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Wednesday, September 5, 2018

NEWS 05 SEP 2018

 NEWS FROM USA

ANDA Approvals     

DRUG

(Approval date)

ANDA sponsor

Corresponding RLD

Number of other approved generics

Sumatriptan and Naproxen sodium Tablets

(4 Sep. 2018)

Mylan

Treximet

Two

(Sun, Aurobindo)

Efavirenz; emtricitabine; tenofovir disoproxil fumarate

(4 Sep. 2018)

Aurobindo

Atripla

None

Ticagrelor tablets

(4 Sep. 2018)

Watson

Brilinta

None

Potassium chloride ER tablets

(31 Aug. 2018)

Strides

Klor-Con

Six

Acyclovir injection

(31 Aug. 2018)

Zydus

Zovirax

(Discontinued)

Other approved generics are discontinued

Amlodipine/Olmesartan

Tablets

(31 Aug. 2018)

Accord

Azor

Eleven

Arsenic trioxide injection (1 mg/ml)

(31 Aug. 2018)

Fresenius Kabi

Trisenox

(Innovator’s 1mg/ml discontinued)

None

 

New Inter Partes Review petitions filed

DRUG

Patentee

Petitioner

Patents challenged (Petition No.)

Isosulfane Blue

Apicore

Luitpold

US 9353050

(IPR2018-01640)

*Previously Aurobindo has filed IPR challenging the same patent

 

 

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