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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