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Last Updated: September 28, 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
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-002 Jun 23, 2017 RX Yes Yes   Start Trial   Start Trial PROPHYLAXIS OF PULMONARY EMBOLISM
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-001 Jun 23, 2017 RX Yes No   Start Trial   Start Trial PROPHYLAXIS OF PULMONARY EMBOLISM
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes   Start Trial   Start Trial METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING IVACAFTOR AND LUMACAFTOR
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes   Start Trial   Start Trial TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes   Start Trial   Start Trial METHOD OF TREATING CYSTIC FIBROSIS USING N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE AND 3-(6-(1-2,2-DIFLUOROBENZO[D][1,3]DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOIC ACID
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes   Start Trial   Start Trial TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
>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:

Merck
Baxter
McKesson
AstraZeneca
Express Scripts
Dow

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