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Last Updated: April 13, 2024

Regulatory Exclusivity Expiring in 2029


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Drugs with Regulatory Exclusivity Expiring in 2029

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Lnhc ZELSUVMI berdazimer sodium GEL;TOPICAL 217424-001 Jan 5, 2024 RX Yes Yes ⤷  Try a Trial NEW CHEMICAL ENTITY
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-002 Jan 7, 2022 RX Yes No ⤷  Try a Trial TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 14 KG TO LESS THAN 25 KG
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-001 Feb 17, 2022 RX Yes No ⤷  Try a Trial TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-002 Feb 17, 2022 RX Yes No ⤷  Try a Trial TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-003 Feb 17, 2022 RX Yes Yes ⤷  Try a Trial TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
Cti Biopharma Corp VONJO pacritinib citrate CAPSULE;ORAL 208712-001 Feb 28, 2022 RX Yes Yes ⤷  Try a Trial TREATMENT OF ADULTS WITH INTERMEDIATE OR HIGH-RISK PRIMARY OR SECONDARY (POST-POLYCYTHEMIA VERA OR POST-ESSENTIAL THROMBOCYTHEMIA) MYELOFIBROSIS (MF) WITH A PLATELET COUNT BELOW 50 X 10^9/L
Nobelpharma HYFTOR sirolimus GEL;TOPICAL 213478-001 Mar 22, 2022 RX Yes Yes ⤷  Try a Trial TREATMENT OF FACIAL ANGIOFIBROMA ASSOCIATED WITH TUBEROUS SCLEROSIS IN ADULTS AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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