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Last Updated: July 12, 2020

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Regulatory Exclusivity Expiring in 2026


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Drugs with Regulatory Exclusivity Expiring in 2026

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Astrazeneca Pharms LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes   Start Trial MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC
Astrazeneca Pharms LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No   Start Trial MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC
Dutch Ophthalmic TISSUEBLUE brilliant blue g SOLUTION;OPHTHALMIC 209569-001 Dec 20, 2019 RX Yes Yes   Start Trial INDICATED TO SELECTIVELY STAIN THE INTERNAL LIMITING MEMBRANE (ILM)
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes   Start Trial INDICATED FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING
Global Blood Theraps OXBRYTA voxelotor TABLET;ORAL 213137-001 Nov 25, 2019 RX Yes Yes   Start Trial INDICATED FOR THE TREATMENT OF SICKLE CELL DISEASE (SCD) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes   Start Trial INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
McKinsey
Merck
Mallinckrodt
AstraZeneca

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