Patexia Insight 192: Top Brand and Generic Companies in ANDA 2023
In August, our much-anticipated fourth annual ANDA Litigation Intelligence Report made its entrance into the world of pharmaceutical litigation. This report series shines a spotlight on the intricate web of ANDA (Abbreviated New Drug Application) cases and delves deep into the statistical landscape, offering a comprehensive overview of the evolving trends in the pharmaceutical industry's legal arena. Furthermore, this report diligently assesses all the stakeholders engaged in these cases, including companies, law firms, and attorneys, analyzing various signals and ranking them based on their activity and performance in brand, generic, and overall categories.
ANDA litigation is a crucial battleground in the pharmaceutical industry, where generic and brand drug companies compete for market share and regulatory approval, often involving substantial financial stakes. For all industry stakeholders, grasping the key players and their performance is essential in this highly competitive environment. Today's insight will be dedicated to unveiling the top-performing brand and generic companies and shedding light on their practices.
In the fourth edition of the Patexia ANDA Litigation Intelligence Report, we evaluated and ranked stakeholders involved in ANDA cases, using data spanning a five-year filing period from July 1, 2018, to June 30, 2023. The statistics gathered over this half-decade offer valuable insights into recent ANDA litigation trends, highlighting significant fluctuations in the number of cases filed. As seen above, during our study period, a total of 1,428 ANDA cases were submitted, with the highest yearly total of 318 cases occurring in 2019. Subsequently, there was a decrease in ANDA activity during 2020 and 2021, but in 2022, we observed a resurgence with 263 new cases filed. During the first half of 2023, there was an increase in legal activity, with 149 cases filed, as opposed to 135 cases recorded during the corresponding period in 2022. This surge in cases indicates a noticeable uptick in ANDA litigation, underscoring the ever-evolving dynamics within the pharmaceutical industry concerning challenges and approvals for generic drugs. This rising trend was previously discussed in Patexia 185.
In our quest to provide a comprehensive perspective on ANDA litigation, we examined thoroughly the activities of all 469 companies identified as defendants or plaintiffs throughout this extensive study. But the question remained: how do we measure success in the realm of ANDA litigation, where a company with a single case won can rank above a company with 9 out of 10 cases won? To address this challenge, we devised a robust Performance Score that takes into account both the activity and success scores of defendants and plaintiffs through a weighted average approach. This year, we've taken a further rigorous approach to ensure the fairness and accuracy of our Success Score evaluation. To eliminate external factors' influence, like the success of other entities or the actions of judges, we've implemented a strong analytical model based on advanced machine learning techniques. This model enables us to isolate the performance of each entity, whether it's a company, attorney, or law firm, from any potential effects caused by other parties involved in ANDA cases. In this way, we offer a more precise and unbiased assessment of individual success in the litigation landscape.
The table below highlights the top five generic pharmaceutical companies, recognized for their top performance in ANDA cases, attributed to their significant activity and successful outcomes:
| Generic Performance Rank | Company | Cases | Performance Score |
|---|---|---|---|
| 1 |
113 |
100.00% |
|
| 2 | Sun Pharmaceutical Industries Ltd. | 69 | 99.61% |
| 3 |
107 |
96.67% |
|
| 4 | Zydus Lifesciences Limited | 101 | 96.47% |
| 5 |
106 |
95.49% |
- Teva Pharmaceuticals, the best-performing generic in 2023, is an Israeli multinational pharmaceutical headquartered in Tel Aviv, Israel. This industry leader is renowned for its specialization in generic drugs, catering to the healthcare needs of patients worldwide. Teva is also venturing into the emerging biosimilar market, exemplified by a recent expansion of its partnership with Alvotech, a move that underscores the company's commitment to innovation and growth. Teva Pharmaceuticals' Q2 2023 financial report revealed revenues reaching $3.9 billion, a figure that represents a notable 4% increase compared to the revenues generated in the previous year's Q2. Sterne, Kessler, Goldstein & Fox, Kirkland & Ellis, and Williams & Connolly were the top law firms that provided the legal expertise essential for Teva's continued triumph in this fiercely competitive field.
- Sun Pharmaceutical Industries Ltd. (Sun Pharma), securing the second position as the best-performing generic company in 2023, stands as the fourth largest specialty generic pharmaceutical firm globally, boasting global revenues exceeding US$ 5.1 billion. The company's robust performance is underscored even by its recent second-quarter profit report, which exceeded their expectations. Sun Pharma reported a net profit after tax of 23.76 billion rupees ($285.37 million) for the quarter ending on September 30, marking a rise from 22.62 billion rupees in the previous year. This surge in profitability is attributed to strong sales in both their domestic and U.S. formulation businesses. In the realm of ANDA litigation, Sun Pharma partnered with law firms such as Katten Muchin Rosenman, Carlson Caspers Vandenburgh & Lindquist, PA, and Kratz & Barry, which play a pivotal role in Sun Pharma's legal strategy, ensuring their continued success in this competitive arena.
- Lupin Limited, securing the third spot as the best-performing generic company in 2023, has a rich history dating back to its establishment in 1968 by Dr. Desh Bandhu Gupta. Lupin has emerged as a global healthcare leader, making a significant mark in the pharmaceutical industry, and also entering the highly competitive U.S. market in 2003. Lupin's financial performance in the April-June quarter reports a net profit of Rs 453.33 crore ($54,46 million), marking a turnaround from the consolidated net loss of Rs 86.8 crore reported during the same period in the previous year. The top three law firms representing Lupin Limited in ANDA litigation were Knobbe Martens, Locke Lord, and Rakoczy Molino Mazzochi Siwik.
- Zydus Lifesciences Limited ranking fourth best-performing generic company in 2023, is previously known as Cadila Healthcare Ltd. and a part of the Zydus Group. The company then transformed, unifying itself under the Zydus name. In terms of financial performance, the company reported a net profit of 10.87 billion rupees ($131.3 million) in the quarter ending on June 30, marking a substantial increase from the 5.18 billion rupees recorded in the previous year. Notably, their U.S. formulations business witnessed revenue growth of 57.4%, reaching 24.54 billion rupees, underscoring their success and relevance in the U.S. pharmaceutical market. Their top three law firms were Locke Lord, Maschoff Brennan, and Axinn Veltrop & Harkrider, each playing a crucial role in the company's legal strategy and success in the complex landscape of pharmaceutical litigation.
- Aurobindo Pharma, securing the fifth rank as the best-performing generic company in 2023, is distinguished in the pharmaceutical landscape known for its presence in therapeutic segments such as neurosciences, cardiovascular, antiretrovirals, anti-diabetics, gastroenterology, and anti-biotics among others. In the financial arena, the company reported a 22.5% decline in consolidated net profit, recording Rs 540.40 crore ($64.9 million) in the April-June quarter. This figure marked a decrease from the net profit of Rs 697.60 crore in the year-ago period. However, Aurobindo Pharma’s revenue from operations reached Rs 6,850.50 crore, reflecting a 10% increase from the same quarter in the previous fiscal year. Their top legal partners, Kratz & Barry, Withersworldwide, and ArentFox Schiff, play a pivotal role in the company's legal strategy, contributing to its success in navigating the complex landscape of pharmaceutical litigation.
Having explored the performance of the top generic pharmaceutical companies in 2023, it's now time to shift our focus to the key players in the brand-name pharmaceutical sector. The following table reveals the top-performing brand companies, along with their performance scores and ANDA caseloads.
| Brand Performance Rank | Company | Cases | Performance Score |
|---|---|---|---|
| 1 |
16 |
100.00% |
|
| 2 | Bristol Myers Squibb | 77 | 96.71% |
| 3 |
27 |
96.21% |
|
| 4 | Bayer Corporation | 41 | 94.59% |
| 5 |
87 |
92.89% |
- Endo International leads as the best-performing brand company in 2023, and boasts a diverse specialty portfolio that encompasses products spanning urology, men's health, orthopedics, and endocrinology. The company's commitment to innovation is focused in two key areas: brand pharmaceuticals, and sterile injectable high-value generic medicines. The financial snapshot of Endo International in Q2 2023 reveals a comprehensive view of its revenue streams. The company reported revenues in various segments, with Branded Pharmaceuticals, Sterile Injectables, Generic Pharmaceuticals, and International Pharmaceuticals contributing to the total revenues of $547 million. In the realm of ANDA litigation, Endo International strategically collaborates with Dechert, Axinn Veltrop & Harkrider, and Latham & Watkins among other firms. These legal partners play a pivotal role in shaping the company's legal strategy and ensuring their continued success in safeguarding their intellectual property rights and products in the competitive pharmaceutical landscape.
- Bristol Myers Squibb stands as the second-best performing brand company in 2023 and is known for its dedication to advancing healthcare. In 2022, they made an investment of $9.5 billion in research and development, epitomizing their commitment to discovering and developing new medicines. The therapeutic areas that Bristol Myers Squibb focuses on are diverse and impactful, encompassing oncology, hematology, blood cancer treatments, immunology, cardiovascular disease, and neuroscience, addressing a multitude of medical needs. In the realm of ANDA litigation, Bristol Myers Squibb strategically partners with law firms such as Jones Day, Quinn Emanuel Urquhart & Sullivan, and Covington & Burling LLP, which play a pivotal role in shaping the company's legal strategy and ensuring their continued success in protecting their innovative treatments and intellectual property.
- Neurocrine Biosciences, securing the third position as one of the best-performing brand companies in 2023, is an industry leader with a history of more than 30 years dedicated to researching potential life-changing treatments for patients grappling with neurological, neuroendocrine, and neuropsychiatric disorders. The company's flagship drug, INGREZZA (valbenazine), reported a 29% year-over-year growth in net product sales, reaching $486 million. This success has led to the company's raise of its 2023 net sales guidance for INGREZZA to a range of $1.82 to $1.84 billion, highlighting the drug's role in its growth and prominence in the pharmaceutical market. In the ANDA landscape, Neurocrine has collaborated mainly with Finnegan, Henderson, Farabow, Garrett & Dunner.
- Bayer Corporation, ranked as the fourth best-performing brand company in 2023, is a venerable Life Science company with a history that spans more than 150 years. Leveraging core competencies in healthcare and agriculture, their portfolio of best-selling products includes a range of pharmaceuticals that have made a significant impact in healthcare. From Adalat™ to Xarelto™, Bayer's pharmaceutical offerings have contributed to improving the lives of countless patients. In terms of financial performance, Bayer has reported strong figures, with a current revenue (TTM) of $51.63 billion. In 2022, the company achieved a revenue of $53.67 billion, marking an increase over the previous year's revenue of $51.30 billion. In the realm of ANDA litigation, Bayer Corporation collaborates the most with Williams & Connolly and Carey Douglas Kessler & Ruby PLLC.
- Merck & Co., Inc. the fifth-ranked best-performing brand company in 2023, stands as a prominent American multinational pharmaceutical company with its headquarters in Rahway, New Jersey. The company's history is deeply intertwined with the Merck Group, originally founded in Germany in 1668, of which Merck & Co., Inc. once served as the American arm. Merck & Co., Inc. focuses on several critical areas, including oncology, vaccines, infectious diseases, and cardio-metabolic disorders. In the third quarter of 2023, Merck reported total worldwide sales of $16.0 billion, marking a 7% increase compared to the same period in 2022. In the realm of ANDA litigation, Merck collaborates mostly with Williams & Connolly, Jones Day, and Quinn Emanuel Urquhart & Sullivan.
The full ANDA Litigation Intelligence Report offers a comprehensive analysis of ANDA-related data spanning a 5-year period, from July 1, 2018, to June 30, 2023. This in-depth examination encompasses 1,428 ANDA cases, 1,774 patents, 1,936 attorneys, 226 law firms, 469 pharmaceutical companies, and interactions within the legal landscape involving 153 judges. Moreover, this report includes insights and analysis on the trends that shape the pharmaceutical industry's legal landscape such as the outcome analysis, most frequently encountered IPC codes, top ANDA jurisdictions, and more. In addition, the report spotlights top legal minds within the industry. Attorneys who have earned high ranks in the Patexia rankings are showcased, along with written reviews from their colleagues, in-house counsel, and even opposing attorneys. This unique perspective provides a well-rounded view of the legal professionals who are making significant contributions to the ANDA litigation landscape.
Stay tuned for more updates and revelations from this report that will further enrich our understanding of the pharmaceutical and legal realms. It's a valuable resource for those invested in ANDA litigation and the ever-evolving dynamics of the industry.