NEWS 31 Mar. 2019

NEWS FROM USA

505(b)2s in pipeline

Risperidone ER Microsphere (Luye Pharma): Luye Pharma announced NDA submission of Risperidone ER microsphere.

Leuprolide mesylate 6 months depot (Foresee Pharma): Foresee pharma announced NDA submission of Leuprolide mesylate ready to use 6 months depot formulation

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Tadalafil Tablets	Apotex	Cialis (Eli Lilly)	N/A	Link

 

NDA Approvals                    

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
29 Mar 2019	Aclidinium Bromide; Formoterol Fumarate Dihydrate Power	Astrazeneca	Duaklir Pressair	Link

 

ANDA Approvals

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
28 Mar 2019	Ambrisentan Tablets	Zydus	Letairis (Gilead)	Three
28 Mar 2019	Ambrisentan Tablets	Watson
28 Mar 2019	Ambrisentan Tablets	Mylan
28 Mar 2019	Ambrisentan Tablets	Sun Pharm
28 Mar 2019	Levocetirizine Dihydrochloride Tablets	Perrigo	Xyzal Allergy 24 HR (Sanofi)	Two
28 Mar 2019	Doxepin Hydrochloride Capsules	Aurobindo Pharma	N/A	Three

 

GENERIC PATENT LITIGATIONS

Tapentadol (Assertio Therapeutics): Assertio Therapeutics Announces Favorable NUCYNTA CAFC Patent Ruling.

Lenaliomide (Celgene v. Alvogen): Celgene Settles U.S. REVLIMID Patent Litigation with Alvogen.

NEWS FROM EUROPE

Tadalafil (Actavis v. ICOS): UK supreme court rules in favour of generics in Tadalafil patent case.

 

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NEWS 29 MAR 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Tadalafil Tablets	Dr Reddys	Cialis (Eli Lilly)	$1.7 Billion	Link
	Zydus			Link
Fluocinonide Ointment	Lupin	Lidex (County Line Pharma)	$15 Million	Link

 

NDA Approvals                    

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
27 Mar 2019	Siponimod	Novartis	Mayzent	Link
27 Mar 2019	Testosterone Undecanoate Capsules	Clarus Therapeutics	Jatenzo	Link

 

ANDA Approvals

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
26 Mar 2019	Entecavir Tablets	Mylan	Baraclude (BMS)	More Than 10
26 Mar 2019	Aspirin And Extended-Release Dipyridamole Capsules	Lannett	Aggrenox (Boehringer)	Eight
26 Mar 2019	Tadalafil Tablets	Unichem Lab	Cialis (Eli Liiiy)	More Than 10
26 Mar 2019	Tadalafil Tablets	Alembic Pharma
26 Mar 2019	Tadalafil Tablets	Lupin
26 Mar 2019	Tadalafil Tablets	Aurobindo Pharma
26 Mar 2019	Tadalafil Tablets	Sun Pharma
26 Mar 2019	Tadalafil Tablets	Accord Healthcare
26 Mar 2019	Tadalafil Tablets	Cipla
26 Mar 2019	Tadalafil Tablets	Ajanta Pharma
26 Mar 2019	Tadalafil Tablets	Amneal
26 Mar 2019	Tadalafil Tablets	Hetero
26 Mar 2019	Tadalafil Tablets	Qilu
26 Mar 2019	Tadalafil Tablets	Sunshine Lake
26 Mar 2019	Tadalafil Tablets	Torrent
26 Mar 2019	Tizanidine Hydrochloride Capsule	Cadila Pharma	Zanaflex (Covis)	Five
26 Mar 2019	Cephalexin Oral Suspension	Alkem	N/A	Four

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
27 Mar 2019	Atazanavir;Cobicistat	Mylan

 

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NEWS 26 MAR 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Treprostinil Injection	Sandoz*	Remodulin	$599 Million (As per the last annual report)	Link
Deferasirox Tablets	Teva#	Exjade	$134 Million	Link

*As per the press release, Sandoz has received 180 days exclusivity for this product.

#As per the final approval letter, Teva is eligible for 180 days exclusivity. However, the only exclusivity bearing patent is set to expire on 5 Apr. 2019 and in absence of any paediatric extension, there is a possibility that at least one subsequent filer may launch its product on or after 6 Apr. 2019.

 

ANDA Approvals

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
25 Mar 2019	Hydroxyprogesterone Caproate Injection	Slaybsck Pharma	Makena Preservative Free (Amag Pharma)	One (Luitpold)
25 Mar 2019	Sildenafil Tablets	Lupin	Viagra Tablets (Pfizer)	Seven
22 Mar 2019	Drospirenone; Ethinyl Estradiol Tablets	Hetero	Yaz (Bayer)	Ten
22 Mar 2019	Bimatoprost Solution	Gland Pharma	N/A	Four
22 Mar 2019	Roflumilast Tablets	Micro Labs	Daliresp (Astrazeneca Pharms)	Three
22 Mar 2019	Aliskiren Hemifumarate Tablets	Anchen Pharms	Tekturna (Noden)	None
21 Mar 2019	Lamivudine Tablets	Annora	Epivir-Hbv (GSK)	Three
20 Mar 2019	Glycopyrrolate Injection	Caplin	N/A	Nine
20 Mar 2019	Methylergonovine Maleate Tablets	Teva Pharms	N/A	Three

 

Tentative NDA Approvals 

Approval Date	Drug	Company
25 Mar 2019	Dolutegravir;Lamivudine;Tenofovir Disoproxil Fumarate	Macleods

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
22 Mar 2019	Dimethyl Fumarate	Msn Lab
25 Mar 2019	Dimethyl Fumarate	Sawai Usa
25 Mar 2019	Lurasidone Hydrochloride	Piramal Healthcare
25 Mar 2019	Armodafinil	Apotex

 

USFDA Inspections

Sun Pharma (Baska Plant): Sun pharma gets FDA Observation for Baska Plant.

 

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