As blockbuster drugs face patent expiries, pharmaceutical companies are adopting a range of strategies to navigate the resulting challenges. Patent expiries lead to the introduction of generic and biosimilar competitors, and in response, both originator companies and generics manufacturers are adjusting their approaches to minimize financial losses and capture new market opportunities.
Branded drug manufacturers focus on innovation, patent extensions, and diversification to protect their market share, while generic and biosimilar companies position themselves to capitalize on the expiration of exclusivity by developing lower-cost alternatives. This dynamic results in increased competition and pharmaceutical companies are taking proactive measures to manage upcoming patent expiries.
Patent Expiry and Strategies deployed by Branded Generic Drug Manufacturers
Here are some key strategies the generic pharma companies employ:
Launch of Generics and Biosimilars: Many companies, including giants like Pfizer, Novartis, and Amgen, are expanding their generics and biosimilars divisions by developing their own lower-cost versions of biologics and small-molecule drugs.
Focus on Specialty and Orphan Drugs: With the traditional blockbuster model becoming riskier, pharmaceutical companies are increasingly focusing on specialty drugs (e.g., cancer treatments, autoimmune diseases) and orphan drugs (for rare diseases). These drugs often come with market exclusivity beyond the standard patent period and face less competition.
Accelerated Mergers & Acquisitions (M&A): Acquisitions of smaller biotech firms with innovative therapies are a frequent response. For instance, Bristol-Myers Squibb's acquisition of Celgene and Gilead's acquisition of Kite Pharma have been motivated by the desire to bolster pipelines as patents expire.
Patent Extensions and Litigation: Companies often seek patent extensions through secondary patents, covering new formulations, delivery methods, or specific patient populations. Additionally, patent litigation against generic manufacturers can delay generic entry.
Product Diversification and Pipeline Development: AbbVie has invested heavily in its pipeline to compensate for the expected revenue loss from Humira’s patent expiration. Similarly, Pfizer focuses on high-growth areas like oncology, rare diseases, and gene therapies to counterbalance the impact of patent cliffs.
Geographic Expansion: Expanding into emerging markets where intellectual property laws and product lifecycles differ can mitigate the loss of exclusivity.
Reinvestment in Research and Development (R&D): Companies aim to bring novel drugs to market. For example, Novartis and Roche have emphasized investment in cutting-edge fields such as gene therapy, digital health, and advanced biologics to replenish their portfolios.
Digital Health Integration and Drug Delivery Innovation: To extend product lifecycles, many companies are investing in digital health tools (e.g., companion diagnostics, patient monitoring systems) and innovative drug delivery systems, which can offer additional therapeutic benefits or improve patient adherence.
Pharmaceutical Patents Expiry: Generic Drug Development
Several pharmaceutical companies are actively developing and preparing to launch generic versions of branded drugs nearing their patent expirations. These companies aim to launch generics immediately after market exclusivity ends, offering more affordable alternatives. Here are some key players in the generic drug industry that target drugs with upcoming patent expiries:
Teva Pharmaceuticals: Teva has a broad pipeline of generics targeting blockbuster drugs nearing patent expiration, with notable targets including Bristol-Myers Squibb's Eliquis (apixaban) and Merck's Januvia (sitagliptin).
Mylan (now part of Viatris): Viatris has an extensive pipeline of generic drugs targeting those whose patents are expiring, particularly in areas like oncology, cardiovascular, and central nervous system diseases. Notable targets include Crestor (rosuvastatin) and Advair (fluticasone/salmeterol).
Sandoz (a division of Novartis): Sandoz is actively working on launching generic versions of several high-revenue drugs with upcoming patent expiries, their target drugs include Humira (adalimumab), Lantus (insulin glargine), and Imbruvica (ibrutinib).
Hikma Pharmaceuticals: Hikma has been preparing for the launch of generic versions of several top-selling drugs, especially in respiratory and pain management segments. Notable targets include Advair and OxyContin.
Amneal Pharmaceuticals: Amneal is focused on developing generics across a wide range of therapeutic areas, including oncology, neurology, and infectious diseases. Amneal is focusing on complex generics (e.g., inhalers, injectables) and biosimilars such as Revlimid (lenalidomide) and Sensipar (cinacalcet).
Lupin Pharmaceuticals: Lupin's pipeline includes generics for drugs in oncology, cardiovascular, and diabetes care. Notable targets include Spiriva (tiotropium bromide) and Januvia (sitagliptin).
Sun Pharmaceutical Industries: Sun Pharma has been aggressively developing generic versions of leading drugs with upcoming patent expiries, especially in the dermatology and oncology segments. Notable targets include Abraxane (paclitaxel) and Gleevec (imatinib).
Cipla: Cipla is known for its strong focus on respiratory generics and affordable medicines. The company is expanding its generics portfolio to target high-value drugs that are losing patent protection, particularly in inhalation therapy, oncology, and HIV treatment.
Notable targets include Advair and Symbicort (budesonide/formoterol).
Dr. Reddy's Laboratories: Dr. Reddy's has been targeting high-revenue drugs across oncology, gastroenterology, and neurology. Their target drugs include Revlimid and Tecfidera (dimethyl fumarate).
Zydus Cadila: Zydus Cadila is actively working on generic versions of several blockbuster drugs, particularly in the diabetes and cardiology areas. There are working on generic drugs such as Lantus and Humira.
Fresenius Kabi: Fresenius focuses on generic injectable products, particularly in the oncology and critical care markets. It has been developing generic and biosimilar versions of complex drugs with patents expiring soon. Notable targets include Neulasta (pegfilgrastim) and Remicade (infliximab).
The upcoming wave of patent expiries will lead to greater competition, increased access to affordable treatments, and price reductions for patients and healthcare systems. These companies are well-positioned to take advantage of patent expiries by launching affordable generics, particularly in high-revenue therapeutic areas like oncology, diabetes, cardiovascular diseases, and biologics/biosimilars. As a result, the generics and biosimilars market will continue to grow rapidly, reshaping the pharmaceutical landscape and driving innovation in drug formulations and delivery systems.
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