BLOCKING Act of 2019
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Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019
This bill modifies provisions related to market exclusivity for a generic drug.
Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.
The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.
Placed on the Union Calendar, Calendar No. 24.
- 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. 938: BLOCKING Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-HR-938/
"H.R. 938: BLOCKING Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-938/.
H.R. 938, 116th Cong. (2026), https://openamerica.io/bill/116-HR-938/.
[H.R. 938: BLOCKING Act of 2019](https://openamerica.io/bill/116-HR-938/)