NEWS 31 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
Ranolazine ER tablets	Teva	Ranexa (Gilead)	$938 Million	Link
Methylphenidate ER tablets	Lannett*	Concerta (Janssen)	$1.4 Billion	Link
Fulvestrant injection	Sandoz	Faslodex (Astra Zeneca)	$541 Million	Link

*ANDA holder for Lannett’s product is Andor pharmaceuticals

 

505(b)2 IN PIPELINE

Risperidone ER microsphere (Luye Pharma): Luye Pharma’s Rykindo^®(Risperidone ER microsphere) NDA Filing Accepted by the U.S. FDA.

-      As per Luye pharma, Rykindo^®’s dosage strengths intended for market are 12.5 mg, 25 mg, 37.5 mg, and 50 mg of Risperidone per vial.

-      The drug is administered once every two weeks by intramuscular injection to treat schizophrenia and bi-polar disorder.

-      We have reported Luye pharma’s NDA submission for Rykindo^® back in March here

-      Press Release: Link

 

GENERIC PATENT LITIGATIONS

Carfilzomib Injection (Natco V. Onyx): Natco has reached Settlement Agreement with Onyx Therapeutics, Inc. on patent litigation related to generic versions of 10mg, 30mg and 60mg of Kyprolis.

-      Natco is the sole first filer for 10mg strength.

-      Permitted launch date to Natco (Breckenridge) in the license: 2027 or earlier

-      Press release: Link

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
23 May 2019	Methylphenidate Hydrochloride ER Capsules	Granules India	Ritalin LA (Novartis)	Two (Barr Lab, Mayne Pharma)
27 May 2019	Aspirin And ER Dipyridamole Capsules	Glenmark	Aggrenox (Boehringer)	Nine
23 May 2019	Fluoxetine Hydrochloride Capsules	Cadila	Prozac (Eli Lilly)	More Than 10
23 May 2019	Potassium Chloride Solution	Amneal Pharma	Potassium Chloride (Pharma Res)	Four
23 May 2019	Clobazam Tablets	Accord	Onfi (Lundbeck)	More Than 10
28 May 2019	Melphalan Hydrochloride Injection	Gland Pharma	Alkeran (Apotex)	Nine
28 May 2019	Ranolazine ER Tablets	Actavis Elizabeth	Ranexa (Gilead)	Four
28 May 2019	Ranolazine ER Tablets	Cipla
28 May 2019	Ranolazine ER Tablets	Sun Pharm
28 May 2019	Ranolazine ER Tablets	Ajanta
28 May 2019	Heparin Sodium Injection	Nanjing King	Heparin Sodium (Fresenius)	More Than 10
29 May 2019	Dapiprazole Hydrochloride Ophthalmic Solution*	Baradaina	Dapiprazole Hydrochloride (Fera Pharma)	None

*This is first generic approval for Dapiprazole. It is an off-patent off- exclusivity product.

 

USFDA INSPECTIONS

Dr. Reddy’s Laboratories (API manufacturing facility, Miryalaguda): Dr. Reddy’s Laboratories provided update on USFDA inspection at company’s API manufacturing facility.

Full Press Release: Link

 

NEWS FROM EUROPE

Teriparatide (Alvogen/Pfenex): Alvogen and Pfenex Announce Acceptance of Marketing Authorization Application for Teriparatide biosimilar. 

Full Press Release: Link

 

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