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Last Updated: October 31, 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
Allergan Inc DURYSTA bimatoprost IMPLANT;OPHTHALMIC 211911-001 Mar 4, 2020 RX Yes Yes   Start Trial   Start Trial Y
Allergan Inc DURYSTA bimatoprost IMPLANT;OPHTHALMIC 211911-001 Mar 4, 2020 RX Yes Yes   Start Trial   Start Trial REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN ANGLE GLAUCOMA(OAG) OR OCULAR HYPERTENSION (OHT) WITH A BIODEGRADABLE BIMATOPROST IMPLANT
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes   Start Trial   Start Trial TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE REFRACTORY TO SYSTEMIC THERAPY
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes   Start Trial   Start Trial TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-004 Feb 16, 2018 RX Yes Yes   Start Trial   Start Trial TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE REFRACTORY TO SYSTEMIC THERAPY
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes   Start Trial   Start Trial TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-004 Feb 16, 2018 RX Yes Yes   Start Trial   Start Trial TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE
>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:

Boehringer Ingelheim
McKinsey
Colorcon
Mallinckrodt
Merck
Medtronic

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