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

 

If you have any query/suggestion then please write us at pharmacaption@gmail.com

NEWS 25 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
Budesonide inhalation suspension	Lupin	Pulmicort Repsules (Astra Zeneca)	$385.4 Million	Link
Solifenacin Succinate tablets	Apotex	Vesicare (Astellas)	N/A	Link

 

NDA APPROVALS

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
23 May 2019	Alpelisib tablets	Novartis	Piqray	Link

 

505(b)2 APPROVALS

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
23 May 2019	Drospirenone 4mg tablets	Exeltis (Insud Pharma)	Slynd*	Link
20 May 2019	Fulvestrant injection#	Fresenius Kabi	N/A	N/A

 

*Difference between Yaz and Slynd

-      Yaz contains combination of Drospirenone (3mg) and Ethinyl Estradiol (0.02mg), while Slynd contains only Drospirenone (4mg).

-      Both of them are used for contraception.

-      Dosing pattern of Slynd is similar to Yaz that includes administration of Drospirenone containing tablets once daily for 24 days followed by administration of placebo tablets for 4 days.

-      Yaz prescribing information: Link

-      Slynd Prescribing information: Link

 

^#US granted patents on Fulvestrant by Fresenius

-      US 10188663; US 9833459; US 9271990

Tentative 505(b)2 APPROVALS

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
23 May 2019	Pemetrexed disodium injections	Biocon	N/A	N/A

 

505(b)2 IN PIPELINE

Ethinyl Estradiol/Levonorgestrol Transdermal patch (Agile therapeutics): Agile Therapeutics Announces FDA Acceptance of the NDA Resubmission of Ethinyl Estradiol/Levonorgestrol Transdermal patch (Twirla)

-         Agile Therapeutics  announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) resubmission for Twirla^® (AG 200-15). It’s a hormonal contraceptive patch.

-         PDUFA goal date is 16 Nov. 2019.

-         The patch is designed to apply once weekly for three weeks, followed by a week without patch.

-         Full Press release: Link

AV001- injectable unapproved marketed product (Avadel Pharmaceuticals): Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for AV001

-         Avadel Pharmaceuticals announced that the USFDA has accepted the New Drug Application (NDA) for the Company’s fourth Hospital Product, AV001.

-         It’s a sterile injectable unapproved marketed drug for which Avadel has submitted 505(b)2 NDA application.

-         As per company’s press release, subsequent to their NDA submission, the FDA granted an NDA approval for a parenteral product with the same Active Pharmaceutical Ingredient (API) as AV001.

-         PDUFA goal Date: September 15, 2019.

-         Press  Release: Link

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
17 May 2019	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate ER Capsules	Rhodes Pharms	Adderall XR (Shire)	Seven
20 May 2019	Dactinomycin Injection	X-Gen Pharms	Cosmegen (Recordati)	One (Mylan)
20 May 2019	Albendazole Tablets	Actavis	Albenza (Impax)	Four
20 May 2019	Solifenacin Succinate Tablets	Watson Labs	Vesicare (Astellas)	More Than 10
20 May 2019	Solifenacin Succinate Tablets	Alembic Pharms
20 May 2019	Solifenacin Succinate Tablets	Glenmark
20 May 2019	Solifenacin Succinate Tablets	Qilu Pharm
20 May 2019	Solifenacin Succinate Tablets	Amneal Pharms
20 May 2019	Solifenacin Succinate Tablets	Breckenridge Pharm
20 May 2019	Solifenacin Succinate Tablets	Cipla
20 May 2019	Solifenacin Succinate Tablets	Alkem
20 May 2019	Solifenacin Succinate Tablets	Jiangxi Boya
20 May 2019	Solifenacin Succinate Tablets	Airis Pharma
20 May 2019	Solifenacin Succinate Tablets	Msn Labs
20 May 2019	Solifenacin Succinate Tablets	Sciegen P
20 May 2019	Methylprednisolone Acetate injection	Amneal Pharms	Depo-Medrol (Pharmacia And Upjohn)	Five
21 May 2019	Dalfampridine ER Tablets	Sun Pharm	Ampyra (Acorda)	Six
22 May 2019	Esomeprazole Magnesium DR Pellets Capsules	Zydus	Nexium (Astrazeneca)	Ten
22 May 2019	Phytonadione Injection	Dr Reddys	N/A	One (Hospira)
22 May 2019	Trientine Hydrochloride Capsules	Msn Labs	Syprine (Aton)	Four
22 May 2019	Cyproheptadine Hydrochloride Syrup	Quagen	N/A	Five

 

 

TENTATIVE ANDA APPROVALS

Approval Date	Drug	Company
16 May 2019	Cabazitaxel	Mylan
16 May 2019	Rivaroxaban	Prinston
16 May 2019	Dolutegravir	Laurus  Labs
20 May 2019	Pemetrexed	Teva Pharms
20 May 2019	Dimethyl Fumarate	Sun Pharm
20 May 2019	Solifenacin Succinate	Ajanta Pharma
22 May 2019	Erlotinib	Accord Hlthcare

If you have any query/suggestion then please write us at pharmacaption@gmail.com