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Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986–2019.

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Titel: Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986–2019.
Autoren: Olsen, Anders, Beall, Reed F., Knox, Ryan P., Tu, Sean S., Kesselheim, Aaron S., Feldman, William B.
Quelle: PLoS Medicine; 11/16/2023, Vol. 20 Issue 11, p1-19, 19p
Schlagwörter: INSULIN, PATENT applications, PATENTS, DRUG accessibility, TYPE 2 diabetes, INSULIN pumps
Firma/Körperschaft: UNITED States. Food & Drug Administration
Abstract: Background: Insulin is the primary treatment for type 1 and some type 2 diabetes but remains costly in the United States, even though it was discovered more than a century ago. High prices can lead to nonadherence and are often sustained by patents and regulatory exclusivities that limit competition on brand-name products. We sought to examine how manufacturers have used patents and regulatory exclusivities on insulin products approved from 1986 to 2019 to extend periods of market exclusivity. Methods and findings: We used the publicly available Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) to identify all approved biosynthetic insulin products. Individual products approved under the same New Drug Application (NDA)—e.g., a vial and pen—were considered as separate products for the purposes of analysis. We recorded all patents and regulatory exclusivities listed in the Orange Book on each product and used Google Patents to extract the timing of patent application and whether patents were obtained on delivery devices or others aspects of the product. The primary outcome was the duration of expected protection, which was determined by subtracting the FDA approval date for each product from its last-to-expire patent or regulatory exclusivity (whichever occurred later). We performed a secondary analysis that considered overall protection on insulin lines—defined as groups of products approved under the same NDA with the same active ingredients manufactured by the same company. We also examined competition from follow-on insulin products—defined as products approved with the same active ingredients as originators but manufactured by different companies (approved via a specific drug approval pathway under section 505(b)(2) of the Food, Drug, and Cosmetic Act). During the study period, the FDA approved 56 individual products across 25 different insulin lines and 5 follow-ons across 3 different insulin lines. Thirty-three (59%) of the 56 products were drug-device combinations. Manufacturers of 9 products approved during the study period obtained patents filed after FDA approval that extended their duration of expected protection (by a median of 6 years). Approximately 63% of all patents on drug-device combinations approved during the study period were related to delivery devices. The median duration of expected protection on insulin products was 16.0 years, and the median protection on insulin lines was 17.6 years. An important limitation of our analysis is that manufacturers may continue to add patents on existing insulin products while competitors may challenge patents; therefore, periods of protection may change over time. Conclusions: Among several strategies that insulin manufacturers have employed to extend periods of market exclusivity on brand-name insulin products are filing patents after FDA approval and obtaining a large number of patents on delivery devices. Policy reforms are needed to promote timely competition in the pharmaceutical market and ensure that patients have access to low-cost drugs. Anders Olsen and colleagues explore patenting on insulin products by the Federal Drug Agency (FDA) and the impact on market exclusivity and drug prices. Author summary: Why was this study done?: Patents and regulatory exclusivities on brand-name drugs can support high prices by limiting competition. We sought to describe how manufacturers have used patents and regulatory exclusivities on insulin products approved in the United States from 1986 to 2019 to establish periods of market exclusivity. What did the researchers find?: The Food and Drug Administration (FDA) approved 56 brand-name originator insulin products during the study period. The median duration of expected patent protection on these products was 16.0 years. Insulin manufacturers have extended periods of market exclusivity by filing many patents on their products, including many after FDA approval. Of all patents on the 33 drug-device combinations in the cohort, 63% were related to delivery devices. What do these findings mean?: Policy reforms are needed to promote competition in the pharmaceutical market and ensure that patients have timely access to drugs at fair prices. A limitation of this work is that realized periods of market exclusivity may shift in the future, because brand-name firms may add more patents over time and competitors may challenge existing patents. [ABSTRACT FROM AUTHOR]
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Datenbank: Complementary Index
Beschreibung
Abstract:Background: Insulin is the primary treatment for type 1 and some type 2 diabetes but remains costly in the United States, even though it was discovered more than a century ago. High prices can lead to nonadherence and are often sustained by patents and regulatory exclusivities that limit competition on brand-name products. We sought to examine how manufacturers have used patents and regulatory exclusivities on insulin products approved from 1986 to 2019 to extend periods of market exclusivity. Methods and findings: We used the publicly available Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) to identify all approved biosynthetic insulin products. Individual products approved under the same New Drug Application (NDA)—e.g., a vial and pen—were considered as separate products for the purposes of analysis. We recorded all patents and regulatory exclusivities listed in the Orange Book on each product and used Google Patents to extract the timing of patent application and whether patents were obtained on delivery devices or others aspects of the product. The primary outcome was the duration of expected protection, which was determined by subtracting the FDA approval date for each product from its last-to-expire patent or regulatory exclusivity (whichever occurred later). We performed a secondary analysis that considered overall protection on insulin lines—defined as groups of products approved under the same NDA with the same active ingredients manufactured by the same company. We also examined competition from follow-on insulin products—defined as products approved with the same active ingredients as originators but manufactured by different companies (approved via a specific drug approval pathway under section 505(b)(2) of the Food, Drug, and Cosmetic Act). During the study period, the FDA approved 56 individual products across 25 different insulin lines and 5 follow-ons across 3 different insulin lines. Thirty-three (59%) of the 56 products were drug-device combinations. Manufacturers of 9 products approved during the study period obtained patents filed after FDA approval that extended their duration of expected protection (by a median of 6 years). Approximately 63% of all patents on drug-device combinations approved during the study period were related to delivery devices. The median duration of expected protection on insulin products was 16.0 years, and the median protection on insulin lines was 17.6 years. An important limitation of our analysis is that manufacturers may continue to add patents on existing insulin products while competitors may challenge patents; therefore, periods of protection may change over time. Conclusions: Among several strategies that insulin manufacturers have employed to extend periods of market exclusivity on brand-name insulin products are filing patents after FDA approval and obtaining a large number of patents on delivery devices. Policy reforms are needed to promote timely competition in the pharmaceutical market and ensure that patients have access to low-cost drugs. Anders Olsen and colleagues explore patenting on insulin products by the Federal Drug Agency (FDA) and the impact on market exclusivity and drug prices. Author summary: Why was this study done?: Patents and regulatory exclusivities on brand-name drugs can support high prices by limiting competition. We sought to describe how manufacturers have used patents and regulatory exclusivities on insulin products approved in the United States from 1986 to 2019 to establish periods of market exclusivity. What did the researchers find?: The Food and Drug Administration (FDA) approved 56 brand-name originator insulin products during the study period. The median duration of expected patent protection on these products was 16.0 years. Insulin manufacturers have extended periods of market exclusivity by filing many patents on their products, including many after FDA approval. Of all patents on the 33 drug-device combinations in the cohort, 63% were related to delivery devices. What do these findings mean?: Policy reforms are needed to promote competition in the pharmaceutical market and ensure that patients have timely access to drugs at fair prices. A limitation of this work is that realized periods of market exclusivity may shift in the future, because brand-name firms may add more patents over time and competitors may challenge existing patents. [ABSTRACT FROM AUTHOR]
ISSN:15491277
DOI:10.1371/journal.pmed.1004309