NEWS 24 JAN 2019

NEWS FROM USA

New Paragraph IV filing

DRUG	Dosage form	Corresponding RLD	Date of Submission	Type of Submission (Based on Date)
Ibrutinib (70 mg)	Capsules	Imbruvica	14 Dec. 2018	Post NCE-1 submission for new strength

 

NEW GENERICS LAUNCHES IN THE US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Propofol injectable emulsion	Dr. Reddy’s laboratories	Diprivan	$ 310 millions	Link

 

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
18 Jan 2019	Imatinib Mesylate	Wockhardt	Gleevec (Novartis)	Seven
17 Jan 2019	Imatinib Mesylate	Shilpa Medicare	Gleevec (Novartis)	Seven
18 Jan 2019	Levothyroxine Tablets	Lupin	Synthroid (Abbvie)	Four
18 Jan 2019	Dexmedetomidine Hydrochloride Injection	Cipla	Precedex (Hospira)	Fourteen
18 Jan 2019	Lansoprazole DR Oral Capsule	Alkem Labs	Prevacid (Takeda)	Fourteen
18 Jan 2019	Cyclophosphamide Capsules	Cipla	Cyclophosphamide (West-Ward)	Two (Amerigen, Sti Pharma)
18 Jan 2019	Acyclovir Ointment	Cipla	Zovirax (Valeant)	Nine
22 Jan 2019	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate ER Capsules	Amerigen	Adderall Xr (Shire)	Four
22 Jan 2019	Potassium Chloride ER Tablets	Pii	Klor-Con (Upsher Smith)	Seven
22 Jan 2019	Dofetilide Capsules	Aurobindo	Tikosyn (Pfizer)	Five
22 Jan 2019	Tretinoin Cream	Taro	Retin-A (Valeant Pharms)	One (Perrigo)

           

Tentative ANDA Approvals 

Approval Date	Drug	Company
18 Jan 2019	Esomeprazole Magnesium	Zydus Pharms
18 Jan 2019	Carfilzomib	Apotex
18 Jan 2019	Carfilzomib	Qilu Pharma
18 Jan 2019	Dapagliflozin	Hetero Labs
22 Jan 2019	Abiraterone Acetate	Glenmark

 

 

 

 

 

 

 

 

 

 

 

NEWS RELATED TO GENERIC PATENT LITIGATION

Palonosetron (Helsinn v. Teva): US Supreme court rules in favour of Teva in Palonosetron on-sale bar case.

 

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