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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
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 AB RX Yes Yes   Start Trial   Start Trial FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
Ardelyx Inc IBSRELA tenapanor hydrochloride TABLET;ORAL 211801-001 Sep 12, 2019 DISCN Yes No   Start Trial   Start Trial METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION BY ADMINISTERING TENAPANOR
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 2018 RX Yes Yes   Start Trial   Start Trial Y
Evoke Pharma Inc GIMOTI metoclopramide hydrochloride SPRAY, METERED;NASAL 209388-001 Jun 19, 2020 RX Yes Yes   Start Trial   Start Trial Y NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 RX Yes Yes   Start Trial   Start Trial Y
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 RX Yes Yes   Start Trial   Start Trial Y
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No   Start Trial   Start Trial Y
>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:

Baxter
Merck
Boehringer Ingelheim
Mallinckrodt
McKinsey
McKesson

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