Kamini Anbil

Historically, new drugs were approved for a single therapeutic use. However, industry trends have shifted, with pharmaceutical companies increasingly identifying and developing additional indications for existing medicines. This approach is supported by regulatory agencies such as the FDA and EMA, which recognize the value of leveraging established safety profiles for new uses.

As a result, the number of expanded indications for drugs has nearly doubled in the past decade. Platform drugs—those whose core technology can be adapted for multiple indications—are especially attractive. Once a drug’s safety is established for its first indication, regulatory risks for additional approvals are reduced, making this a cost-effective way to bring new therapies to market.

Branding strategies: Single versus multiple brands

Choosing between a single brand or multiple brands for a drug with several indications is a complex and high-stakes decision. The optimal approach depends on several factors. The regulatory environment plays a key role; the FDA is generally cautious about multiple brand names for the same molecule, primarily due to concerns about medication errors and overdosing. Multiple brands may be permitted if there is stigma associated with one indication, significant dosage differences, or low comorbidity between indications.

The EMA is more flexible, allowing different trademarks for new marketing authorizations if justified by public health or co-marketing needs, though applicants must justify the need for multiple brands and demonstrate how patient safety will be maintained.

Therapeutic area differences also influence branding decisions. If indications are closely related—such as within the same therapeutic class—a single brand is often preferred. Conversely, if indications are unrelated or have significant differences in patient populations, dosing, or disease severity, multiple brands may be more appropriate. Patient safety and social stigma are additional considerations; dual branding can help avoid confusion and reduce the risk of overdose, especially when dosing or patient populations differ significantly. It can also help mitigate social stigma associated with specific indications, such as erectile dysfunction.

Drugs with closely related indications often use one brand, while those treating distinct conditions may benefit from dual branding to address safety, stigma, or dosing differences.

The FDA is generally cautious about multiple brand names for the same molecule, while the EMA allows them when justified by public health needs or marketing strategy.

Identifying future indications early, coordinating cross-functional teams, and leveraging advanced analytics are critical to optimizing branding decisions and maximizing commercial success.

Classic examples illustrate the application of these strategies. For instance, Cialis (tadalafil) is marketed for erectile dysfunction, while Adcirca (also tadalafil) is used for pulmonary arterial hypertension. The rationale for dual branding includes unrelated therapeutic areas, different patient populations, stigma associated with erectile dysfunction, and significant dosage differences. Similarly, Viagra (sildenafil) is indicated for erectile dysfunction, while Revatio (also sildenafil) is used for pulmonary arterial hypertension. The same reasoning applies to different dosing and patient populations, leading to the use of two distinct brands to differentiate indications and manage stigma.

In contrast, Enbrel (etanercept) is used for both rheumatology and dermatology autoimmune diseases. Because these indications are closely related, a single brand is maintained across uses, leveraging the established reputation and safety data.

Recent examples further highlight these considerations. Humira (adalimumab) is prescribed for multiple autoimmune indications, including rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis. A single brand is used across all indications, reinforcing market leadership and the safety profile due to overlapping prescribers and consistent dosing. Keytruda (pembrolizumab) is another example of a single brand maintained across multiple oncology indications, including melanoma, non-small cell lung cancer, and head and neck cancer, due to its broad use across various cancer types and similar dosing and administration.

Ozempic (semaglutide) is indicated for type 2 diabetes, while Wegovy (also semaglutide) is used for chronic weight management. The use of two distinct brands helps differentiate between diabetes and weight management, addressing regulatory and safety concerns, even though patient populations may overlap. Prolia (denosumab) is used for osteoporosis, while Xgeva (also denosumab) is indicated for cancer-related bone complications. Dual branding reflects distinct clinical needs and dosing regimens.

Similarly, Zometa (zoledronic acid) is used for cancer-related bone complications, and Reclast (also zoledronic acid) is indicated for osteoporosis, with dual branding helping to avoid confusion and ensure appropriate use.

Strategic considerations and operational challenges

When adopting a single-brand approach, it is important to identify all potential indications early to choose a versatile trademark. Sales and marketing efforts must be coordinated across indications, especially if targeting primary care physicians. Developing a unified brand character and clear communication about the drug’s mechanism across indications is essential. Sales and medical teams should be trained to address questions about all indications.

For a multi-brand approach, it is essential to engage regulatory authorities early in the development process. Managing global trademark availability and protection can be complex and costly. Separate brand teams and plans may be necessary, but maintaining cross-functional collaboration is crucial.

Pricing and inventory must be monitored for each brand, particularly if doses overlap or differ. Clear implementation plans and resources should be provided for regional affiliates.

Understanding treatment patterns at the facility level is critical for optimizing resource allocation and identifying growth opportunities for multi-indication drugs. Sales figures alone may not reveal which indications are driving growth, highlighting the need for advanced analytics to inform strategy.

Overall, pharmaceutical companies must carefully weigh regulatory, commercial, and operational factors when deciding between single-brand and multiple-brand strategies for drugs with multiple indications. Classic examples such as Cialis/Adcirca and Viagra/Revatio demonstrate the importance of therapeutic area differences, patient populations, and stigma. Recent cases, including Humira, Keytruda, Ozempic/Wegovy, Prolia/Xgeva, and Zometa/Reclast, highlight the ongoing relevance of these considerations in today’s market. Early planning, clear communication, and data-driven insights are crucial for maximizing value and ensuring patient safety.

The views expressed in the article are those of the authors and not of the organizations they represent.

Partha Anbil is at the intersection of the life sciences industry and data & analytics, including GenAI/ML/NLP. He is a Senior Advisor to NextGen Invent Corporation, an AI, data analytics, and digital transformation company. He has over 25 years of experience in the industry.

Kamini Anbil is an experienced consultant in the life sciences industry. She spent six years with ZS Associates, a top boutique global management consulting and technology firm specializing in the Life Sciences sector.

Articles

As drug development increasingly targets multiple indications, pharma companies must make strategic branding decisions—balancing regulatory requirements, market dynamics, and patient safety—to choose between single-brand or multi-brand approaches.

Multi-Indication Drug Branding in Today’s Pharmaceutical Industry

: Traditional sales tactics are outdated—collaboration with IDNs is now essential.

: Pharma needs to show measurable clinical and economic impact aligned with health system priorities.

: Success depends on tailored, cross-functional teams and co-created solutions.

The US healthcare landscape has dramatically transformed, accelerating trends that began a decade ago. The convergence of value-based care, digital health, and regulatory changes has fundamentally altered how life sciences companies must engage with integrated delivery networks (IDNs) and health systems. The traditional pharmaceutical commercial model, reliant on volume-driven sales, broad promotional campaigns, and key account management, has lost effectiveness in a market now dominated by consolidated provider organizations, standardized formularies, and outcomes-based reimbursement.

To remain relevant and competitive, pharmaceutical companies must move beyond incremental adjustments and embrace a systematic, partnership-driven approach to health system engagement.

This shift requires answering four foundational questions:

What is our differentiated value proposition for integrated health systems?

How do we identify and prioritize the right system partners?

What does successful, measurable collaboration look like?

How should we redesign our engagement model for long-term, mutual benefit?

Companies that act now to build robust, partnership-based engagement models will be best positioned to thrive as the US health economy continues its shift toward integrated, outcomes-driven care.

Opportunity and challenge in today’s market

The rapid consolidation among providers, spanning physicians, hospitals, and health plans has created formidable barriers for traditional pharmaceutical field teams. Access to decision-makers is tightly controlled, and the influence of individual prescribers has waned as care pathways and digital formularies dictate therapeutic choices. The widespread adoption of electronic health records (EHRs), AI-driven clinical decision support, and population health management tools further diminishes the impact of conventional sales and marketing tactics.

Simultaneously, the vertical integration of retail pharmacy, specialty distribution, and pharmacy benefit managers (PBMs) has eroded the leverage pharmaceutical companies once held through contracting. Health systems now demand clear, evidence-based demonstrations of clinical and economic value, ideally supported by real-world evidence (RWE) and digital health solutions that drive measurable improvements in patient outcomes.

While many pharmaceutical leaders recognize these shifts, few have developed actionable, system-oriented engagement strategies. Treating IDN engagement as an extension of key account management or focusing solely on cost-offset models fails to address the fundamental changes in health system economics and priorities. A new approach, rooted in partnership, data, and shared outcomes, is now essential.

Redefining the value proposition for integrated health systems

The provider business model has shifted decisively from volume-based to value-based care. Health systems are now evaluated on their ability to deliver better outcomes at lower costs, as measured by quality scores, population health metrics, and risk-based reimbursement contracts.

Pharmaceutical companies must align their value propositions with these priorities, moving beyond efficacy and safety to demonstrate how therapies improve disease-specific and population health outcomes; the impact of interventions on total cost of care (e.g., reducing hospitalizations, emergency visits, or surgical interventions); integration with digital health tools and care pathways to support adherence, remote monitoring, and patient engagement; and the ability to generate and share RWE that supports continuous improvement and regulatory compliance.

Discounting alone is unsustainable. Instead, pharma must be willing to tie reimbursement or contracting terms to real-world performance, sharing risk and reward with health system partners. This means developing value propositions that:

Connect drug utilization to expected clinical effects across all relevant service lines

Offer clear, measurable improvements in outcomes based on tangible interventions

Aligning with metrics that matter to providers (e.g., disease-specific outcomes, Triple Aim, quality scores)

Translate clinical gains into cost offsets or revenue upside for the health system

For example, a cardiovascular drug’s value should be assessed within the entire cardiovascular service line, considering its impact on hospitalizations and long-term health costs. Similarly, high-cost therapies for chronic diseases must demonstrate their ability to reduce downstream expenses, such as emergency care or surgical interventions.

Identifying and prioritizing the right partners

Integrated health systems are highly variable in structure, mission, and digital maturity. Effective partner identification requires a nuanced, data-driven approach that considers degree of integration (such as ownership of health plans, breadth of service lines, HER, and analytics capabilities); strategic priorities (e.g., population health, specialty care, digital transformation); decision-making structures (centralized vs. decentralized, clinical vs. administrative leadership); and willingness and capacity for innovation and collaboration.

For instance, large academic medical centers may offer tightly integrated, service-line-driven decision-making, while distributed community hospital networks may rely more on corporate leadership and local market dynamics. The system’s mission, local provider landscape, and financial alignment with physicians all influence the feasibility and structure of potential collaborations.

Mapping these factors enables pharmaceutical companies to prioritize partnerships with systems most likely to benefit from and co-invest in collaborative programs, rather than simply targeting those with the highest sales volume.

Defining and measuring successful collaboration

Success in health system collaboration is defined by the alignment of long-term objectives and the ability to measure and communicate mutual value. Effective collaborations typically fall into one or more of the following categories:

Direct operational cost improvement (e.g., reducing readmissions, optimizing drug utilization)

Joint research and RWE generation (e.g., pragmatic trials, outcomes studies)

Digital health and care coordination support (e.g., remote monitoring, patient engagement platforms)

Clinical pathway co-development (e.g., AI-driven protocol optimization)

Each partnership should be designed to produce tangible, publishable results that can inform broader system strategy and regulatory compliance. For pharmaceutical companies, benefits include improved access, brand differentiation, and risk mitigation as health systems gain greater influence over drug selection and utilization.

The business case for investment in these partnerships extends beyond immediate sales. Durable collaborations can secure formulary access, foster clinical momentum, and create operational integration that is difficult for competitors to displace. Moreover, investing in these relationships allows companies to navigate ongoing system reforms and evolving market dynamics.

Legacy engagement models—fragmented by channel and focused on sales volume—are increasingly obsolete. The new model requires cross-functional teams with expertise in clinical science, data analytics, digital health, and value-based contracting. It also calls for incentive structures aligned with partnership objectives (e.g., outcomes achieved, program adoption, RWE generated), and adaptive engagement strategies tailored to the structure and maturity of each health system partner.

One also cannot forget about the regular, structured input from health system stakeholders to co-design and refine initiatives.

For example, academic medical centers may require highly scientific, research-oriented teams, while community-based systems may benefit from teams skilled in operational improvement and local relationship-building. Internal management structures should mirror the organization and objectives of the health system partner, whether service-line, research, or population health-focused.

Crucially, pharmaceutical companies must proactively seek input from system partners in shaping engagement models, objectives, and tactics. This collaborative approach transforms the relationship from adversarial to mutually beneficial, positioning industry representatives as resources to achieve shared goals.

Organizational implications and the path forward

The transition to partnership-based engagement is a significant undertaking, requiring new capabilities, organizational structures, and cultural change within pharmaceutical companies. Early adopters will be able to shape the future of healthcare delivery, while those who delay risk being sidelined as health systems consolidate purchasing power and clinical decision-making.

The shift from promotion to partnership is now a defining trend in US healthcare. Pharmaceutical companies that embrace this reality by building system-oriented value propositions, prioritizing the right partners, designing measurable collaborations, and reinventing their engagement models will secure a durable competitive advantage in the evolving health economy. The time for action is now; those who move decisively will shape the next healthcare innovation and delivery era.

In order to succeed in today’s outcomes-driven healthcare landscape, pharmaceutical companies must move from traditional sales models to strategic, measurable partnerships with integrated delivery networks (IDNs).