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Last Updated: October 25, 2020

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET, TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes   Start Trial   Start Trial Y
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No   Start Trial   Start Trial Y Y
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes   Start Trial   Start Trial TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-004 Feb 16, 2018 RX Yes Yes   Start Trial   Start Trial TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes   Start Trial   Start Trial Y Y
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes No   Start Trial   Start Trial TREATMENT OF MARGINAL ZONE LYMPHOMA
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-004 Feb 16, 2018 RX Yes Yes   Start Trial   Start Trial TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Medtronic
AstraZeneca
McKinsey
Dow

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