Novo Nordisk A/S, trading on the New York Stock Exchange under the ticker NVO, is confronting allegations that it orchestrated a multi-year anticompetitive strategy to unlawfully maintain monopoly control over its diabetes drug Victoza. The accusations come from a class action complaint filed in the U.S. District Court for the Eastern District of New York by JM Smith Corporation, operating as Smith Drug Company. This complaint asserts that Novo Nordisk deliberately implemented measures to delay the introduction of generic alternatives, thereby securing billions of dollars in profits while steering patients toward its newer glucagon-like peptide-1 (GLP-1) receptor agonist product, Ozempic, ahead of generic entry into the market.
Victoza, a liraglutide injection pen produced and marketed by Novo Nordisk, is indicated for improving glycemic control in patients aged ten years and older diagnosed with Type 2 diabetes. Additionally, it serves to reduce cardiovascular risks in selected patient populations. Publicly accessible legal documents reveal that Victoza generated U.S. sales exceeding $5 billion in 2018. According to the lawsuit, this medication's dominant market position was protected beyond the expiration of its last active pharmaceutical ingredient (API) patent in August 2022, due in part to pediatric exclusivity provisions extending the marketing monopoly through February 22, 2023.
Critically, in the absence of the practices now challenged in court, generic formulations of Victoza would have entered the market promptly following patent expiry, dramatically lowering prices as consumers and prescribers shifted toward these more affordable alternatives. Plaintiffs contend that Novo Nordisk carried out a deliberate plan to postpone generic Victoza availability while redirecting prescription volumes toward Ozempic, a second-generation GLP-1 receptor agonist that currently faces no imminent generic competition. Ozempic is primarily approved to manage glycemic control in adults with Type 2 diabetes and to mitigate cardiovascular and renal risks in specific subsets of patients.
The lawsuit highlights several key components of Novo Nordisk’s strategy, including the improper listing of device patents in the Food and Drug Administration’s Orange Book. This action allegedly triggered regulatory delays aligned with provisions under the Hatch-Waxman Act, a federal statute governing generic drug approvals. Moreover, the complaint scrutinizes a 2019 settlement agreement between Novo Nordisk and Teva Pharmaceutical Industries Ltd., noted as the first potential producer of generic Victoza. This deal allegedly included an impermissible reverse payment, which postponed Teva’s generic launch until June 24, 2024, while granting it exclusive sales rights for the initial 180 days after launch.
The plaintiffs further assert that Novo Nordisk actively impeded other generic manufacturers from challenging the contested patents, effectively preventing the U.S. Food and Drug Administration from approving additional competing generics until after Teva’s exclusivity period concluded. Collectively, these alleged actions resulted in at least a 16-month delay in generic Victoza availability. This delay preserved Novo Nordisk’s monopoly pricing power and permitted both Novo and Teva to maintain supracompetitive pricing levels in the market, as stated in the lawsuit.
According to the complaint, this scheme compelled purchasers—including wholesalers, pharmacies, and patients—to pay inflated prices not only for original Victoza and its eventual generics but also for Ozempic. The plaintiffs argue that demand for Ozempic would have been diminished had generic Victoza become accessible in a timely manner, due to the availability of a less expensive alternative fulfilling a similar therapeutic role.
The legal action aims to secure compensation exceeding hundreds of millions of dollars, representing alleged overpayments tied to purchases of Victoza, generic versions thereof, and Ozempic occurring throughout the period affected by the purported delay.
As of the latest available trading data at the time of filing, Novo Nordisk’s stock price was reported at $58.82 per share, reflecting a decrease of approximately 0.87% on that trading day. Concurrently, Teva Pharmaceutical Industries Ltd., linked to the settlement agreement in question, traded at $32.55, down 1.59%.
The dispute underscores significant regulatory, legal, and market dynamics within the pharmaceutical sector, particularly related to patent protections, market exclusivities, and pricing strategies for high-demand specialty drugs. The outcome of this litigation may have notable implications for pricing, accessibility, and competition in the diabetes treatment market segment.
Victoza, a liraglutide injection pen produced and marketed by Novo Nordisk, is indicated for improving glycemic control in patients aged ten years and older diagnosed with Type 2 diabetes. Additionally, it serves to reduce cardiovascular risks in selected patient populations. Publicly accessible legal documents reveal that Victoza generated U.S. sales exceeding $5 billion in 2018. According to the lawsuit, this medication's dominant market position was protected beyond the expiration of its last active pharmaceutical ingredient (API) patent in August 2022, due in part to pediatric exclusivity provisions extending the marketing monopoly through February 22, 2023.
Critically, in the absence of the practices now challenged in court, generic formulations of Victoza would have entered the market promptly following patent expiry, dramatically lowering prices as consumers and prescribers shifted toward these more affordable alternatives. Plaintiffs contend that Novo Nordisk carried out a deliberate plan to postpone generic Victoza availability while redirecting prescription volumes toward Ozempic, a second-generation GLP-1 receptor agonist that currently faces no imminent generic competition. Ozempic is primarily approved to manage glycemic control in adults with Type 2 diabetes and to mitigate cardiovascular and renal risks in specific subsets of patients.
The lawsuit highlights several key components of Novo Nordisk’s strategy, including the improper listing of device patents in the Food and Drug Administration’s Orange Book. This action allegedly triggered regulatory delays aligned with provisions under the Hatch-Waxman Act, a federal statute governing generic drug approvals. Moreover, the complaint scrutinizes a 2019 settlement agreement between Novo Nordisk and Teva Pharmaceutical Industries Ltd., noted as the first potential producer of generic Victoza. This deal allegedly included an impermissible reverse payment, which postponed Teva’s generic launch until June 24, 2024, while granting it exclusive sales rights for the initial 180 days after launch.
The plaintiffs further assert that Novo Nordisk actively impeded other generic manufacturers from challenging the contested patents, effectively preventing the U.S. Food and Drug Administration from approving additional competing generics until after Teva’s exclusivity period concluded. Collectively, these alleged actions resulted in at least a 16-month delay in generic Victoza availability. This delay preserved Novo Nordisk’s monopoly pricing power and permitted both Novo and Teva to maintain supracompetitive pricing levels in the market, as stated in the lawsuit.
According to the complaint, this scheme compelled purchasers—including wholesalers, pharmacies, and patients—to pay inflated prices not only for original Victoza and its eventual generics but also for Ozempic. The plaintiffs argue that demand for Ozempic would have been diminished had generic Victoza become accessible in a timely manner, due to the availability of a less expensive alternative fulfilling a similar therapeutic role.
The legal action aims to secure compensation exceeding hundreds of millions of dollars, representing alleged overpayments tied to purchases of Victoza, generic versions thereof, and Ozempic occurring throughout the period affected by the purported delay.
As of the latest available trading data at the time of filing, Novo Nordisk’s stock price was reported at $58.82 per share, reflecting a decrease of approximately 0.87% on that trading day. Concurrently, Teva Pharmaceutical Industries Ltd., linked to the settlement agreement in question, traded at $32.55, down 1.59%.
The dispute underscores significant regulatory, legal, and market dynamics within the pharmaceutical sector, particularly related to patent protections, market exclusivities, and pricing strategies for high-demand specialty drugs. The outcome of this litigation may have notable implications for pricing, accessibility, and competition in the diabetes treatment market segment.