Protecting Consumer Access to Generic Drugs Act of 2019
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Protecting Consumer Access to Generic Drugs Act of 2019
This bill prohibits the manufacturer of a brand-name, generic, or biosimilar drug from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product.
Specifically, such an agreement shall, with some exceptions, be a violation of the bill if the filer of a subsequent application to market a drug or biological product receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the subsequent drug or biological product. (Typically, a subsequent application seeks to market a generic or biosimilar version of a patented drug or biological product.)
Penalties for violations of the bill include civil penalties and loss of the 180-day exclusivity period for a generic drug. The Federal Trade Commission (FTC) shall have exclusive authority to litigate to enforce the bill.
When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains (1) the complete agreement; and (2) any agreements related to the main agreement, including descriptions of any oral agreements or representations.
Placed on the Union Calendar, Calendar No. 30.
- Introduced in House Formatted Text PDF Formatted XML
- Reported in House Formatted Text PDF Formatted XML
Cite this page
U.S. Congress. (2026). H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-HR-1499/
"H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-1499/.
H.R. 1499, 116th Cong. (2026), https://openamerica.io/bill/116-HR-1499/.
[H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019](https://openamerica.io/bill/116-HR-1499/)