Patexia Insight 218: A Deep Dive into the Top Pharmaceutical Companies in ANDA Litigation
In the pharmaceutical industry, innovation drives progress, but intense legal battles, particularly in ANDA (Abbreviated New Drug Application) litigation, shape the competitive landscape. Our recently released 2024 ANDA Litigation Intelligence Report provides an in-depth analysis of the key players in this sector, shedding light on the top pharmaceutical companies driving this litigation as both brand plaintiffs and generic defendants.
Brand companies (plaintiffs) seek to maintain their market exclusivity by initiating legal actions against competitors who aim to introduce generic alternatives. In contrast, generic companies (defendants) focus on entering the market with more affordable options. The outcomes of these cases can significantly influence market competition and consumer access to affordable medications.
Brand Plaintiffs: Protecting Market Share
From July 1, 2019, to June 30, 2024, Johnson & Johnson and Bristol Myers Squibb have been active plaintiffs among brand pharmaceutical companies, focusing on protecting their intellectual property. Johnson & Johnson was involved in 109 ANDA cases, securing a performance score of 100%, while Bristol Myers Squibb reached a performance score of 97.98%. These figures reflect their efforts to maintain patent rights and market exclusivity.
| Plaintiff Rank | |||||
|---|---|---|---|---|---|
| Brand Company | Rank | Category | Plaintiff Cases | Plaintiff Performance Score | Top 3 Firms |
| Johnson & Johnson | 1 |
Performance and Activity |
109 | 100.00% | Patterson Belknap Webb & Tyler (13); Paul Hastings (10); Kramer Levin Naftalis & Frankel (9) |
| Bristol Myers Squibb | 2 | Performance | 59 | 97.98% | Quinn Emanuel Urquhart & Sullivan (24); Jones Day (24); Kirkland & Ellis (7) |
| Pfizer | 2 | Activity | 90 | 86.05% | Williams & Connolly (30); White & Case (10); Wilmer Cutler Pickering Hale and Dorr (1) |
| Takeda Pharmaceutical Company Limited | 3 | Performance | 23 | 92.85% | Patterson Belknap Webb & Tyler (8); Haug Partners (5); Faegre Drinker Biddle & Reath (4) |
| Merck & Co., Inc. | 3 | Activity | 84 | 86.55% | Jones Day (19); Williams & Connolly (19); Latham & Watkins (3) |
| Vanda Pharmaceuticals | 4 | Performance | 15 | 89.32% | Paul Weiss Rifkind Wharton & Garrison (12); Groombridge, Wu, Baughman & Stone LLP (6); McDermott Will & Emery (3) |
| AbbVie Inc. | 4 | Activity | 56 | 75.66% | Finnegan, Henderson, Farabow, Garrett & Dunner (8); Covington & Burling LLP (6); Quinn Emanuel Urquhart & Sullivan (4) |
| Acadia Pharmaceuticals | 5 | Performance | 8 | 88.00% | Paul Hastings (8) |
| AstraZeneca | 5 | Activity | 51 | 84.42% | Finnegan, Henderson, Farabow, Garrett & Dunner (12); O'Melveny & Myers LLP (11); Williams & Connolly (11) |
Chart 1.1: Trends in ANDA Case Filings (2019-2024). Source: 2024 ANDA Litigation Intelligence Report.
Generic Defendants: Challenging Brand Exclusivity
In the highly competitive generic drug market, companies like Aurobindo Pharma and Sun Pharmaceutical Industries actively seek to enter markets faster by leveraging Paragraph IV certifications. This process allows generic manufacturers to challenge the validity of brand-name pharmaceutical patents, asserting that their generic versions either do not infringe on the existing patents or that the patents themselves are invalid. When these challenges are made, they commonly trigger lawsuits from brand-name companies aiming to protect their market exclusivity.
Aurobindo Pharma and Sun Pharmaceutical Industries have been proactive in their efforts to bring lower-cost alternatives to market through Paragraph IV challenges, which often lead to legal disputes with brand-name companies. Aurobindo Pharma, having faced 107 cases as a result of these efforts, achieved a performance score of 86.63%. Sun Pharmaceutical, participating in 79 cases, earned a higher performance score of 99.32%, highlighting their effectiveness in navigating these legal battles and pushing for earlier market entry (see Chart 1.2).
| Defendant Rank | |||||
|---|---|---|---|---|---|
| Generic Company | Rank | Category | Defendant Cases | Defendant Performance Score | Top 3 Firms |
| Sun Pharmaceutical Industries Ltd. | 1 | Performance | 79 | 99.32% | Katten Muchin Rosenman (9); Carlson Caspers Vandenburgh & Lindquist, PA. (9); Vorys Sater Seymour & Pease (6) |
| Aurobindo Pharma | 1 | Activity | 107 | 86.63% | Withersworldwide (21); Pergament & Cepeda LLP (8); McNeely, Hare, & War (6) |
| Hetero | 2 | Performance | 62 | 87.46% | Pergament & Cepeda LLP (13); Wiley Rein LLP (5); Carlson Caspers Vandenburgh & Lindquist, PA. (3) |
| Lupin Limited | 2 | Activity | 105 | 87.18% | Knobbe Martens (22); Locke Lord (13); Rakoczy Molino Mazzochi Siwik (13) |
| Teva Pharmaceuticals | 3 | Activity | 94 | 79.19% | Sterne, Kessler, Goldstein & Fox (15); Williams & Connolly (13); Kirkland & Ellis (7) |
| MSN Laboratories | 4 | Activity | 91 | 81.31% | ArentFox Schiff (11); Daignault Iyer LLP (10); Windels Marx Lane & Mittendorf, LLP (7) |
| Zydus Lifesciences Limited | 5 |
Performance and Activity |
91 | 86.49% | Locke Lord (48); Weil, Gotshal & Manges (3); Axinn Veltrop & Harkrider (1) |
Chart 1.2: Trends in ANDA Case Filings (2019-2024). Source: 2024 ANDA Litigation Intelligence Report.
Teva Pharmaceutical also stands out as a significant player, excelling in both plaintiff and defendant roles. With a perfect overall activity score of 100%, which reflects the number and recency of their cases, Teva has participated in 115 cases—94 as a defendant and 21 as a plaintiff (see Chart 1.3).
| Overall Ranking | ||||
|---|---|---|---|---|
| Company | Overall Rank | Category | All Cases | Overall Activity Score |
| Teva Pharmaceuticals | 1 | Activity | 115 | 100.00% |
| Bristol Myers Squibb | 1 | Performance | 59 | 94.50% |
| Johnson & Johnson | 2 |
Performance and Activity |
110 | 99.83% |
| Novartis | 3 | Activity | 119 | 99.80% |
| Hetero | 3 | Performance | 62 | 95.64% |
| Aurobindo Pharma | 4 | Activity | 108 | 99.10% |
| Takeda Pharmaceutical Company Limited | 4 | Performance | 23 | 87.28% |
| Lupin Limited | 5 | Activity | 105 | 98.99% |
| Merck & Co., Inc. | 5 | Performance | 84 | 96.98% |
Chart 1.3: Trends in ANDA Case Filings (2019-2024). Source: 2024 ANDA Litigation Intelligence Report.
Case Studies: Strategies and Outcomes
Johnson & Johnson and Bristol Myers Squibb (BMS) have consistently employed aggressive legal strategies to safeguard market exclusivity. For example, in a significant ANDA case, Actelion Pharmaceuticals Ltd. (acquired by Johnson & Johnson in 2017) engaged in a patent infringement dispute with Viatris Inc. (formerly Mylan Pharmaceuticals Inc.) over two key patents related to the drug VELETRI® (epoprostenol sodium for injection). Actelion not only sought to block the approval of Viatris ANDA but also requested a permanent injunction to prevent Viatris from producing or selling the generic drug until the patents expired—a request that was ultimately granted by the court.
J&J affirms that the protection offered by their robust patent systems enables them to disclose information about their inventions, aiming to accelerate the development of competing technologies.
Bristol Myers Squibb has also been active in defending its patents against generic challengers. A notable recent case is the litigation against Zydus Pharmaceuticals (USA) Inc., where BMS defended patents related to its blood thinner Eliquis (apixaban). The outcome of this case resulted in a settlement, requiring Zydus to delay the launch of its generic version of Eliquis until after the agreed-upon period, thus allowing BMS to extend its market exclusivity for a few additional months.
Aurobindo Pharma successfully challenged the validity of Astellas Pharma Inc.'s patents for the drug Xtandi. Despite Astellas' efforts to block Aurobindo from bringing a cheaper generic version to market, the court ruled in favor of Aurobindo, allowing them to proceed with their generic product. Meanwhile, Teva Pharmaceuticals is engaged in ongoing litigation with Neurocrine Biosciences Inc. over the patent for Ingrezza, illustrating the complexity of defending market exclusivity against generic competition.
These cases highlight how both brand and generic companies employ multifaceted strategies to navigate ANDA litigation, protect intellectual property, and secure market share. Teva Pharmaceuticals and Aurobindo Pharma, in particular, have been involved in significant ANDA litigations that illustrate their legal tactics and the broader impact on the pharmaceutical industry.
Ranking Methodology
Understanding the top players in ANDA litigation is essential for brand and generic manufacturers, as well as the firms and attorneys representing them. For brand companies, this knowledge allows them to anticipate potential generic challengers and develop preemptive legal strategies. Generic manufacturers can assess the risks and opportunities involved in patent challenges, gaining insights into who they are up against. Similarly, firms and attorneys specializing in ANDA litigation can leverage these rankings to identify key players, assess competition, and refine their legal strategies.
The report analyzed 1,321 ANDA cases –involving 442 companies, 1,480 attorneys, and 199 law firms–over this five-year period, meticulously calculating activity and success scores based on factors such as case involvement, patent validity challenges, and litigation outcomes. As a result, these scores provide a data-driven ranking that reflects the impact and effectiveness of each company involved.
Our proprietary ranking methodology evaluates the activity, success, and performance of companies, law firms, and attorneys within ANDA litigation. By analyzing metrics such as case involvement, success rates, and the strategic impact of each player, we generate a final score that forms the basis of our rankings. This approach ensures that our rankings reflect not only case volume but also the companies' effectiveness. For a deeper analysis and to explore the full rankings, get your copy of the 2024 ANDA Litigation Intelligence Report today.