NEWS 27 June 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

LAUNCH DATE	DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
18 June 2019	Aspirin & ER Dipyridamole capsules	Lannett	Aggrenox (Boehringer)	$158 Million	Link
18 June 2019	Mesalamine suppository	Rising Pharma	Canasa (Allergan)	$263 Million	Link
22 June 2019	Phytonadione injectable emulsion	Dr. Reddy’s laboratories	Vitamin K1 (Hospira)	$46.6 Million	Link
25 June 2019	Tobramycin inhalation solution	Dr. Reddy’s laboratories	Tobi (Mylan)	$97 Million	Link
25 June 2019	Ranitidine capsules	ANI pharma	Zantac (GSK)	$40 Million	Link

 

NDA APPROVALS

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
21 June 2019	Bremelanotide Injection	Amag Pharms	Vyleesi	Link

 

GENERIC PATENT LITIGATIONS

Fingolimod (Novartis v. Accord et al): Novartis has won a U.S. federal court order preventing rival generic makers from selling versions of Gilenya in the United States, at least until a patent dispute is resolved. Affected generic players include Dr. Reddy’s, Aurobindo, Zydus, Torrent and others.

 

Read More: Link

 

Rotigotine Transdermal film (UCB v. Teva): Upper court in US affirms lower court’s decision that Teva’s generic Rotigotine infringes UCB patent expiring in 2021.

 

Read More: Link

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
19 June 2019	Scopolamine ER Transdermal Film	Mylan	Transderm Scop (GSK)	One (Perrigo)
19 June 2019	Bimatoprost Ophthalmic Solution	Somerset	Lumigan (Allergan)	Six
20 June 2019	Sodium Bicarbonate Injection	Exela Pharma	Sodium Bicarbonate (Abbott Lab)	Two
20 June 2019	Ganciclovir Sodium Injection	Custopharm	Cytovene (Roche Palo)	Five
21 June 2019	Dextroamphetamine Sulfate ER Capsules	Pii	Dexedrine (Impax)	Six
21 June 2019	Mesalamine Suppository	Amring	Canasa (Allergan)	Three
21 June 2019	Bromfenac Sodium Ophthalmic Solution	Alembic Pharms	Xibrom (Bausch and Lamb)	Two

 

OTHER NEWS FROM USA

FDA updates list of off-patent, off-exclusivity drugs without generic competition

 

Read more: Link

 

Full updated list of off-patent, off-exclusivity drugs without generic competition: Link

 

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