💊FDA Announces Regulatory Review Period for LAZCLUZE Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LAZCLUZE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Learn More💊FDA Notice on Patent Extension for KISUNLA Regulatory Review
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KISUNLA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💊FDA Patent Extension Review for TECELRA and Business Implications
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TECELRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💊FDA Notice on Regulatory Review Period for ABRYSVO Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ABRYSVO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💊FDA Regulatory Review Period for HEMGENIX Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for HEMGENIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💊FDA Announces Regulatory Review Period for IMDELLTRA Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMDELLTRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💊FDA Notice on Patent Extension for REBYOTA Drug
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REBYOTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💊FDA Patent Extension Notice for WINREVAIR
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for WINREVAIR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More🦴FDA Patent Extension for TOTAL POSTERIOR SPINE SYSTEM
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TOTAL POSTERIOR SPINE SYSTEM (TOPS SYSTEM) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Learn More💊FDA Corrects Regulatory Review Period for ELREXFIO Patent
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on May 12, 2025. The document, entitled "Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO," announced the determination of the regulatory review period for ELREXFIO (elranatamab-bcmm) for purposes of patent extension. The document was published with only one of two docket numbers. This document corrects that error.
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