NELFINAVIR MESYLATE - Generic Drug Details

What are the generic drug sources for nelfinavir mesylate and what is the scope of freedom to operate?

Nelfinavir mesylate is the generic ingredient in one branded drug marketed by Agouron Pharms and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for NELFINAVIR MESYLATE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	86
Patent Applications:	5,949
What excipients (inactive ingredients) are in NELFINAVIR MESYLATE?	NELFINAVIR MESYLATE excipients list
DailyMed Link:	NELFINAVIR MESYLATE at DailyMed

Recent Clinical Trials for NELFINAVIR MESYLATE

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

Sponsor	Phase
Mayo Clinic	Phase 1
University of Washington	Phase 2
AIDS Malignancy Consortium	Phase 2

See all NELFINAVIR MESYLATE clinical trials

Pharmacology for NELFINAVIR MESYLATE

Drug Class	Protease Inhibitor
Mechanism of Action	Cytochrome P450 3A Inhibitors HIV Protease Inhibitors

Medical Subject Heading (MeSH) Categories for NELFINAVIR MESYLATE

HIV Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NELFINAVIR MESYLATE

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

US Patents and Regulatory Information for NELFINAVIR MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Agouron Pharms	VIRACEPT	nelfinavir mesylate	POWDER;ORAL	020778-001	Mar 14, 1997		DISCN	No	No
Agouron Pharms	VIRACEPT	nelfinavir mesylate	TABLET;ORAL	021503-001	Apr 30, 2003		RX	Yes	Yes
Agouron Pharms	VIRACEPT	nelfinavir mesylate	TABLET;ORAL	020779-001	Mar 14, 1997		RX	Yes	Yes

Expired US Patents for NELFINAVIR MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Agouron Pharms	VIRACEPT	nelfinavir mesylate	TABLET;ORAL	020779-001	Mar 14, 1997
Agouron Pharms	VIRACEPT	nelfinavir mesylate	TABLET;ORAL	021503-001	Apr 30, 2003
Agouron Pharms	VIRACEPT	nelfinavir mesylate	POWDER;ORAL	020778-001	Mar 14, 1997
Agouron Pharms	VIRACEPT	nelfinavir mesylate	TABLET;ORAL	021503-001	Apr 30, 2003
Agouron Pharms	VIRACEPT	nelfinavir mesylate	TABLET;ORAL	020779-001	Mar 14, 1997
Agouron Pharms	VIRACEPT	nelfinavir mesylate	TABLET;ORAL	020779-001	Mar 14, 1997
Agouron Pharms	VIRACEPT	nelfinavir mesylate	POWDER;ORAL	020778-001	Mar 14, 1997

NELFINAVIR MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nelfinavir Mesylate

Introduction

Nelfinavir mesylate, known by its brand name Viracept, is a potent HIV-1 protease inhibitor that has been in use since its FDA approval in March 1997. Initially developed by Agouron Pharmaceuticals, it has undergone significant research and development, expanding its potential uses beyond HIV treatment. Here, we delve into the market dynamics and financial trajectory of nelfinavir mesylate.

Historical Market Performance

When nelfinavir mesylate was first launched, it marked one of the largest biotech launches in pharmaceutical history, achieving first full-year sales of over $335 million[4]. This initial success was a significant milestone, reflecting the high demand for effective antiretroviral therapies at the time.

Patent Expiration and Generic Competition

The patent on nelfinavir mesylate expired in 2014, which led to the entry of generic competitors into the market. This shift has impacted the financial trajectory of the drug, as generic versions typically reduce the market share and revenue of the original branded product.

Expanded Therapeutic Uses

Beyond its primary use as an HIV protease inhibitor, nelfinavir mesylate has been investigated for its potential in treating various types of cancer, including prostate and brain tumors. It induces endoplasmic reticulum stress, autophagy, and apoptosis in cancer cells, making it a promising agent in oncology research[1][3][4].

Anti-Cancer Research and Clinical Trials

Several clinical trials are ongoing or have been completed to evaluate the efficacy of nelfinavir mesylate as a cancer therapeutic agent. These trials often involve nelfinavir as a monotherapy or in combination with other cancer treatments. The ongoing research and potential approvals in new therapeutic areas could revitalize the market dynamics and financial performance of the drug.

Radiosensitization

As of April 2022, nelfinavir mesylate is being studied as a radiosensitizing agent in the treatment of advanced cervical cancer. This new application could open up additional market opportunities and influence the financial trajectory positively[4].

Market Impact of COVID-19

Nelfinavir mesylate has also been evaluated for its antiviral activity against COVID-19. It has been shown to inhibit cell fusion caused by the SARS-CoV-2 spike glycoprotein, suggesting potential use in COVID-19 treatment. This could have temporarily boosted demand and revenue during the pandemic[3].

Financial Trajectory

Revenue Trends

The revenue from nelfinavir mesylate has declined significantly since the expiration of its patent in 2014. The entry of generic competitors has reduced the market share and pricing power of the original branded product. However, ongoing research and potential new therapeutic uses could stabilize or even increase revenue in the future.

Research and Development Expenses

Companies involved in the research and development of nelfinavir mesylate for new indications incur substantial expenses. For example, the financial reports of pharmaceutical companies like Impel Pharmaceuticals, although not directly related to nelfinavir, illustrate the high costs associated with clinical trials and product development. These expenses can impact the overall financial health of companies involved in such research[2].

Competitive Landscape

The competitive landscape for HIV protease inhibitors has evolved significantly since the introduction of nelfinavir mesylate. Other drugs have been developed and approved, offering alternative treatment options for HIV patients. In the cancer treatment segment, nelfinavir mesylate faces competition from established and emerging therapies, making market penetration challenging.

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market dynamics of any pharmaceutical product. Nelfinavir mesylate's approval for new indications, such as cancer treatment, would require rigorous clinical trials and regulatory clearance. The regulatory environment can either facilitate or hinder the financial trajectory of the drug.

Future Outlook

Potential for New Indications

The ongoing research into nelfinavir mesylate's anti-cancer properties and its potential use in radiosensitization and COVID-19 treatment presents opportunities for market growth. Successful clinical trials and regulatory approvals could lead to increased revenue and a more stable financial trajectory.

Generic Competition

Despite the potential for new indications, the presence of generic competitors will continue to impact the pricing and market share of nelfinavir mesylate. This competition will likely keep the revenue from the original branded product in check.

Key Takeaways

• Historical Success: Nelfinavir mesylate had a strong market launch and initial sales performance.
• Patent Expiration: The expiration of its patent led to generic competition, reducing revenue.
• Expanded Therapeutic Uses: Ongoing research into anti-cancer and other therapeutic uses could revitalize market dynamics.
• Regulatory Environment: Regulatory approvals are crucial for new indications and market growth.
• Competitive Landscape: The drug faces competition from other HIV protease inhibitors and cancer therapies.

FAQs

What is nelfinavir mesylate primarily used for?

Nelfinavir mesylate is primarily used as an HIV-1 protease inhibitor to treat HIV/AIDS.

What are the potential new therapeutic uses of nelfinavir mesylate?

Nelfinavir mesylate is being researched for its potential in treating various types of cancer, as a radiosensitizing agent, and for its antiviral activity against COVID-19.

How has the patent expiration affected the market dynamics of nelfinavir mesylate?

The patent expiration in 2014 led to the entry of generic competitors, reducing the market share and revenue of the original branded product.

What are the current financial trends for nelfinavir mesylate?

The revenue from nelfinavir mesylate has declined due to generic competition, but ongoing research into new indications could stabilize or increase revenue in the future.

What regulatory approvals are necessary for nelfinavir mesylate to be used in new indications?

Nelfinavir mesylate would require regulatory approvals for new indications such as cancer treatment, which involves rigorous clinical trials and clearance from regulatory bodies.

Sources:

1. Cell Signaling Technology - Nelfinavir Mesylate.
2. Biospace - Impel Pharmaceuticals Announces Second Quarter 2022 Financial Results.
3. R&D Systems - Nelfinavir mesylate.
4. Wikipedia - Nelfinavir.