and multi-class combination products.

Cited Sources:

1. GlobeNewswire - "HIV Drugs and Injectables Market Report 2024-2034: U.S. Targets to End the HIV Epidemic in the Country by 2030"[1]
2. Innoviva - "Innoviva Reports Second Quarter 2024 Financial Results; Highlights"[2]
3. Global Market Insights - "Anti-retroviral Drugs Market Size & Share – Trends Report, 2032"[3]
4. FDA - "INVIRASE (saquinavir mesylate) CAPSULES and TABLETS Product Information"[4]
5. Innoviva - "Innoviva Reports First Quarter 2024 Financial Results; Highlights Recent Company Progress"[5]