NEWS 14 July 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

LAUNCH DATE	DRUG	Marketer	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
10 July 2019	Cinacalcet tablets	Aurobindo	Sensipar (Amgen)	$1449 Million	Link

NEW EXCLUSIVITY LISTINGS IN THE ORANGE BOOK

New PC (Patent Challenge) exclusivity listing in the orange book

Drug	Applicant	Corresponding RLD	PC exclusivity expiration date	Other TA holders
Dexmedetomidine injection (80 mcg/20 ml)	Fresenius Kabi	Precedex (Hospira)	30 Nov. 2019	Amneal
Treprostinil injection	Sandoz	Remodulin (United Therapeutics)	21 Sep. 2019	Par

New CGT (competitive generic therapy) exclusivity listing in the orange book

Drug	Applicant	Corresponding RLD	CGT exclusivity expiration date
Carboprost injection	Dr. Reddy’s Laboratories	Hemabate (Wyeth)	29 Dec. 2019
Penicillamine capsules*	Watson	Cuprimine (Bausch health)	22 Dec. 2019

*Amerigen has received final approval for Penicillamine capsules one month before Watson. Hence, till CGT expiration date only Watson and Amerigen will remain as generic players in the US.

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
9 July 2019	Risedronate delayed release tablets	Sun Pharma	Atelvia (Allergan)	Three (Two discontinued)
10 July 2019	Cyclosporine capsules	Apotex	Neoral (Novartis)	Four
10 July 2019	Omega-3 fatty acid ethyl ester	Sofgen pharma	Lovaza (Smithkline Beecham)	Six
10 July 2019	Abiraterone acetate tablets	MSN labs	Zytiga (Janssen)	Seven
10 July 2019	Clobazam oral suspension	Vistapharm	Onfi (Lundbeck)	Seven

OTHER NEWS FROM US

FDA issued draft guidance on using the inactive ingredient database.

Link to guidance here

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