In the high-stakes world of pharmaceutical competition, timing isn’t just important—it’s everything. Recent research confirms what industry insiders have long suspected: the first generic drug to market after patent expiration enjoys substantial and lasting advantages over later entrants. According to comprehensive market analysis, first movers can capture up to 90% market share advantage that persists for years, creating a considerable competitive edge in an increasingly crowded marketplace. This phenomenon shapes strategic decisions for manufacturers, influences healthcare costs, and impacts patient access to medications. For business professionals navigating the complex pharmaceutical landscape, understanding the mechanisms behind first-mover advantage is critical for successful market positioning, pricing strategies, and ultimately, business success in the generic drug space.
Understanding the Generic Drug Marketplace
The pharmaceutical industry operates under unique market conditions that significantly differ from traditional consumer goods sectors. Generic drugs—bioequivalent alternatives to brand-name medications that enter the market after patent expiration—represent a rapidly growing segment of pharmaceutical sales worldwide.
The Economics of Generic Drug Competition
Generic competition fundamentally transforms pharmaceutical markets by introducing lower-priced alternatives to once-monopolistic brand-name drugs. Unlike typical product markets where competitors can differentiate through features or quality, generic drugs must be bioequivalent to their brand-name counterparts, meeting identical FDA standards for safety, efficacy, and quality. This regulatory requirement creates a market where price becomes the primary competitive factor—at least theoretically.
The generic drug market is projected to reach an astonishing $575 billion globally by 2028, growing at a compound annual growth rate (CAGR) of 5.7%[3]. This growth is driven by healthcare systems seeking cost containment, patent expirations of blockbuster drugs, and increasing acceptance of generics among providers and patients. Despite this growth, generic manufacturers face increasingly challenging economics with shrinking margins due to heightened global regulatory enforcement, rising raw material costs, and intensifying competition[2].
Key Structural Elements of Generic Markets
What makes generic drug markets particularly fascinating is their structural peculiarities. When brand-name drugs lose patent protection—an event industry insiders call the “patent cliff”—multiple generic manufacturers typically prepare to enter the market simultaneously. However, regulatory frameworks like the Hatch-Waxman Act in the United States create unique competitive dynamics.
Under this framework, the first generic manufacturer to successfully challenge a brand-name drug’s patent can receive 180 days of market exclusivity, essentially creating a temporary duopoly between the brand and first generic before other competitors can enter. This regulatory mechanism was designed to incentivize patent challenges and accelerate generic availability, but it also establishes the foundation for first-mover advantage that extends well beyond the exclusivity period.
Regulatory Framework and Market Entry
The path to generic market entry is governed by complex regulatory processes. In the United States, generic manufacturers file Abbreviated New Drug Applications (ANDAs) with the FDA, which may include Paragraph IV certifications challenging the validity or applicability of existing patents. Recent data shows that for high-value drugs (those with annual sales exceeding $250 million), 93% faced at least one such challenge, occurring on average 6.0 years after brand launch[4].
These regulatory challenges create significant barriers to entry, requiring substantial legal and scientific expertise. A successful challenger must not only develop a bioequivalent product but also navigate intricate patent landscapes and potential litigation from brand manufacturers eager to protect their market position.
Pricing Dynamics in the Generic Drug Sector
Generic drug pricing follows unique patterns compared to other industries. The initial generic entrant typically launches at a price point 20-30% below the brand-name product, creating immediate value for payers and patients while maintaining healthy margins for the manufacturer. As additional competitors enter, prices typically decline progressively, with the steepest drops occurring once three or more generics are available.
This price erosion pattern creates an economic imperative to be first to market, as early entrants can establish market position and capture higher margins before full competitive pricing pressure takes effect. A manufacturer’s ability to sustain profitability often depends on capturing substantial market share during this initial period when pricing remains relatively favorable.
The Quantifiable First-Mover Advantage
The first-mover advantage in generic pharmaceuticals isn’t merely theoretical—it’s quantifiable and substantial. Comprehensive market analyses demonstrate clear patterns of advantage that translate directly to business outcomes.
Market Share Disparities Between First and Subsequent Entrants
Research by Yu and Gupta reveals striking disparities in market share between first and subsequent generic entrants. Their analysis found that the first generic entrant into a market enjoys an 80% market share advantage over the second entrant and a remarkable 225% market share advantage over the third entrant[2]. These differences aren’t marginal—they represent fundamental competitive positioning that directly impacts revenue and profitability.
“According to Yu and Gupta, the first generic entrant into a market has an 80% market share advantage over the second entrant, and a 225% market share advantage over the third entrant. Moreover, these advantages last for at least three years.”[2]
This advantage becomes even more pronounced when the first mover achieves significant lead time before competitor entry. When the first generic launches a month or more before competitors, the market share advantage increases substantially, demonstrating the critical importance of not just being first, but being first by a meaningful margin[2].
Duration of First-Mover Advantage Effects
Perhaps most valuable for business planning purposes is the persistence of first-mover advantage over time. Data confirms that these advantages remain substantial for at least three years following market entry[2]. This extended timeframe allows first movers to recoup development costs, establish market presence, and build relationships with key stakeholders before facing full competitive pressure.
McKinsey’s analysis of 492 drug launches across 131 classes over a 27-year period (1986-2012) confirmed that first entrants on average achieve higher market share even ten years after launch[5]. This persistent advantage demonstrates that early market positioning creates effects that competitors struggle to overcome even with substantial marketing investments and competitive pricing.
Financial Implications of Delayed Market Entry
For generic manufacturers, the financial consequences of delayed market entry are substantial. Each month of delay represents lost revenue opportunity during the period when pricing remains highest and market share is most readily captured. In high-value markets, these delays can translate to millions in foregone revenue and significantly reduced return on investment for product development.
The severity of these implications explains why generic manufacturers invest heavily in accelerating development timelines, legal strategies to challenge patents, and regulatory expertise to navigate approval processes efficiently. For business leaders, understanding these dynamics is crucial for portfolio management decisions and resource allocation.
Case Studies of Successful First Generic Launches
Examining specific market examples illustrates the magnitude of first-mover advantage. When the first generic version of the cholesterol medication atorvastatin (Lipitor) launched, it captured over 70% of the genericized market within months. Similar patterns emerged with generic versions of other blockbuster medications like escitalopram (Lexapro) and olanzapine (Zyprexa), where first movers secured dominant market positions that later entrants struggled to challenge.
These real-world examples demonstrate that theoretical advantages translate into measurable business outcomes, reinforcing the strategic importance of winning the race to market in generic pharmaceutical competition.
Factors Contributing to First-Mover Advantage
The substantial and persistent advantages enjoyed by first generic entrants stem from multiple interconnected factors that create powerful market dynamics. Understanding these mechanisms provides crucial insights for strategic planning.
Pharmacy and Wholesaler Purchasing Behaviors
One of the most significant drivers of first-mover advantage lies in the purchasing patterns of pharmaceutical wholesalers and retail pharmacies. Unlike consumer markets where end-users actively select between competing products, generic drug selection typically occurs at the institutional level, with pharmacies and wholesalers making stocking decisions that effectively determine which generic version patients receive.
The first generic to market typically secures preferential positions in wholesaler and pharmacy distribution channels for several compelling reasons:
Inventory management efficiency: Pharmacies prefer stocking a single generic version for each medication to minimize inventory costs and complexity. The first generic available naturally becomes the default choice.
Contractual relationships: Early entrants can establish supply agreements and formulary positions that create structural barriers for later entrants.
System integration: Once a generic is integrated into pharmacy ordering systems, inventory management software, and dispensing protocols, there’s significant inertia against switching to alternatives.
Risk aversion: Wholesalers and pharmacies develop confidence in reliable supply from the first entrant, making them hesitant to switch to untested suppliers.
These institutional dynamics create powerful path dependencies that benefit the first mover, even when later entrants offer modest price advantages.
Patient Reluctance to Switch Medications
Patient behavior significantly reinforces first-mover advantage through reluctance to switch between different generic versions of the same medication. This reluctance stems from several factors:
First, patients often develop comfort and confidence in medications based on appearance, packaging, and brand association. When patients begin therapy with the first available generic, they typically prefer to maintain consistency rather than switch to alternative versions, even when bioequivalent.
Research in the Canadian market has specifically identified “patients’ unwillingness to switch between generic medications” as a key factor driving first-mover advantage[1]. This psychological factor creates persistent demand for the first generic version that pharmacies and prescribers must accommodate.
Physician Prescribing Patterns
Physician behavior also contributes significantly to first-mover advantage. Doctors develop familiarity with specific generic products through initial prescribing experiences, creating cognitive defaults that influence subsequent decisions. Research shows that physicians incur “search and persuasion costs” when considering alternative generic options, creating inertia that benefits established first movers[1].
Additionally, physicians receive feedback from patients about medication experiences. When patients begin therapy with the first generic and report positive outcomes, physicians have little incentive to recommend alternatives. This reinforcement cycle strengthens the position of first entrants over time.
Administrative and Stocking Considerations for Pharmacies
For pharmacies, the first generic to market often becomes the standard stocking choice due to practical business considerations beyond simple purchasing decisions. Research has identified “additional administrative costs of pharmacies when stocking several identical generic drugs with no real monetary incentives” as a barrier to multi-generic stocking[1].
These administrative costs include:
Shelf space optimization: Pharmacies have limited physical space and prefer dedicating it to different medications rather than multiple versions of the same generic.
Training requirements: Pharmacy staff must be familiar with all stocked products; limiting generic options reduces training needs.
Inventory management complexity: Each additional generic version increases ordering, stocking, and inventory management burdens.
Patient confusion management: Pharmacies must address patient questions and concerns about different-appearing generics, creating service challenges when stocking multiple versions.
These practical business considerations create strong incentives for pharmacies to select a single generic supplier—typically the first available—and maintain that relationship unless compelling reasons for change emerge.
Strategic Considerations for Market Entry Timing
Given the substantial advantages of being first to market, generic manufacturers must develop sophisticated strategies to optimize market entry timing. These strategies balance legal, regulatory, commercial, and operational considerations.
Patent Challenge Strategies and the Hatch-Waxman Act
The Hatch-Waxman Act creates a legal framework that shapes generic competition through its Paragraph IV certification process, which allows generic manufacturers to challenge existing patents. Recent data shows that for high-value drugs (>$250 million in annual sales), 93% faced at least one such challenge, occurring on average 6.0 years after brand launch—with these drugs facing an average of 8.9 Paragraph IV challengers[4].
Successful generic manufacturers develop comprehensive patent challenge strategies that consider:
Patent landscape analysis: Identifying weaknesses in patent protection and opportunities for non-infringement arguments.
Litigation risk assessment: Evaluating the probability of successful challenges against the costs of potential litigation.
First-filer positioning: Strategies to secure the coveted first-to-file status that can lead to 180-day exclusivity.
Settlement evaluation: Analyzing potential benefits of patent litigation settlements versus continued legal challenges.
The increasing frequency and earliness of patent challenges demonstrates the growing recognition of first-mover advantage value. Manufacturers increasingly invest in legal strategies to accelerate market entry, even when facing significant litigation risk from brand manufacturers.
Risk Assessment for Generic Drug Developers
Generic manufacturers must conduct sophisticated risk assessments when planning market entry strategies. These assessments balance multiple factors:
Development investment: The costs of product development, bioequivalence studies, and regulatory submissions.
Litigation expenses: Legal costs for patent challenges, which can reach millions of dollars for complex products.
Manufacturing readiness: Ensuring production capacity is available to capitalize on market entry opportunities.
Potential returns: Projecting revenue based on market size, pricing evolution, and anticipated market share.
The calculus becomes particularly complex for products with multiple potential generic entrants. Game theory considerations emerge as companies must anticipate competitor moves and counter-strategies from brand manufacturers, such as authorized generic launches that can significantly impact market dynamics.
Balancing Speed to Market with Quality Assurance
While speed to market creates substantial advantages, generic manufacturers must balance acceleration against quality and compliance requirements. Regulatory submissions with deficiencies can result in delays that eliminate first-mover advantages, making thorough development and documentation essential.
Successful manufacturers develop systematic approaches to parallel-track development activities, streamline internal review processes, and invest in regulatory affairs expertise to optimize submissions. These operational capabilities increasingly differentiate successful first movers from competitors who may develop bioequivalent products but face delays in regulatory approval.
Resource Allocation for Accelerated Development
Given the value of first-mover advantage, leading generic manufacturers strategically allocate additional resources to high-priority development programs with significant first-mover potential. These investments may include:
Enhanced analytical capabilities: To accelerate formulation development and bioequivalence testing.
Specialized regulatory teams: Dedicated to high-priority submissions and rapid response to FDA questions.
Manufacturing readiness investments: Ensuring production capacity is validated and available immediately upon approval.
Legal resources: Concentrated on patent challenges with first-to-file potential.
These resource allocation decisions represent strategic bets on the value of first-mover advantage, with companies accepting higher development costs in exchange for accelerated timelines and increased probability of being first to market.
Building a Successful Generic Drug Launch Strategy
Capturing first-mover advantage requires more than simply being first to market—it demands a comprehensive launch strategy that maximizes the value of early entry and establishes sustainable competitive positioning.
Market Research and Opportunity Identification
Successful generic manufacturers begin with rigorous market assessment to identify high-potential opportunities. This assessment includes:
Patent expiration analysis: Mapping upcoming patent expirations and evaluating the strength of patent protection.
Market size evaluation: Projecting the potential genericized market based on current brand sales and therapeutic category dynamics.
Competitive intelligence: Assessing likely competitors, their capabilities, and probable strategies.
Barrier assessment: Identifying potential obstacles including complex formulations, controlled substances restrictions, or specialized distribution requirements.
This comprehensive analysis allows manufacturers to prioritize development programs based on both technical feasibility and commercial potential, focusing resources where first-mover advantage offers the greatest value.
Competitive Positioning Strategies
While first-mover status provides inherent advantages, manufacturers must still develop deliberate positioning strategies to maximize these benefits. Effective positioning considers:
Supply reliability: Establishing reputation for consistent supply is critical for maintaining pharmacy and wholesaler relationships.
Quality differentiation: Even with bioequivalent products, manufacturers can differentiate through packaging, tablet appearance, and support services.
Stakeholder engagement: Building relationships with key pharmacy chains, wholesalers, and pharmacy benefit managers.
Customer service excellence: Providing superior ordering, delivery, and support experiences compared to later entrants.
These positioning elements strengthen the natural advantages of being first to market, creating additional switching costs that later entrants must overcome to gain share.
Pricing Strategies for Market Penetration
Pricing represents a critical strategic decision for first generic entrants. Optimal pricing balances several objectives:
Maximizing initial revenue: Capturing value during the limited competition period.
Discouraging later entry: Strategic pricing can reduce market attractiveness for potential competitors.
Securing institutional contracts: Establishing agreements with key purchasers that create barriers to competitor penetration.
Building market share: Pricing to maximize unit volume and establish dominant position.
First movers typically launch at price points 20-30% below brand pricing, creating immediate savings for payers while maintaining healthy margins. This approach delivers value to the healthcare system while capitalizing on temporary competitive advantage before additional entrants drive more aggressive price competition.
Distribution and Supply Chain Optimization
Distribution capabilities significantly impact first-mover advantage realization. Manufacturers must ensure:
Broad availability: Product must be immediately available through all major wholesalers and distribution channels.
Inventory placement: Strategic inventory positioning to enable rapid fulfillment nationwide.
Production scalability: Manufacturing capacity must accommodate rapid demand increases as conversion from brand accelerates.
Supply chain security: Robust supply chain management to prevent stockouts that could create opportunities for competitors.
These operational capabilities translate market entry timing into sustained competitive advantage by ensuring the first mover can fully satisfy market demand from day one of launch.
The Evolving Landscape of Generic Competition
While first-mover advantage remains powerful, the competitive landscape for generic pharmaceuticals continues to evolve, creating new dynamics that manufacturers must navigate.
Impact of Authorized Generics on First-Mover Advantage
One significant evolution in generic competition is the increasing prevalence of authorized generics (AGs)—generic versions of brand-name drugs marketed by the brand manufacturer or its partner. Research shows that branded firms strategically use AGs to protect market share and influence generic competition dynamics.
When first-mover advantage is sufficiently large, “the branded firm is better off in a triopoly with an AG than in a competitive duopoly”[1]. This creates complex competitive scenarios where the first independent generic faces not only the brand but also an authorized generic with identical formulation to the brand and potentially preferential supply chain positioning.
The presence of AGs can significantly impact the magnitude of first-mover advantage for independent generics, though research indicates that substantial advantages persist even in markets with authorized competition. This dynamic requires generic manufacturers to anticipate AG strategies in their market entry planning and competitive positioning.
Changes in Market Exclusivity Periods Over Time
The duration of market exclusivity periods (MEPs)—the time between brand launch and first generic entry—significantly influences generic competition dynamics. Recent research shows that for drugs with sales greater than $250 million experiencing initial generic entry in 2017-19, the MEP was 13.0 years, while the overall average MEP was 14.1 years[4].
Interestingly, this analysis found that MEPs “changed relatively little over the past decade”[4], suggesting stability in the fundamental patent protection and generic challenge timelines despite increasing patent challenge activity. This stability provides a relatively predictable planning horizon for generic manufacturers developing pipeline strategies.
Emerging Markets and Global Generic Strategies
While first-mover advantages have been extensively documented in established markets like the United States and Europe, similar dynamics are increasingly evident in emerging pharmaceutical markets. As pharmaceutical regulation matures globally, the patterns of generic competition observed in developed markets are replicated with local variations.
For multinational generic manufacturers, this creates opportunities to leverage development investments across multiple markets, potentially capturing first-mover advantages in multiple regions with staggered launches based on patent expiration timing and regulatory approval sequences.
Digital Transformation in Generic Drug Marketing
Digital technologies are transforming pharmaceutical marketing, creating new dimensions of competition beyond traditional first-mover dynamics. Generic manufacturers increasingly employ digital channels to:
Enhance prescriber awareness: Digital communication with healthcare providers about generic availability and attributes.
Support patient transitions: Apps and online tools to facilitate switches from brand to generic medications.
Streamline pharmacy ordering: B2B platforms that simplify procurement processes for pharmacies.
Monitor market dynamics: Advanced analytics to track competitor activities and market developments.
These digital capabilities represent an evolution in how first-mover advantage manifests, creating new mechanisms to strengthen early market position through information advantage and enhanced stakeholder engagement.
Future Trends in Generic Drug Competition
Looking ahead, several emerging trends will likely shape the evolution of first-mover advantage in generic pharmaceutical markets.
Advancing technologies are changing traditional generic development paradigms. Innovations in areas such as:
Advanced analytics: Predictive modeling of bioequivalence outcomes to accelerate formulation development.
Artificial intelligence: Application to patent analysis, formulation optimization, and regulatory submission preparation.
Continuous manufacturing: Technologies enabling more flexible and efficient production scaling.
Bioequivalence simulation: Reducing clinical study requirements through in-silico modeling.
These innovations may compress development timelines while reducing costs, potentially intensifying competition for first-to-market position while enabling smaller companies to compete more effectively with established players.
Accelerated review pathways: Initiatives like the FDA’s GDUFA (Generic Drug User Fee Amendments) prioritization of certain applications.
Regulatory harmonization: Increasing alignment between regulatory requirements across major markets.
Patent reform discussions: Ongoing debates about patent thickets, evergreening, and potential legislative responses.
Transparency initiatives: Greater visibility into patent listings, certification status, and approval timelines.
These regulatory developments may alter the timing and predictability of generic entry opportunities, requiring manufacturers to develop more sophisticated regulatory strategies to maintain first-mover positioning.
Consolidation and Collaboration in the Generic Space
Industry structure continues to evolve through consolidation, with larger generic manufacturers acquiring smaller competitors to gain scale advantages in development, manufacturing, and distribution. This consolidation may influence first-mover dynamics by:
Concentrating resources: Enabling larger investments in accelerated development for key opportunities.
Reducing competitor numbers: Potentially decreasing the intensity of competition for first-to-file positions.
Creating portfolio synergies: Allowing strategic coordination across multiple product launches.
Simultaneously, novel collaboration models are emerging, with partnerships between generic developers, contract research organizations, and specialized legal firms creating virtual integrated development capabilities that can accelerate time-to-market.
The Role of Biosimilars in Changing Competitive Patterns
The growing importance of biological products and their follow-on biosimilars introduces new dimensions to first-mover advantage dynamics. Biosimilar development requires substantially greater investment and technical capability than traditional small-molecule generics, potentially amplifying first-mover advantages by:
Creating higher entry barriers: The complexity and cost of biosimilar development limit competitor numbers.
Extending development timelines: Longer biosimilar development cycles may increase the gap between first and subsequent entrants.
Intensifying stakeholder education needs: First biosimilar entrants must invest in market development activities that benefit later entrants.
These factors suggest that first-mover advantages may be even more pronounced in biosimilar markets than in traditional generic segments, with important strategic implications for manufacturers considering investments in this growing area.
Key Takeaways
The evidence overwhelmingly confirms that being first to market with a generic drug creates substantial and lasting competitive advantages. Key insights for pharmaceutical business professionals include:
Quantifiable advantage: First generic entrants enjoy market share advantages of 80% over second entrants and 225% over third entrants, with benefits persisting for at least three years.
Structural drivers: First-mover advantage stems from pharmacy stocking decisions, patient reluctance to switch medications, physician prescribing habits, and administrative efficiencies.
Strategic imperative: Given the magnitude of first-mover benefits, manufacturers should prioritize development speed and patent challenge strategies to maximize first-to-market opportunities.
Evolving landscape: While first-mover advantage remains powerful, dynamics continue to evolve through authorized generics, regulatory changes, digital transformation, and industry consolidation.
Future outlook: Technological innovations, regulatory developments, and the rise of biosimilars will shape future competitive patterns, potentially amplifying first-mover advantages in certain segments.
For generic manufacturers, these insights underscore the critical importance of pipeline selection, development efficiency, regulatory strategy, and launch execution in capturing the substantial value created by first-mover advantage.
FAQs About First-Mover Advantage in Generic Drug Markets
How much more market share does the first generic typically capture compared to later entrants?
Research shows that the first generic entrant enjoys an 80% market share advantage over the second entrant and a remarkable 225% market share advantage over the third entrant. This advantage can represent up to 90% of the total genericized market and persists for at least three years after initial launch. The advantage becomes even more pronounced when the first mover achieves a lead time of one month or more before competitor entry.
Why do pharmacies tend to stock the first generic available rather than waiting for multiple options?
Pharmacies prefer stocking the first generic available due to several business considerations. These include inventory management efficiency (minimizing the number of identical products), reduced administrative costs, limited shelf space, streamlined staff training requirements, and the desire to avoid patient confusion. Once a pharmacy establishes inventory and dispensing processes for the first generic, switching to alternatives creates operational challenges with limited financial incentives.
How does the Hatch-Waxman Act influence first-mover advantage in the United States?
The Hatch-Waxman Act creates a regulatory framework that significantly influences first-mover advantage through its Paragraph IV certification process. This allows generic manufacturers to challenge existing patents before expiration. The first successful challenger can receive 180 days of market exclusivity, creating a powerful incentive for being first to file and first to market. Recent data shows that 93% of high-value drugs face Paragraph IV challenges, with these occurring on average 6.0 years after brand launch.
What strategies can generic manufacturers employ to maximize first-mover advantage?
Generic manufacturers can maximize first-mover advantage through comprehensive strategies including: accelerated development timelines with parallel-track activities; sophisticated patent challenge strategies to secure first-to-file status; optimized regulatory submissions with specialized teams for rapid agency interactions; strategic pricing to capture value while discouraging later entry; robust supply chain management to ensure immediate nationwide availability; and stakeholder engagement programs targeting wholesalers, pharmacy chains, and prescribers.
How might first-mover advantage differ for biosimilars compared to traditional generic drugs?
First-mover advantage is likely more pronounced for biosimilars than traditional generic drugs due to several factors. Biosimilar development requires substantially greater investment and technical capability, creating higher entry barriers and limiting competitor numbers. The complexity of biologics leads to extended development timelines, potentially increasing the gap between first and subsequent entrants. Additionally, first biosimilar entrants must invest heavily in stakeholder education and market development activities, which may benefit later entrants but create significant cost differentials and market positioning advantages.
CRESSE, “Pay-for-delay deals and authorized generics,” https://www.cresse.info/wp-content/uploads/2020/02/2018_ps4_pa5_Entry-limiting.pdf
DrugPatentWatch, “First Generic Launch has Significant First-Mover Advantage Over Later Generic Drug Entrants,” https://www.drugpatentwatch.com/blog/first-generic-launch-has-significant-first-mover-advantage-over-later-generic-drug-entrants/
DrugPatentWatch, “How to Implement a Successful Generic Drug Launch Strategy,” https://www.drugpatentwatch.com/blog/how-to-implement-a-successful-generic-drug-launch-strategy/
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