Last month, we released our third annual ANDA Litigation Intelligence Report evaluating all stakeholders in ANDA/Hatch-Waxman cases filed over the last five years, from July 1, 2017, through June 30, 2022. Previously, on Patexia 148, we analyzed the filing trends during the period of our study, while this week’s insight will be focused on the top brand and generic pharmaceutical companies based on their performance.
During the five-year period considered in our study, a total of 1,439 unique ANDA cases were filed, including 1,531 unique patents. However, the filing activity fluctuated from 349 cases/year in 2018 to 239 cases in 2021. Therefore, to adjust for partial years and better understand the latest data from 2022, we analyzed the monthly activity summarized in the chart below:
The average number of ANDA cases filed per month was: 26.3, 29.1, 24.9, 22.1, 19.9, and 21.5 from 2017 to 2022, respectively, which reflects a decline that started in 2018, which was also the year with the highest case filings. However, the data from the first half of 2022 indicates a slight increase in the monthly filings. As we analyzed in the Patexia 151, together with the drugs expected to expire during 2022-2023, this might indicate increased ANDA activity in the near future.
In the 1,439 ANDA cases filed from July 1, 2017, through June 30, 2022, 415 pharmaceutical companies participated, out of which 240 companies were named plaintiffs, while 226 were named defendants. Our data shows that, on average, brand and generic companies participated in 8.7 and 8.6 cases, respectively. The average number of cases does not show much about a handful of companies that participated in more than 50 cases and became some of the most active during the period of our study. For this reason, we developed our Activity Score based on the number of cases in which an entity was involved. Behind the filings of all of these cases, there is always a business justification, as companies do not simply file a case without a strategy to recover the huge litigation costs. By allocating points according to the ANDA case outcomes for all participating entities, we developed the Success Scores, which were used further for our Performance Scores. We calculate the performance score as a weighted average of both activity and success. The following table shows the five best-performing generic pharma companies, earning their mention for their high activity and success in ANDA cases:
|Generic Performance Rank||Company||Caseload||Generic Performance Score|
- Glenmark Pharmaceuticals was the best-performing generic pharmaceutical company. Founded in 1977, it entered the market initially with a focus on dermatology products. The expansion towards the US market came during 2005 with some out-licensing deals throughout the years and ultimately with generic products, highlighting ezetimibe, the first and only generic version of Zetia used to treat high cholesterol. They have worked closely with Hill Wallack LLP, Rakoczy Molino Mazzochi Siwik, and Knobbe Martens Olson & Bear, LLP, for their ANDA litigation practice. During the past five years, they have been involved in several battles with some of the most active pharmaceutical brands, including Novartis, Viatris, and Pfizer. In a notorious case against Viatris, they managed to get FDA approval for the generic version of Evoclin® Foam, marketed by them as Clindamycin Phosphate, an antibiotic used to treat acne. According to IQVIA sales data for the 12-month period ending July 2021, Evoclin achieved annual sales of approximately $12.0 million.
- Sun Pharma, founded in 1983, has grown into one of the largest generic pharmaceutical companies. Its portfolio of over 2000 small molecule drugs has brought them revenues of over $4.3 billion in 2021 globally. Carlson Caspers Vandenburgh & Lindquist, Katten Muchin Rosenman, and Goodwin Procter LLP were their three main law firms securing high success rates in ANDA litigation. As we covered in our previous report, some of the key ANDA attorneys at Goodwin moved to Allen & Overy earlier this year.
- Dr. Reddy's Laboratories, established in 1985 and aimed to bring affordable medicines to the market, got its first FDA approval in 1987 for API ibuprofen. They have recently secured FDA approval for a generic version of Bristol-Myers Squibb’s Revlimid, used to treat various types of cancers. This important move is expected to increase their revenue further and rank them even beyond the 9th place they already occupy in a list by FiercePharma related to their global generics sales. They rely on Perkins Coie, Windels Marx Lane & Mittendorf, and Lerner David Littenberg Krumholz & Mentlik for their ANDA litigation practice.
- Bionpharma Inc. was founded in 2014, acquiring 25 products from specialty drug maker Banner Life Sciences. With this jump start, they have become an important player in the generics market, with eight product approvals obtained from FDA and four more ANDAs filed with FDA in 2019 alone. Taft Stettinius & Hollister, Sterne, Kessler, Goldstein & Fox, and Fox Rothschild were the main law firms they worked closely with for the Hatch-Waxman matters.
- Alkem Laboratories Ltd. founded in 1973, began its activity in the US with its first ANDA filing for the drug Amlodipine in 2007 and receiving FDA approval in 2009. Since then, they have expanded their generics portfolio which ultimately brought them a revenue of $1 billion in 2019, of which $200 million came from the US market. They have closely worked with Rakoczy Molino Mazzochi Siwik, Windels Marx Lane & Mittendorf, and Taft Stettinius & Hollister for ANDA litigation.
On the other hand, the following are the top five best-performing brand pharmaceutical companies based on our latest report:
|Brand Performance Rank||Company||Caseload||Brand Performance Score|
- Vanda Pharmaceuticals was founded in 2003 and is dedicated to using new technologies, including genetics and genomics, to lead in new drug discoveries. Vanda’s portfolio comprises mainly two products, Hetlioz for nighttime sleep disturbances and Fanapt for the treatment of schizophrenia. In the recent three years, they have generated revenue of over $200 million. Paul Weiss, Rifkind Wharton & Garrison, and Durie Tangri were their main law firms used for ANDA litigation.
- Teva Pharmaceuticals has always been one of the top generic drug makers when it comes to revenue. Nonetheless, in a major move in 2016, they were accepted in the Pharmaceutical Research and Manufacturers of America, known for their reputation as a strong defender of brand-name companies. The fierce rivalry between generic and brand companies seems to be a thing of the past decades, while now the lines are becoming blurred. Teva, for instance, has also marketed brand-name medicines such as the Copaxone multiple sclerosis treatment. They have worked closely with Goodwin Procter LLP, Sterne, Kessler, Goldstein & Fox, and Williams & Connolly for ANDA litigation.
- Lundbeck ranks third best performing brand company. In 2010, they announced a new R&D strategy that enabled them to deliver breakthrough drugs while maintaining the focus on neuroscience research as they have done in the past 70 years. In this way, Lundbeck has built a rich patent portfolio, ranking also in the top 100 companies in patent prosecution in our Patent Prosecution Intelligence Report 2022. For ANDA litigation, they rely on Finnegan, Henderson, Farabow, Garrett & Dunner.
- Takeda Pharmaceutical Company Limited is the largest pharmaceutical company in Asia and the 11th globally by revenue. Entyvio, Velcade, and Leuprorelin are their best-selling drugs. Their R&D focuses on four core therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology. Patterson Belknap Webb & Tyler, Munger Tolles & Olson, and Womble Bond Dickinson were their three main law firms regarding ANDA litigation.
- Eagle Pharmaceuticals, Inc. was founded in 2007 with R&D focusing on oncology, critical care, and orphan diseases. Since 2016 they have been generating over $100 million in revenue, while this year, they completed the acquisition of Acacia Pharma Group. With this move, they also gained rights to two New Chemical Entities, NCW, Barhemsys, and Byfavo, both currently available in the market. They have worked closely with Latham & Watkins, Kirkland & Ellis, and Williams & Connolly for ANDA litigation.
The full ANDA Litigation Intelligence Report goes further, covering several ANDA statistics as well as providing complete rankings for 415 pharma companies in the extended Excel document that comes with the report. The report also includes attorneys, law firms, and judges. Stay tuned, as in the following weeks we will be covering more statistics from the ANDA Litigation Intelligence Report, revealing some of the best performing and most active attorneys and law firms.