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Last Updated: February 27, 2021

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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
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-001 Feb 20, 2008 OTC Yes Yes   Start Trial   Start Trial Y
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-002 Nov 5, 2012 OTC Yes No   Start Trial   Start Trial Y
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes   Start Trial   Start Trial Y
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 RX Yes Yes   Start Trial   Start Trial METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 RX Yes Yes   Start Trial   Start Trial METHOD FOR ADMINISTERING PIRFENIDONE WHILE AVOIDING OR DISCONTINUING CONCOMITANT USE OF A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME INVOLVED IN PIRFENIDONE METABOLISM
>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
McKinsey
Colorcon
Express Scripts
Boehringer Ingelheim
McKesson

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