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ANDA Litigation Settlements
Fall 2016
| Case Name | Drug | Patent No(s). | Publicly Available Terms |
|---|---|---|---|
| AstraZeneca Pharms. LP v. Sagent Pharms. Inc., 14-3547 (D.N.J.) | Faslodex® (fulvestrant for injection) |
6,774,122
7,456,160
8,329,680
8,466,139
|
The patents-in-suit remain valid until they expire in January 2021.
Sandoz may launch its generic ANDA product on Mar. 25, 2019, or earlier under undisclosed circumstances.
|
| Allos Therapeutics Inc. v. Teva Pharms. USA Inc., 14-0778 (D. Del.) | Folotyn® (pralatrexate) |
6,028,071
7,622,470
8,299,078
|
Fresenius Kabi USA LLC would be allowed to market its ANDA product in the U.S. starting Nov. 15, 2022, or earlier under certain circumstances. |
| Celgene Corp. v. Teva Pharms. USA Inc., 15-1143 (D. Del.) | Istodax® (romidepsin) |
7,608,280
7,611,724
|
N/A |
| Teva Pharmas. USA Inc. v. Forest Labs. Inc., 13-2002 (D. Del.) | Namenda XR® (memantine hydrochloride extended-release capsules) | 6,194,000 | N/A |
| Cosmo Technologies Ltd. v. Par Pharms. Inc., 15-0116 (D. Del.) | Uceris® (budesonide) |
7,410,651
7,431,943
8,293,273
8,784,888
8,895,064
RE43,799
9,192,581
9,320,716
|
Par agrees that the patents-in-suit are valid and enforceable, and it will not market its ANDA product unless authorized by the settlement. |
| Braintree Labs., Inc. v. Novel Labs., Inc., 11-1341 (D.N.J.) | Suprep® Bowel Prep Kit (magnesium sulfate / potassium sulfate / sodium sulfate) | 6,946,149 | N/A |
| In re: Bendamustine Consolidated Cases, 13-2046 (D. Del.) | Treanda® (bendamustine hydrochloride injection) |
8,791,270
8,895,756
|
Licensing and settelement agreements were reached between Cephalon and Sagent, Cephalon and Intas Pharmaceuticals, and Cephalon and Hetero Labs. |
| Gilead Sciences Inc. v. Hetero Drugs Ltd., 16-4938 (D.N.J.) | Truvada® (emtricitabine / tenofovir disoproxil fumarate tablets) |
6,642,245
6,703,396
8,592,397
8,716,264
|
N/A |
| Forest Labs. LLC v. Amneal Pharms. LLC, 15-0756 (D. Del.) | Namzaric® (memantine hydrochloride / donepezil hydrochloride extended-release capsules) |
8,039,009
8,058,291
8,168,209
8,173,708
8,283,379
8,293,794
8,329,752
8,338,485
8,338,486
8,362,085
8,580,858
8,598,233
|
Amneal admits its proposed ANDA productwould infringe the patents-in-suit.
No determinations as to the validity of the patents.
If FDA approves Amneal’s ANDA, Amneal may launch its generic product on Jan. 1, 2025, but under some undisclosed circumstances could be delayed until Jan. 1, 2026.
|
| AbbVie Inc. v. Amneal Pharms. LLC, 16-0398 (D. Del.) | Norvir® (ritonavir tablets) |
7,148,359
7,364,752
|
N/A |
GENERICally Speaking Fall 2016
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