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Institute of Pharmaceutical Sciences and Research, Mahadev Campus, Lucknow-Kanpur Express Highway, Sohramau, Unnao, UP 209859
The pharmaceutical world is a fast-moving environment where new and better medicines are always coming out, making it hard for any single drug to stay on top for long. Product Life Cycle Management (PLCM) is an important concept that helps pharmaceutical companies manage their products from development to decline in a systematic and strategic manner. Every pharmaceutical product passes through different stages such as introduction, growth, maturity, and decline, and each stage requires different marketing and management strategies to ensure sustainability and profitability. This review examines Product Life Cycle Management (PLCM), the strategic framework used by pharmaceutical companies to maximize the value and clinical utility of a drug from its initial release to its eventual market exit. Among these stages, managing aging products is considered the most challenging due to patent expiry, increasing competition from generic drugs, declining demand, and the availability of newer and more effective therapies that replace older treatments. Aging products still hold significant market value and can generate stable revenue if managed properly using appropriate strategies. Various lifecycle extension approaches such as reformulation, repositioning, line extension, branding, pricing strategies, and digital marketing are used to maintain the relevance of pharmaceutical products in the market. This study emphasizes that effective lifecycle management not only benefits pharmaceutical companies in terms of profitability but also contributes to improved healthcare delivery.
Product Lifecycle Management (PLM) is basically the way a pharmaceutical product is managed throughout its entire life. It starts from the early stages like discovery and testing in the lab, then moves through clinical trials and getting approval from regulatory authorities. After that, it includes launching the product in the market, tracking its growth and performance, and handling the later stages when demand slows down or generic versions enter the market [1]. This overall approach helps the company create long-term value by making sure different teams— like research and development (R&D), manufacturing, regulatory, supply chain, and marketing work together smoothly. By coordinating all these functions, companies can reduce risks such as losing patents (known as “patent cliffs”) and deal better with changing market conditions [1,2]. In pharmaceutical marketing, PLM is very important because it helps companies get the best return on their investment (ROI). It does this by adjusting things like promotions, pricing, and how they connect with doctors based on each stage of the product’s life. For example, they focus on creating awareness when the product is newly launched, increasing its use during the growth stage, protecting its market share when it becomes well established, and managing its phase-out properly when demand starts to decline [2,3]. Effective PLM helps a product stay successful for a longer time. Companies do this by making improvements like new formulations, finding new uses for the drug, or creating better delivery systems (this is called “evergreening”). At the same time, they adjust to challenges like strict regulations, pricing pressure from insurers, and competition from other brands. All of this helps make the medicine more accessible to patients while also maintaining the brand’s value and reputation [1,4].
PRODUCT LIFE CYCLE
The product lifecycle in the pharmaceutical industry refers to the complete journey of a drug, from its initial idea to its eventual withdrawal from the market. This process usually takes around 10–15 years or even longer and is divided into different stages. Each stage helps guide the drug’s development, marketing, and overall management [1]. Each stage comes with its own challenges and opportunities, so companies need to use different approaches in research and development, regulatory work, manufacturing, and marketing. This helps them achieve better business success while also ensuring that patients benefit from the medicine [2].
Development Stages (Pre-Launch)
These are the early stages that focus on testing the drug and getting approval before it is launched in the market [1,5].
Commercialization Stages (Post-Launch)
After the drug gets approval, it goes through four main marketing stages that focus on increasing sales and maintaining profits [2,6].
Decline: Sales start to decrease due to patent expiry and the entry of cheaper generic drugs. Companies handle this by offering price reductions, improving the product (like better delivery forms), or shifting their focus to newer medicines [2,3]
Fig.: Product lifecycle Graph
PRODUCT LIFE CYCLE MANAGEMENT (PLCM)
Product Lifecycle Management (PLM) in the pharmaceutical industry is a planned approach that manages a drug throughout its entire life, from its discovery to the time after its patent expires. It helps companies improve profits, keep the product in the market for a longer time, and follow all necessary rules and regulations [1]. Unlike simply tracking a product’s life stages, PLM requires active planning and teamwork from the very beginning. Different teams like R&D, regulatory, manufacturing, medical, and marketing work together to handle challenges such as patent expiry, competition from generic and similar products, and pricing pressure from payers. At the same time, they also focus on opportunities like finding new uses for the drug or improving how it is delivered [2,3]. Effective PLM helps companies avoid sudden drops in revenue and instead maintain profits for a longer time. It can extend the product’s earning period, sometimes adding extra years of value even after patent challenges, and also supports the development of future products [1,4].
Pre-Launch Planning (Discovery to Approval)
PLM starts many years before the drug is launched. Companies plan how to protect their product by filing extra patents for things like new formulations, methods of use, or special groups (like children). They may also apply for special benefits like orphan drug status or fast-track approval [1,5]. At the same time, marketing teams prepare for launch by identifying key doctors, forming advisory groups, and collecting real-world data to support future uses of the drug [2].
Launch & Growth Acceleration
After the drug is approved, PLM focuses on increasing its use quickly [2]. Companies may introduce improved versions of the drug, use digital platforms to connect with doctors, and provide support programs for patients[3,6]. They also plan market access strategies for insurers and gradually expand the drug’s use for different conditions to increase sales[4].
Maturity Defense & Share Protection
When the drug reaches peak sales, the focus shifts to protecting its market position. Companies use strategies like competitive pricing, discounts, patient support programs, and improved versions of the drug (for example, long-acting forms instead of regular ones) [2,7]. They also use data to monitor market trends and respond quickly to competition [5].
Loss of Exclusivity & Transition
When patents expire and cheaper generic drugs enter the market, sales start to decline. To manage this, companies may offer discounts, shift patients to newer drugs, partner with generic companies, or expand into other countries [1,3]. They also continue studies to collect more safety and effectiveness data, which can help extend the product’s life or support new products [6].
PLM Success Results
When PLM is done well, it can help a drug stay in the market longer, increase overall revenue, and allow companies to invest more in developing new medicines [1,4,8].
FACTORS AFFECTING PRODUCT LIFE CYCLE MANAGEMENT
Many internal and external factors affect how well Product Lifecycle Management (PLM) works. These factors influence how strategies are carried out, how much revenue is generated, and how long a product stays successful in the market [1, 9].These factors can create both chances for growth and challenges, so pharmaceutical companies need to plan ahead and handle them carefully [4].
Regulatory and Legal Factors: Strict rules from authorities like the FDA and EMA, along with long approval times and post-launch requirements (such as REMS programs), can slow down product launches or limit how a drug can be used. Legal issues like patent disputes and efforts to extend patents affect how long a company can keep exclusive rights to a drug[3,5]. Also, changes in reimbursement policies or special benefits for rare diseases can impact how successful Product Lifecycle Management (PLM) will be [9].
Competitive Landscape: Competition in the market can affect how well a product performs. When generic or biosimilar versions enter the market, or when similar products and new innovations (like gene therapies) appear, they can reduce a product’s market share. This may force companies to extend the product’s life quickly or lower its price to stay competitive [2,7]. Being the first to launch a drug for a new use can give a short-term advantage and help the product stay successful for a while [ 4].
Economic and Market Dynamics: Factors like pressure from insurance companies (for example, not including a drug in their coverage list), changes in pricing laws such as the Inflation Reduction Act, changes in currency values in global markets, and economic slowdowns can reduce profits and limit investment in Product Lifecycle Management (PLM) [8,10]. Also, since developing a drug is very expensive (around $2.6 billion), companies need to make sure they earn good returns over the product’s life [1].
Technological Advancements: New technologies like AI-based drug discovery, real-world data platforms, and digital therapies can help companies find new uses for drugs faster. However, they also require new patent strategies and efforts to make healthcare professionals adopt them [4,9]. At the same time, problems in the supply chain (like shortages of raw materials or APIs) can disrupt production and delay the product’s success in the market [6].
Internal Organizational Factors: Poor coordination between teams like R&D, marketing, and regulatory can delay early planning for Product Lifecycle Management (PLM). Also, how well resources are managed and how strong the network of key experts (KOLs) is can affect how quickly plans are executed [ 2,5].Strong leadership that focuses on long-term product success, instead of just short-term results, is very important[1].
CHALLENGES OF MANAGEING AGING PRODUCTS IN PLM
As pharmaceutical products get older, their sales can drop very sharply (around 70–90%) after the patent expires. This situation is often called a “patent cliff ” [1,2].
Main Challenges are:-
Overall Impact:
If aging products are not managed properly, many drugs fail to achieve strong sales (for example, not even reaching $250 million at their peak) [1].
STRATEGIES FOR MANAGING AGING PRODUCTS
When a drug’s patent ends, its sales can drop a lot (around 70–90%) because cheaper generic versions enter the market. To reduce these losses and keep the product useful for longer, companies use different simple strategies[1,2].
Launch Own Generic First
When a drug’s patent expires, generic companies can get about 180 days of exclusive selling time. To benefit from this, pharma companies often launch their own generic version during this period. This helps them capture a large share (around 30–70%) of generic sales instead of losing it to competitors. For example, Pfizer did this with Lipitor and earned about $2 billion extra. This strategy works because doctors and pharmacies still trust the original brand, even when it is sold as a generic[1].
New Product Version
Companies make small changes to the medicine—like turning a tablet into an injection, changing it from fast-acting to slow-release, or adding safety features (for example, abuse protection in painkillers). Then they apply through a special pathway like 505(b)(2) with the FDA to get about 3–5 more years of protection. Since it’s not a completely new drug, approval is faster. For example, Nexium was later introduced as Nexium 24HR and stayed in the market for 5+ extra years [1].
New Patient Groups
Companies can extend a drug’s life by getting approval from the FDA to use it for new groups of patients, such as children, elderly people, or those with rare diseases. Paediatric approval can add about 6 extra months of exclusivity, while drugs for rare diseases can get up to 7 years of special protection (orphan drug status). Even though the number of patients may be smaller, profits can be higher because there is little or no generic competition. For example, Viagra received a paediatric extension before its patent expired [3].
Discount Deals with Insurance
After a patent expires, insurance companies and PBMs often remove branded drugs from their “preferred lists” and replace them with cheaper generics. To stay on these lists, pharma companies offer large discounts or rebates (around 30–60%). This helps them keep about 20– 30% of patients using the original brand. This strategy is important because most prescriptions (around 90%) follow the insurance company’s preferred list [2].
Help Patients Pay Less
When patients have to pay on their own, they usually choose the cheapest generic option. To keep them using the branded drug, pharma companies offer support like EMI , free trials for the first month, and mobile apps for easy refills. This helps keep patients loyal even if the generic costs around ?50 and the branded drug costs ?500. This strategy works especially well for longterm (chronic) diseases like diabetes and high cholesterol [2].
Sell in Different Countries
Drug patents expire at different times in different countries. They usually expire first in highprice markets like the US and Europe, and later in countries like India and China (after 2–4 years). Companies use this gap to keep selling the drug in other markets and shift their production and sales focus to earn more revenue. For example, many drugs continue to make good money in Asia even after losing patents in the US [1].
Doctor Switch Program
Doctors may hesitate to switch patients to generics, especially if they trust the original drug. Pharma companies run programs like meetings, seminars, and free samples to show that their newer or upcoming drugs work as well or better. This helps smoothly shift prescriptions from the old drug to a new one and maintain strong relationships with doctors [2].
Sell Old Product
When no other strategy works, companies may sell or license the old drug to a generic manufacturer. They get a one-time payment (around 10–25% of the drug’s peak yearly sales), and the new company takes over production and marketing. This allows the original company to focus on developing new drugs[1].
CASE STUDIES OF PLM
Real-life examples show how good Product Lifecycle Management (PLM) strategies can help old products keep earning money and stay successful for a longer time [1,2].
Case Study 1: Ranbaxy – Simvastatin (Generic of Lipitor)
Challenge:
When Pfizer’s Lipitor patent expired in 2011, Ranbaxy had to decide the right time to launch its generic version in India.
PLM Strategy:
Ranbaxy planned early by filing for approval in advance (ANDA). It also developed a combination of atorvastatin and simvastatin and launched the product early in the Indian market before exporting to the US[1].
Results:
Within 18 months, Ranbaxy captured about 35% of the statin market in India. By the third year, it earned around ?800 crore in revenue. It also used the opportunity after Lipitor’s patent expiry to supply generics to about 40 countries worldwide [1].
Case Study 2: Dr. Reddy's Laboratories – Omeprazole (Generic of Prilosec / Nexium)
Challenge:
AstraZeneca had many additional (secondary) patents on its PPI drugs, making it difficult for generics to enter the market.
PLM Strategy:
Dr. Reddy’s improved the manufacturing process to reduce impurities (from 0.5% to 0.1%). It also offered the drug in different forms like capsules, tablets, and injections, and expanded sales to regulated markets such as the US and Europe[3].
Results:
The company earned about $250 million in the US in the first year after launch. In India, it built a strong PPI business worth around ?1,500 crore. This showed that improving manufacturing processes can successfully compete with existing patents [3].
Case Study 3: Cipla – Tenofovir (HIV Antiretroviral)
Challenge:
Gilead Sciences held the patent for its HIV drug Viread, and there was a debate in India about compulsory licensing to make the drug more affordable.
PLM Strategy:
Cipla applied for a compulsory license under Section 84 (2012) and started local manufacturing. It sold the drug at about 10% of the original branded price and focused on supplying large government tenders[1].
RESULTS:
The cost of HIV treatment dropped significantly (from around ?36,000 to ?3,600 per year). Cipla captured about 60% of the Indian antiretroviral (ARV) market and expanded exports to around 120 countries, making treatment more affordable worldwide [1].
FUTURE TRENDS
India’s Product Lifecycle Management (PLM) is changing with flexible patent rules (TRIPS), growth of biosimilar, and the rise of digital health technologies [3].
Future Growth (India 2030)
By 2030, India’s pharma exports may reach around $130 billion. PLM strategies—especially through biosimilars and fixed-dose combinations (FDCs)—are expected to contribute about 25% of this revenue growth [3].
CONCLUSION
Product Lifecycle Management (PLM) is very important for keeping pharmaceutical companies profitable in the long term. It helps companies handle patent expiry, which could otherwise be a major problem, by planning ahead and using the right strategies. This review shows how PLM manages a product’s journey—from its discovery to peak sales and then the decline phase—by using different strategies at each stage. These include launching their own generics, extending the product’s life, negotiating with insurance companies, and selling in different countries. Indian pharma companies are especially good at this because of their strong manufacturing skills and smart use of regulatory opportunities. New tools like AI-based predictions and real-world data help companies quickly find new uses for drugs and expand their labels. At the same time, companies are using flexible strategies for biosimilars and gene therapies to stay competitive. For Indian pharma companies, focusing on fixed-dose combinations (FDCs), government tenders, and making biosimilars stand out will help them maintain their global position. In the end, good Product Lifecycle Management (PLM) not only helps products stay successful for a longer time but also improves patient access to medicines and makes healthcare more affordable, balancing business goals with public health needs. Strong Product Lifecycle Management (PLM) is what sets top pharma companies apart from others. It helps turn challenges during a product’s life into opportunities, giving companies a competitive edge and supporting future innovation.
CONFLICT OF INTEREST
The authors have no conflicts of interest.
REFERENCES
Anshika Singh*, Aditi Mishra, Sonali Vimal, Sakshi Sharma, Ashvani Kumar, Product Life Cycle Management and Strategies for Aging Products in Pharmaceutical Marketing, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 5, 2093-2101. https://doi.org/10.5281/zenodo.20098340
10.5281/zenodo.20098340