NEWS 14 APRIL 2019

NEWS FROM USA

 

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
Deferasirox tablets for oral suspension	Actavis	Exjade (Novartis)	5 Apr. 2019	Torrent, Zydus

 

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

Drug	Applicant	Corresponding RLD	CGT exclusivity expiration date
Thiothixene capsules	Novitium	Navane (Pfizer)	2 Oct. 2019

 

New PED (pediatric) exclusivity listing in the orange book

Drug	Innovator	Brand Name	PED exclusivity expiration date
Ivabradine tablets	Amgen	Corlanor	15 Oct. 2020*

*Because of PED, NCE exclusivity of Ivabradine is extended by 6 months. Earlier NCE exclusivity of Ivabradine was set to expire on 15 Apr. 2020.

 

Other exclusivity listing in the orange book

Esketamine (Janssen): NCE* exclusivity listed (As it is enantiomer of previously approve racemic mixture). Earlier Levomilnacipran has also received NCE* exclusivity.

 

NDA APPROVALS

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
11 Apr. 2019	Levothyroxine IV solution#	Fresenius Kabi	Levothyroxine Sodium	Link
12 Apr 2019	Erdafinitib tablets	Janssen	Balversa	Link

#Fresenius’ previous NDA was for lyophilized version of Levothyroxine sodium

 

LEVOTHYROXINE SODIUM IV: Comparison between Fresenius’ newly approved solution and previously approved lyophilized product

 

 

OTHER NEWS FROM US

 

ANDA PORTFOLIO ACQUISITION BY DR.REDDY’S LABORATORIES:

-       Dr. Reddy’s Laboratories announced acquisition of 42 approved, non-marketed ANDAs.

-       The acquired portfolio includes more than 30 injectable products.

-       Addressable market size of these products in the US: $645 Mn.

-       Full press release: Link