NEWS 15 May 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Daptomycin Injection	Dr Reddys	Cubicin (Merck Sharp & Dohme)	$640.8 Million	Link

 

GENERIC PATENT LITIGATIONS

-      Everolimus - Afinitor (Novartis v. Hikma): Novartis defeats challenge to validity of Afinitor patent covering renal cell carcinoma (RCC) indication – Reuters

 

-      Abiraterone (J&J v. Amneal et al): Johnson & Johnson (JNJ) Patent on Zytiga is Ruled Invalid by U.S. Appeals Court - Bloomberg

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
07 May 2019	Desvenlafaxine Succinate ER Tablets	Intellipharmaceutics	Pristiq (Pf Prism)	Five
07 May 2019	Rosuvastatin Calcium Tablets	Shandong	Crestor (Ipr)	More Than 20
07 May 2019	Busulfan Injection	Apotex	Busulfex (Otsuka)	Ten
08 May 2019	Eszopiclone Tablets	Breckenridge	Lunesta (Sunovion)	Ten
08 May 2019	Dapsone Tablets	Sai Life	N/A	Seven
09 May 2019	Armodafinil Tablets	Mylan	Nuvigil (Cephalon)	Four
09 May 2019	Mesalamine DR Capsules	Teva	Delzicol (Apil)	None
09 May 2019	Hydroxyprogesterone Caproate Solution	Eugia	Makena (Amag Pharma)	Four
10 May 2019	Sapropterin Dihydrochloride Tablets	Par Pharm	Kuvan (Biomarin)	None
10 May 2019	Chlorthalidone Tablets	Zydus	Tenoretic 50 (Alvogen)	Six
10 May 2019	Dexamethasone Sodium Phosphate Injection	Somerset Thera	N/A	Seven
10 May 2019	Oxybutynin Chloride Tablets	Emcure	Ditropan (Janssen)	Eight
13 May 2019	Risedronate Sodium Tablets	Orchid Pharma	Actonel (Apil)	Five
13 May 2019	Doxorubicin Hydrochloride Injection	Hisun Pharm	Doxorubicin Hydrochloride (Pharmacia And Upjohn)	Three
13 May 2019	Labetalol Hydrochloride Tablets	Cadila Pharms	Trandate (Cnty Line)	Eight
13 May 2019	Neostigmine Methylsulfate Solution	BE Pharms	Bloxiverz (Avadel Legacy)	Seven
14 May 2019	Esomeprazole Magnesium DR Capsules	Glenmark Pharma	Nexium DR Capsuls (AstraZeneca)	Nine

*Highlighted products indicate first generic approval for corresponding RLD.

 

NEWS FROM EUROPE

STADA launches generic Bortezomib ready-to-use solution in 14 European countries

 

-      Comparison of Velcade v. Bortezomib Stada

 

Particular	Velcade	Bortezomib Stada
Dosage form	Lyophilized powder	Ready-to-use solution
Strength	3.5 mg/vial Reconstituted to 2.5 mg/ml for Subcutaneous administration	2.5 mg/ml
Excipients	Mannitol. Reconstituted with saline	Mannitol, sodium chloride and water for injection.
Storage	Room temperature	Refrigerated temperature

 

-      Patent covering lyophilized Bortezomib, mannitol boronic acid ester is set to expire in 2022 in Europe.

-      Full press release: Link

 

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