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Pharmaceutical Patents Generic Drugs Drug Approvals

Robins Kaplan LLP

ANDA Approvals

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New Drug Applications and 505(B)(2) Applications - This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Smart & Biggar

Update on biosimilars in Canada – October 2019

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The following provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access) that have taken place since our last update in June 2018....more

Robins Kaplan LLP

ANDA Approvals - Winter 2018

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Please see Chart below for more information....more

Smart & Biggar

Rx IP Update - January 2019

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IN THIS ISSUE: -Abbott/Takeda permitted to plead that a third party’s patent would be infringed by alleged non-infringing alternative - PMPRB News: **PMPRB issues a Notice of Hearing for allegations of excessive...more

Robins Kaplan LLP

Generic Launches - Fall 2018

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Please see Chart below for more information. ...more

Smart & Biggar

Rx IP Update - July 2017

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Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Smart & Biggar

Rx IP Update - May 2017

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Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more

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