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25 Mar 2024, 4:36 am by Dennis Crouch
Teva & Apotex’s Arguments Against Certiorari Vanda forfeited its “predictability” argument by not raising it below. [read post]
19 Feb 2024, 12:55 pm by Dennis Crouch
  Teva and Apotex, filed Abbreviated New Drug Applications (ANDAs) with the FDA seeking to market generic versions of the $100m+ drug. [read post]
4 Feb 2024, 11:54 am by Alastair Clarke
They are then forced to spend the time to review the application history, review the 8-step legal test set out in Apotex and make a decision re the duty to perform. [read post]
19 Jan 2024, 4:00 am by Alan Macek
In other contexts, there have been concerns that double patenting may increase burdens under the Notice of Compliance regime for pharmaceuticals – see for example, Glaxosmithkline Inc. v Apotex Inc, 2003 FCT 687 at 90: “The existence of additional patents allows the patent-holder to bring additional applications, thereby obtaining multiple injunctive periods. [read post]
1 Dec 2023, 4:00 am by Martin Kratz
How far such edits must go is put in doubt by the Federal Court of Appeal decision in Apotex Inc. v. [read post]
27 Oct 2023, 6:17 am by Searcy Law
On March 2, 2023, Apotex Corp. issued a recall due to “cracks that have developed” in some of the bottles used to store its Apotex-brand eye drops. [read post]
27 Oct 2023, 6:17 am by Searcy Law
On March 2, 2023, Apotex Corp. issued a recall due to “cracks that have developed” in some of the bottles used to store its Apotex-brand eye drops. [read post]
27 Oct 2023, 6:17 am by Searcy Law
On March 2, 2023, Apotex Corp. issued a recall due to “cracks that have developed” in some of the bottles used to store its Apotex-brand eye drops. [read post]
17 Aug 2023, 9:00 pm by Kurt R. Karst
  Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. [read post]