EVOMELA Drug Patent Profile

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

Evomela is a drug marketed by Acrotech Biopharma and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and one patent family members in twenty-two countries.

The generic ingredient in EVOMELA is melphalan hydrochloride. There are twelve drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Evomela

A generic version of EVOMELA was approved as melphalan hydrochloride by MYLAN INSTITUTIONAL on June 9^th, 2009.

Summary for EVOMELA

International Patents:	101
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	20
Patent Applications:	923
Drug Prices:	Drug price information for EVOMELA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVOMELA
What excipients (inactive ingredients) are in EVOMELA?	EVOMELA excipients list
DailyMed Link:	EVOMELA at DailyMed

See drug prices for EVOMELA

Recent Clinical Trials for EVOMELA

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

Sponsor	Phase
Ehsan Malek	Early Phase 1
Washington University School of Medicine	Phase 1
National Cancer Institute (NCI)	Phase 1/Phase 2

See all EVOMELA clinical trials

Pharmacology for EVOMELA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Paragraph IV (Patent) Challenges for EVOMELA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EVOMELA	Injection	melphalan hydrochloride	50 mg/vial	207155	1	2017-09-08

US Patents and Regulatory Information for EVOMELA

EVOMELA is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes	10,940,128		Y
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes	8,410,077		Y
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes	10,040,872		Y

International Patents for EVOMELA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2012528795
China	104704007	Alkylated cyclodextrin compositions and processes for preparing and using the same
Japan	2012072160	SULFOALKYL ETHER CYCLODEXTRIN COMPOSITION

Supplementary Protection Certificates for EVOMELA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	CR 2022 00054	Denmark		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	CA 2022 00054	Denmark		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	23C1000	France		PRODUCT NAME: MELPHALAN FLUFENAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/22/1669 20220818

EVOMELA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EVOMELA

Introduction to EVOMELA

EVOMELA, a formulation of melphalan hydrochloride for injection, is a crucial drug in the treatment of multiple myeloma, particularly for patients undergoing autologous stem cell transplantation (ASCT). Developed by Ligand Pharmaceuticals and licensed to Spectrum Pharmaceuticals, EVOMELA has marked a significant milestone in cancer therapy.

FDA Approval and Regulatory Pathway

EVOMELA received FDA approval in March 2016 based on its bioequivalence to the standard melphalan formulation (Alkeran) in a Phase 2 clinical study. This approval was granted via the 505(b)(2) regulatory pathway, which allows for a faster and more streamlined process for drugs that are similar to existing approved drugs[1][4].

Market Indications and Patient Population

EVOMELA is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. Multiple myeloma is the second most common hematologic disease, with nearly 30,000 new cases projected in the U.S. annually. The drug's approval has filled a critical need in this patient population, especially given its unique formulation and stability advantages[1][5].

Formulation and Stability

One of the key differentiators of EVOMELA is its stability profile. Unlike other melphalan formulations that require a propylene glycol-containing cosolvent, EVOMELA uses Captisol technology, which improves solubility and stability. This formulation is free from propylene glycol, reducing the risk of renal and cardiac side effects associated with traditional formulations. EVOMELA offers a 4-hour admixture stability, allowing for greater scheduling flexibility and potentially simpler clinical use and administration logistics[2][4].

Clinical Efficacy and Safety

The pivotal Phase 2 clinical study demonstrated the efficacy and acceptable safety profile of EVOMELA as a high-dose conditioning regimen for ASCT in patients with multiple myeloma. The study showed an overall response rate improvement from 79% before ASCT to 95% at 90 to 100 days post-transplant. Additionally, there was an increase in the number of patients achieving a stringent complete response. The safety profile was consistent with myeloablative chemotherapy, with no new safety signals identified[4][5].

Financial Implications for Ligand Pharmaceuticals

The approval of EVOMELA has significant financial implications for Ligand Pharmaceuticals. Ligand received an upfront fee and a $6 million milestone payment upon EVOMELA’s FDA approval. Additionally, Ligand is entitled to royalties on the net sales of EVOMELA. This partnership exemplifies Ligand’s strategy of sharing in the economic success of innovative drugs through strategic partnerships[1].

Market Size and Growth Potential

The current IV melphalan market is approximately $100 million annually, with predominant use in ASCT. Given that EVOMELA is the only IV melphalan product approved for high-dose conditioning in this setting, it is well-positioned to capture a significant share of this market. The growing rate of ASCT for multiple myeloma patients, increasing by approximately 3.3% annually, further supports the growth potential of EVOMELA[1].

Revenue Projections and Milestones

Ligand Pharmaceuticals expects to benefit from the royalties generated by EVOMELA sales. While the exact revenue projections for EVOMELA are not detailed, Ligand’s overall royalty income has been increasing, driven by the success of its partnered products. For instance, in the second quarter of 2024, Ligand reported royalties of $42.3 million, up from $38.6 million in the same period in 2023[3].

Competitive Landscape

EVOMELA’s unique formulation and FDA approval for high-dose conditioning in multiple myeloma patients undergoing ASCT position it favorably in the market. The elimination of propylene glycol and the improved stability profile are significant advantages over traditional melphalan formulations. This differentiation is expected to drive market share and adoption among healthcare providers[2][4].

Challenges and Risks

Despite the positive market dynamics, there are challenges and risks associated with EVOMELA. These include the potential for smaller-than-anticipated patient populations, delays in commercial launch, and the inherent risks associated with myeloablative chemotherapy. Additionally, the competitive landscape in cancer therapies is highly dynamic, and new treatments could potentially impact EVOMELA’s market share[1].

Expert Insights

"Through partnerships such as this one, Ligand is able to share in the economic success of important, innovative new drugs across a range of indications and patient populations," said John Higgins, Chief Executive Officer of Ligand Pharmaceuticals. This statement underscores the strategic importance of EVOMELA in Ligand’s portfolio and its potential to contribute significantly to the company’s financial performance[1].

Key Statistics

• FDA Approval: March 2016
• Market Size: Approximately $100 million annually for IV melphalan products
• Growth Rate: ASCT for multiple myeloma patients increasing by 3.3% annually
• Milestone Payment: $6 million to Ligand upon FDA approval
• Royalties: Ligand entitled to royalties on net sales of EVOMELA[1][3].

Conclusion

EVOMELA has carved out a niche in the treatment of multiple myeloma, particularly for patients undergoing ASCT. Its unique formulation, stability advantages, and FDA approval position it for significant market impact. The financial trajectory for EVOMELA is promising, with potential for substantial revenue generation through royalties and milestone payments.

Key Takeaways

• Unique Formulation: EVOMELA uses Captisol technology, eliminating the need for propylene glycol and improving stability.
• FDA Approval: Approved in March 2016 for high-dose conditioning in multiple myeloma patients undergoing ASCT.
• Market Potential: Significant market share in the $100 million IV melphalan market.
• Financial Benefits: Ligand Pharmaceuticals to receive royalties and milestone payments.
• Clinical Efficacy: Demonstrated efficacy and acceptable safety profile in clinical studies.

FAQs

What is EVOMELA used for?

EVOMELA is used as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.

What makes EVOMELA different from other melphalan formulations?

EVOMELA is free from propylene glycol and uses Captisol technology, which improves its solubility and stability, allowing for longer use and infusion times.

Who developed and licensed EVOMELA?

EVOMELA was developed by Ligand Pharmaceuticals and licensed to Spectrum Pharmaceuticals.

What was the financial impact of EVOMELA’s FDA approval on Ligand Pharmaceuticals?

Ligand received a $6 million milestone payment upon EVOMELA’s FDA approval and is entitled to royalties on the net sales of EVOMELA.

What are the potential risks associated with EVOMELA?

Potential risks include smaller-than-anticipated patient populations, delays in commercial launch, and the inherent risks associated with myeloablative chemotherapy.

Cited Sources

1. Ligand Partner Spectrum Pharma Receives FDA Approval Of EVOMELA - Biospace
2. EVOMELA Stability - EVOMELA.com
3. Ligand Reports Second Quarter 2024 Financial Results - Ligand Pharmaceuticals Investor Relations
4. Spectrum Pharmaceuticals, Inc. Announces Publication Of Pivotal EVOMELA Data - Biospace
5. EVOMELA (melphalan) for injection - FDA Label[1][2][4][5]