FUSILEV Drug Patent Profile

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

Fusilev is a drug marketed by Acrotech Biopharma and is included in one NDA.

The generic ingredient in FUSILEV is levoleucovorin calcium. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fusilev

A generic version of FUSILEV was approved as levoleucovorin calcium by SANDOZ on March 9^th, 2015.

Summary for FUSILEV

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	5
Patent Applications:	5,851
Drug Prices:	Drug price information for FUSILEV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FUSILEV
What excipients (inactive ingredients) are in FUSILEV?	FUSILEV excipients list
DailyMed Link:	FUSILEV at DailyMed

See drug prices for FUSILEV

Recent Clinical Trials for FUSILEV

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

Sponsor	Phase
Academic and Community Cancer Research United	Phase 1/Phase 2
National Cancer Institute (NCI)	Phase 1/Phase 2
University of Southern California	Phase 3

See all FUSILEV clinical trials

Paragraph IV (Patent) Challenges for FUSILEV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FUSILEV	Injection	levoleucovorin calcium	50 mg/vial	020140	1	2013-12-19
FUSILEV	Injection	levoleucovorin calcium	10 mg/mL, 17.5 mL vial and 25 mL vial	020140	1	2011-10-26

US Patents and Regulatory Information for FUSILEV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	POWDER;INTRAVENOUS	020140-001	Mar 7, 2008		DISCN	Yes	No
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-002	Apr 29, 2011		DISCN	Yes	No
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-003	Apr 29, 2011		DISCN	Yes	No

Expired US Patents for FUSILEV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	POWDER;INTRAVENOUS	020140-001	Mar 7, 2008	6,500,829
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-003	Apr 29, 2011	6,500,829
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-002	Apr 29, 2011	6,500,829

International Patents for FUSILEV

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

Country	Patent Number	Title	Estimated Expiration
Australia	598024
Spain	2191669
European Patent Office	0266042	Dérivés de ptéridine optiquement actifs (Optically active pteridine derivatives)
Japan	H11106342	COMPOSITION OBTAINED BY USING OPTICALLY ACTIVE COMPOUND

FUSILEV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of FUSILEV

Introduction to FUSILEV

FUSILEV, also known as levoleucovorin, is a folate analog developed by Spectrum Pharmaceuticals. It is indicated for several critical medical uses, including rescue after high-dose methotrexate therapy, diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination, and the treatment of adults with metastatic colorectal cancer in combination with fluorouracil[4].

Historical Sales Performance

Historically, FUSILEV has been a significant revenue generator for Spectrum Pharmaceuticals. In the second quarter of 2013, FUSILEV net sales were $12.9 million, contributing substantially to the company's product revenues[3].

By 2016, FUSILEV continued to be a major product for Spectrum, although the company noted that sales declines in the FUSILEV market were expected to continue, albeit at a slowing rate. This decline was part of a broader trend where the company was shifting its focus towards newer growth franchises[2].

Market Position and Competition

FUSILEV holds a unique position in the market due to its specific indications and usage. It is the only levoleucovorin product approved by the FDA that contains sodium in its formulation, which was highlighted during the approval of Khapzory, another levoleucovorin product by Spectrum[1].

Despite being a niche product, FUSILEV faces competition from other folate analogs and rescue therapies. However, its specific formulation and FDA approvals have maintained its market relevance.

Financial Impact on Spectrum Pharmaceuticals

The financial performance of FUSILEV has significantly impacted Spectrum Pharmaceuticals. In 2013, the product contributed to the company's consolidated revenues, which totaled $33.2 million, with FUSILEV net sales being a substantial portion of this figure[3].

In 2016, total product sales for Spectrum, which included FUSILEV, were $128.6 million. Although FUSILEV sales were declining, the product still generated considerable revenue. The company's financial health was also influenced by its cash reserves, which stood at $158.2 million at the end of 2016, and its debt of $97.0 million[2].

Strategic Shifts and Divestiture

In a significant strategic move, Spectrum Pharmaceuticals divested its marketed portfolio, including FUSILEV, to Acrotech Biopharma in a deal worth up to $300 million. This divestiture marked a major shift for Spectrum, allowing the company to focus on novel oncology drug development and commercialization. The proceeds from the sale were intended to strengthen Spectrum's financial position and fund the development of its late-stage pipeline assets, such as Rolontis and poziotinib[1].

Regulatory and Market Approval

FUSILEV has undergone rigorous clinical trials and has received FDA approvals for its various indications. The drug's safety and efficacy have been established through these trials, which have been crucial for its market approval and continued use[4].

Clinical Usage and Dosage

FUSILEV is administered in specific dosages depending on its indication. For rescue after high-dose methotrexate therapy, it is administered intravenously every 6 hours until the serum methotrexate level is below a certain threshold. In the treatment of metastatic colorectal cancer, it is used in combination with fluorouracil, following specific dosing regimens[4].

Safety Considerations

The drug comes with several safety considerations, including contraindications for patients with previous allergic reactions to levoleucovorin or its components. It is also not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to a lack of vitamin B12 due to the risk of neurologic manifestations[4].

Global Market Presence

FUSILEV, under various trade names, is marketed outside the United States by major pharmaceutical companies such as Pfizer, Sanofi-Aventis, and Takeda. This global presence underscores its importance and demand in the oncology treatment market[3].

Financial Projections and Valuation

The financial trajectory of FUSILEV, and by extension Spectrum Pharmaceuticals, has been subject to various valuations and projections. In 2017, Spectrum's valuation was noted to be lower than its peers, with an EV/S multiple of 3.6x compared to the industry average of 16.2x. This suggested that the market may not have fully factored in the potential of Spectrum's pipeline, including the contributions from FUSILEV[2].

Conclusion

FUSILEV has been a critical component of Spectrum Pharmaceuticals' product portfolio, contributing significantly to the company's revenues and financial health. Despite declining sales, the drug's unique indications and FDA approvals have maintained its market relevance. The divestiture of FUSILEV as part of Spectrum's strategic shift towards novel oncology drugs marks a new chapter in the company's focus on innovative therapies.

Key Takeaways

• Historical Sales: FUSILEV has been a major revenue generator for Spectrum Pharmaceuticals.
• Market Position: It holds a unique position due to its specific indications and FDA approvals.
• Financial Impact: The drug has significantly impacted Spectrum's financial health and strategic decisions.
• Regulatory Approvals: FUSILEV has undergone rigorous clinical trials and received FDA approvals.
• Clinical Usage: It is administered in specific dosages for different indications.
• Safety Considerations: The drug comes with several safety considerations and contraindications.
• Global Presence: FUSILEV is marketed globally by major pharmaceutical companies.

Frequently Asked Questions

What are the primary indications for FUSILEV?

FUSILEV is indicated for rescue after high-dose methotrexate therapy, diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination, and the treatment of adults with metastatic colorectal cancer in combination with fluorouracil[4].

How has FUSILEV contributed to Spectrum Pharmaceuticals' financial health?

FUSILEV has been a significant revenue generator for Spectrum Pharmaceuticals, contributing to the company's product sales and influencing its financial health and strategic decisions[2][3].

What was the outcome of the divestiture of FUSILEV by Spectrum Pharmaceuticals?

The divestiture of FUSILEV to Acrotech Biopharma was part of a strategic shift by Spectrum to focus on novel oncology drug development and commercialization. The deal provided Spectrum with up to $300 million, strengthening its financial position and funding its late-stage pipeline assets[1].

How is FUSILEV administered?

FUSILEV is administered intravenously in specific dosages depending on its indication. For high-dose methotrexate therapy rescue, it is given every 6 hours until the serum methotrexate level is below a certain threshold. In metastatic colorectal cancer treatment, it is used in combination with fluorouracil following specific regimens[4].

What safety considerations are associated with FUSILEV?

FUSILEV is contraindicated for patients with previous allergic reactions to levoleucovorin or its components. It is also not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to a lack of vitamin B12 due to the risk of neurologic manifestations[4].

Sources

1. Biospace: "Spectrum Pharma Sells Marketed Portfolio of 7 Drugs to Acrotech for $300 Million Deal"[1]
2. Stonegate Capital Partners: "Company Description - Spectrum Pharmaceuticals"[2]
3. Business Wire: "Spectrum Pharmaceuticals Reports Financial Results for Second Quarter 2013"[3]
4. Drugs.com: "Fusilev: Package Insert / Prescribing Information"[4]