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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