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Last Updated: July 12, 2025

Regulatory Exclusivity Expiring in 2028


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Drugs with Regulatory Exclusivity Expiring in 2028

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Strongbridge RECORLEV levoketoconazole TABLET;ORAL 214133-001 Dec 30, 2021 RX Yes Yes ⤷  Try for Free FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE
Astrazeneca Ab WAINUA (AUTOINJECTOR) eplontersen sodium SOLUTION;SUBCUTANEOUS 217388-001 Dec 21, 2023 RX Yes Yes ⤷  Try for Free NEW CHEMICAL ENTITY
Chiesi FILSUVEZ birch triterpenes GEL;TOPICAL 215064-001 Dec 18, 2023 RX Yes Yes ⤷  Try for Free NEW CHEMICAL ENTITY
Global Blood Theraps OXBRYTA voxelotor TABLET, FOR SUSPENSION;ORAL 216157-001 Dec 17, 2021 DISCN Yes No ⤷  Try for Free FOR TREATMENT OF SICKLE CELL DISEASE (SCD) IN PEDIATRIC PATIENTS 4 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE
Global Blood Theraps OXBRYTA voxelotor TABLET;ORAL 213137-002 Oct 14, 2022 DISCN Yes No ⤷  Try for Free FOR TREATMENT OF SICKLE CELL DISEASE (SCD) IN PEDIATRIC PATIENTS 4 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE
Global Blood Theraps OXBRYTA voxelotor TABLET;ORAL 213137-001 Nov 25, 2019 DISCN Yes No ⤷  Try for Free FOR TREATMENT OF SICKLE CELL DISEASE (SCD) IN PEDIATRIC PATIENTS 4 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE
Calliditas TARPEYO budesonide CAPSULE, DELAYED RELEASE;ORAL 215935-001 Dec 15, 2021 RX Yes Yes ⤷  Try for Free TO REDUCE PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) AT RISK OF RAPID DISEASE PROGRESSION, GENERALLY A URINE PROTEIN-TO-CREATININE RATIO (UPCR) > OR = 1.5 G/G
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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