FUZEON Drug Patent Profile

Which patents cover Fuzeon, and what generic alternatives are available?

Fuzeon is a drug marketed by Roche and is included in one NDA.

The generic ingredient in FUZEON is enfuvirtide. One supplier is listed for this compound. Additional details are available on the enfuvirtide profile page.

Summary for FUZEON

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	24
Patent Applications:	5,060
Drug Prices:	Drug price information for FUZEON
What excipients (inactive ingredients) are in FUZEON?	FUZEON excipients list
DailyMed Link:	FUZEON at DailyMed

See drug prices for FUZEON

Recent Clinical Trials for FUZEON

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Early Phase 1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Early Phase 1
Sidney Kimmel Comprehensive Cancer Center	Early Phase 1

See all FUZEON clinical trials

US Patents and Regulatory Information for FUZEON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	FUZEON	enfuvirtide	INJECTABLE;SUBCUTANEOUS	021481-001	Mar 13, 2003		RX	Yes	Yes

Expired US Patents for FUZEON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	FUZEON	enfuvirtide	INJECTABLE;SUBCUTANEOUS	021481-001	Mar 13, 2003	5,464,933
Roche	FUZEON	enfuvirtide	INJECTABLE;SUBCUTANEOUS	021481-001	Mar 13, 2003	6,133,418
Roche	FUZEON	enfuvirtide	INJECTABLE;SUBCUTANEOUS	021481-001	Mar 13, 2003	6,475,491

EU/EMA Drug Approvals for FUZEON

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Fuzeon	enfuvirtide	EMEA/H/C/000514 Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse-transcriptase inhibitors and nucleoside reverse-transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate.	Authorised	no	no	no	2003-05-27

International Patents for FUZEON

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	311319	The treatment of HIV and other viral infections using the peptide DP-178 or DP-107 in combination therapy
European Patent Office	1595890
Japan	H11507632
Denmark	0774971
Australia	692777
Canada	2224008	THERAPIE COMBINATOIRE POUR LE TRAITEMENT D'INFECTIONS VIRALES VIH ET AUTRES (THE TREATMENT OF HIV AND OTHER VIRAL INFECTIONS USING COMBINATORIAL THERAPY)

Supplementary Protection Certificates for FUZEON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0774971	CA 2005 00042	Denmark
0774971	C300192	Netherlands		PRODUCT NAME: ENFUVIRTIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER; NAT. REGISTRATION NO/DATE: EU/1/03/252/001EU/1/03/252/002EU/1/03/252/003 2003270527; FIRST REGISTRATION: CH/56282 20030430
0774971	SPC/GB05/026	United Kingdom		PRODUCT NAME: ENFUVIRTIDE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER; REGISTERED: CH CH 56,282 20030430; UK EU/1/03/252/001 20030527; UK EU/1/03/252/002 20030527; UK EU/1/03/252/003 20030527
0774971	C00774971/01	Switzerland		FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
0774971	05C0018	France		PRODUCT NAME: ENFUVIRTIDE; NAT. REGISTRATION NO/DATE: EU/1/03/252/001-003 20030527; FIRST REGISTRATION: LI - CH 56282 01 20030430
0774971	300192	Netherlands		300192, 20140607, EXPIRES: 20180429

FUZEON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Fuzeon (Enfuvirtide)

Introduction

Fuzeon, also known as enfuvirtide, was a groundbreaking HIV fusion inhibitor approved by the FDA in 2003 for the treatment of advanced HIV-1 infection. Despite its clinical significance, the drug's market dynamics and financial trajectory have been marked by several challenges and controversies.

Approval and Initial Market Reception

Fuzeon was the first FDA-approved HIV fusion inhibitor, marking a significant milestone in HIV treatment. However, its approval was quickly overshadowed by concerns over its high price. The drug was priced at around £12,800 annually in Europe, which was more than triple the cost of any other antiretroviral drug at the time[1].

Production Complexity and Cost

The manufacture of Fuzeon was highly complex, requiring three times the normal number of ingredients and four times the average number of processing steps. This complexity contributed to its high production costs, which Roche, the drug's distributor, cited as a justification for the drug's price[1].

Clinical Efficacy

Despite the cost concerns, Fuzeon demonstrated significant clinical efficacy. Studies such as TORO 1 and 2 showed that the addition of Fuzeon to a combination of other antiretroviral medications resulted in more durable and larger reductions in HIV viral load compared to the background antiretrovirals alone. However, the drug was associated with injection site reactions in nearly all patients, which added to its overall impact on quality of life[1][5].

Market Impact and Access Issues

The high price of Fuzeon led to significant access issues. In the U.S., the AIDS Drug Assistance Programs (ADAPs), which provide medication to people with HIV who are uninsured or underinsured, faced substantial challenges in incorporating Fuzeon into their formularies. The cost was so prohibitive that it forced ADAP programs to limit enrollment or cut other lifesaving drugs, exacerbating existing waiting lists and healthcare disparities[1].

Financial Controversies

Activists and healthcare providers criticized Roche for the drug's pricing, arguing that it was excessive and not justified by the production costs. There were also questions about the actual research and development costs, with some suggesting that Roche had spent significantly less than the claimed $600 million, and that a portion of these costs were covered by the National Institutes of Health (NIH)[1].

Market Evolution and Alternative Treatments

Over time, the HIV treatment landscape evolved with the introduction of newer, more effective, and often less expensive antiretroviral therapies. These alternatives reduced the medical need for Fuzeon, leading to a decline in its market presence. By 2024, Genentech, which had taken over the distribution of Fuzeon, announced that it would discontinue all marketing and commercial distribution of the drug in the United States by February 28, 2025, citing evolving clinical practices and reduced medical need[3].

Discontinuation and Patient Support

The decision to discontinue Fuzeon was not related to any quality, safety, or efficacy issues but rather to the availability of better treatment options. Genentech committed to supporting patients and healthcare providers during the transition, encouraging patients to discuss alternative treatment options with their doctors[3].

Financial Trajectory

The financial trajectory of Fuzeon was marked by high initial costs and subsequent decline in revenue. The drug's complex production process and high pricing strategy limited its accessibility and adoption. As newer treatments emerged, the demand for Fuzeon decreased, leading to a significant reduction in its market share and eventual discontinuation.

Production Constraints

Initially, only 12,000 to 15,000 patients worldwide had access to Fuzeon due to production constraints, further limiting its financial potential[1].

Revenue Impact

The high price and limited accessibility meant that while Fuzeon generated significant revenue initially, its long-term financial performance was hampered by the inability to expand its market reach.

Conclusion

Fuzeon's market dynamics and financial trajectory were characterized by a promising start marred by high production costs, access issues, and eventually, the emergence of more effective and affordable alternatives. Despite its clinical efficacy, the drug's financial viability was compromised by its pricing strategy and the evolving landscape of HIV treatments.

Key Takeaways

• High Production Costs: Fuzeon's complex manufacturing process contributed to its high price.
• Access Issues: The drug's cost led to significant access problems, particularly for uninsured or underinsured patients.
• Clinical Efficacy: Fuzeon showed significant reductions in HIV viral load but was associated with injection site reactions.
• Market Evolution: The introduction of newer antiretroviral therapies reduced the medical need for Fuzeon.
• Discontinuation: Genentech discontinued Fuzeon in the U.S. due to reduced medical need and evolving clinical practices.

FAQs

Q: What was the primary reason for the high price of Fuzeon?

A: The high price of Fuzeon was largely due to its complex manufacturing process, which required three times the normal number of ingredients and four times the average number of processing steps[1].

Q: How did the introduction of Fuzeon affect ADAP programs?

A: The introduction of Fuzeon put significant pressure on ADAP programs, forcing them to limit enrollment or cut other lifesaving drugs due to the drug's high cost[1].

Q: Why did Genentech decide to discontinue Fuzeon?

A: Genentech decided to discontinue Fuzeon due to evolving clinical practices and significantly reduced medical need resulting from the availability of novel alternative treatment options[3].

Q: What were the clinical benefits of Fuzeon?

A: Fuzeon demonstrated significant reductions in HIV viral load and increases in CD4 counts when added to a combination of other antiretroviral medications[1][5].

Q: How did the market reception of Fuzeon impact its financial performance?

A: The high price and limited accessibility of Fuzeon limited its market reach and long-term financial performance, despite initial revenue generation[1][3].

Sources

1. Fuzeon fury: price of first FDA-approved HIV fusion inhibitor sparks protest in US - AIDSmap
2. HIV-1 Fusion Inhibitor Peptides Enfuvirtide and T-1249 Interact with Erythrocyte and Lymphocyte Membranes - PLoS ONE
3. Genentech Provides Update on Fuzeon® (enfuvirtide) in the United States - Genentech
4. HIV Medication Assistance Programs - AIDS Education and Training Centers
5. Fuzeon - European Medicines Agency (EMA)