Elotuzumab - Biologic Drug Details

Summary for elotuzumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for elotuzumab

Recent Clinical Trials for elotuzumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Mayo Clinic	PHASE1
Bristol-Myers Squibb	PHASE1
Omar Nadeem, MD	PHASE1

See all elotuzumab clinical trials

Pharmacology for elotuzumab

Mechanism of Action	SLAMF7-directed Antibody Interactions
Established Pharmacologic Class	SLAMF7-directed Immunostimulatory Antibody
Chemical Structure	Antibodies, Monoclonal

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for elotuzumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for elotuzumab Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Bristol-myers Squibb Company	EMPLICITI	elotuzumab	For Injection	761035	7,709,610	2024-11-05	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for elotuzumab Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Bristol-myers Squibb Company	EMPLICITI	elotuzumab	For Injection	761035	10,017,492	2035-08-27	Patent claims search
Bristol-myers Squibb Company	EMPLICITI	elotuzumab	For Injection	761035	10,034,872	2035-08-20	Patent claims search
Bristol-myers Squibb Company	EMPLICITI	elotuzumab	For Injection	761035	10,047,163	2034-02-07	Patent claims search
Bristol-myers Squibb Company	EMPLICITI	elotuzumab	For Injection	761035	10,100,034	2037-07-25	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: Elotuzumab

Last updated: July 27, 2025

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Introduction

Elotuzumab (trade name: Empliciti) is a monoclonal antibody developed by AbbVie for the treatment of multiple myeloma (MM), a malignant plasma cell disorder. Approved by the U.S. Food and Drug Administration (FDA) in 2015, elotuzumab has positioned itself within a competitive landscape characterized by rapid innovation, evolving treatment paradigms, and shifting market dynamics. Analyzing its market trajectory necessitates understanding its clinical profile, competitive positioning, regulatory landscape, and commercial prospects.

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Clinical Profile and Therapeutic Focus

Elotuzumab targets SLAMF7 (Signaling Lymphocytic Activation Molecule F7), a surface glycoprotein highly expressed on myeloma cells and natural killer (NK) cells. Its mechanism primarily enhances NK cell–mediated cytotoxicity against myeloma cells, offering a novel immunotherapeutic approach. Initially approved as a combination therapy with pomalidomide and dexamethasone, elotuzumab demonstrated efficacy in relapsed/refractory multiple myeloma (RRMM) [1].

Despite its targeted mechanism, elotuzumab's clinical development faced challenges due to moderate response rates compared to other agents. Nonetheless, its immunomodulatory action and favorable safety profile sustain its clinical utility, especially for patients with specific treatment histories or contraindications.

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Market Dynamics

1. Competitive Landscape

The multiple myeloma treatment arena is marked by a surge of novel agents, including proteasome inhibitors (e.g., bortezomib, carfilzomib), immunomodulatory drugs (e.g., lenalidomide, pomalidomide), monoclonal antibodies (e.g., daratumumab, isatuximab), and CAR T-cell therapies (e.g., idecabtagene vicleucel).

Daratumumab, an anti-CD38 monoclonal antibody, rapidly gained market share post-approval, often replacing earlier therapies. Its superior efficacy in various lines of treatment has limited elotuzumab's adoption, relegating it primarily to specific niches.

2. Competitive Positioning

Elotuzumab's niche remains relatively narrow, primarily in combinations for patients refractory to other agents or unable to tolerate more aggressive therapies. Its moderate response rates and infusion-related side effects hinder broad adoption. However, its safety profile—limited myelosuppression and infusion reactions—appeals to certain patient subsets.

3. Regulatory and Labeling Developments

In 2021, the FDA granted Orphan Drug designation to elotuzumab for multiple myeloma, potentially extending exclusivity periods and incentivizing development. Additionally, ongoing trials exploring combination regimens aim to enhance its efficacy [2].

4. Sponsorship and R&D Efforts

AbbVie's continued investment in combination studies and potential next-generation formulations signifies a strategic effort to bolster elotuzumab’s market relevance. Yet, the decline of monotherapy interest reflects a broader shift towards more potent and durable therapies.

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Financial Trajectory

1. Sales Performance

Post-approval, elotuzumab experienced modest sales, constrained by its limited clinical application and competition. According to IQVIA data, peak sales in 2018 reached approximately $150 million globally; however, subsequent declines reflect its niche positioning and transition toward later-line therapies [3].

2. Revenue Drivers

Major revenue streams derive from combination regimens in relapsed/refractory settings. The drug's role as part of multi-drug regimens with pomalidomide/dexamethasone and lenalidomide/dexamethasone sustains some revenue, but overall contribution remains subdued amid newer, more effective options.

3. Cost and Pricing Strategies

Elotuzumab's pricing aligns with baseline monoclonal antibody therapeutics, averaging approximately $10,000 per infusion. Cost management is critical, especially given its restricted use and competitive pressures.

4. Future Revenue Potential

The outlook hinges on ongoing clinical trials assessing elotuzumab in combination with other agents, potentially expanding its indications before patent expirations and biosimilar entries. However, the dominant market share of newer agents tempers optimistic projections.

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Market Outlook

1. Patent and Market Exclusivity

AbbVie's patent protections for elotuzumab are expected to expire by 2025–2026, opening the market to biosimilars and generic competitors. Such entrants could significantly diminish pricing power and sales volume.

2. Emerging Therapies and Market Disruption

The advent of CAR T-cell therapies (e.g., idecabtagene vicleucel, ciltacabtagene autoleucel) and bispecific T-cell engagers (e.g., AMG 420) offers transformative potential, likely overshadowing antibody-based therapies like elotuzumab in front-line and early relapsed settings.

3. Strategic Opportunities

Evolving combination regimens that leverage elotuzumab's immunostimulatory effects may carve a niche, especially for patients with specific genetic profiles or treatment contraindications. Additionally, advanced formulations or synergistic agents could extend its lifecycle.

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Regulatory and Patent Challenges

Anticipated patent cliff and biosimilar entry threaten revenue sustainability. However, patent extensions via supplementary protection certificates (SPCs), and strategic licensing, may delay generic competition. Regulatory agencies' ongoing evaluation of combination therapies indicates potential for expanded indications—though competitive barriers remain high.

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Summary of Financial Trends

Year	Estimated Global Sales	Key Drivers	Challenges
2015	~$120 million	Initial adoption	Limited indications
2018	~$150 million	Expanded combination use	Competitive landscape intensifies
2022	~$80 million	Market saturation, biosimilars looming	Eclipsed by newer therapies

Note: Figures are extrapolated estimates based on industry reports, reflecting global sales trends.

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Conclusion

Elotuzumab’s market trajectory exemplifies the challenges faced by targeted biologics amidst a dynamic, innovation-driven multiple myeloma landscape. While its clinical profile offers specific benefits, market penetration remains limited compared to dominant players like daratumumab. Its future reliance on combination strategies, potential indications, and patent protections will determine its sustained commercial viability. Companies looking to leverage or compensate for obsolescence must consider generics, novel formulations, or combination therapies to extend value.

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Key Takeaways

• Limited market share: Elotuzumab occupies a niche within relapsed/refractory multiple myeloma, hampered by competing agents with higher efficacy.
• Patent expirations: Anticipate biosimilar entries post-2025, exerting downward pressure on prices.
• Clinical positioning: Future growth depends on novel combination trials to improve response rates and expand indications.
• Competitive pressure: The emergence of CAR T-cell therapy and bispecific antibodies poses significant threats to its market relevance.
• Lifecycle management: Strategic investment in formulation improvements, new indications, and partnerships could sustain revenues amid intensifying competition.

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FAQs

1. What are the primary clinical advantages of elotuzumab over other multiple myeloma therapies?
Elotuzumab’s safety profile with minimal myelosuppression and infusion reactions offers advantages for specific patient populations, emphasizing its role in maintenance and combination regimens where tolerability is critical.

2. How will patent expirations impact elotuzumab’s market share?
Patent expirations projected around 2025–2026 will enable biosimilar competition, likely reducing prices and sales volume significantly unless new indications or formulations are developed.

3. Are there ongoing clinical trials that could revive elotuzumab’s relevance?
Yes, several studies are exploring combinations with other immunomodulatory agents and novel therapies, potentially improving efficacy and broadening its clinical applications.

4. How does elotuzumab compare economically to other monoclonal antibodies in multiple myeloma?
It is priced similarly (~$10,000 per infusion) but garners less revenue due to limited usage. Market leaders like daratumumab generate substantially higher sales owing to broader indications and superior efficacy.

5. What strategies can companies employ to extend elotuzumab’s market life?
Investments in combination therapies, developing biosimilars ahead of patent expiry, exploring new indications, and enhancing formulations are critical strategies.

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Sources:

[1] FDA. (2015). FDA approves empliciti, a new targeted therapy for multiple myeloma.
[2] ClinicalTrials.gov. Ongoing trials involving elotuzumab in combination regimens.
[3] IQVIA. (2022). Biologics Market Report.