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New ANDA Cases
November 2019
| Case Name | Date Filed | Judge | Drug | Patent No(s). |
|---|---|---|---|---|
| Allergan Sales, LLC v. Ajanta Pharma Ltd., 19-1249 (D. Del.) | July 2, 2019 | Hon. Leonard P. Stark | Bystolic® (nebivolol HCl tablets) | 6,545,040 |
| Teva Pharms. Int’l Gmbh v. Lupin, Ltd., 19-1251 (D. Del.) | July 2, 2019 | Hon. Colm F. Connolly | Bendeka® (bendamustine HCl for injection) | 8,609,707 9,265,831 9,572,796 9,572,797 9,034,908 9,144,568 9,572,887 9,597,397 9,597,398 9,597,399 9,000,021 9,579,384 10,010,533 10,052,385 |
| Celgene Corp. v. Cipla Ltd., 19-14731 (D.N.J.) | July 3, 2019 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,465,800 7,855,217 7,968,569 8,530,498 8,648,095 9,101,621 9,101,622 7,189,740 8,404,717 9,056,120 |
| AstraZeneca LP v. HEC Pharm Co., Ltd., 19-14737 (D.N.J.) | July 3, 2019 | Hon. Claire C. Cecchi | Brilinta® (ticagrelor tablets) | RE46,276 7,265,124 |
| Leo Pharma A/S v. Teva Pharms. USA, Inc., 19-1282 (D. Del.) | July 9, 2019 | Hon. Colm F. Connolly | Finacea® (azelaic acid foam) | 10,322,085 |
| Boehringer Ingelheim Pharms. Inc. v. Zydus Pharms. (USA) Inc., 19-1295 (D. Del.) | July 11, 2019 | Hon. Colm F. Connolly | Glyxambi® (empagliflozin / linagliptin tablets) | 7,579,449 7,713,938 8,551,957 9,949,998 10,258,637 |
| Celgene Corp. v. Dr. Reddy’s Labs., Ltd., 19-15343 (D.N.J.) | July 12, 2019 | Hon. Esther Salas | Pomalyst® (pomalidomide capsules) | 8,198,262 8,673,939 8,735,428 8,828,427 9,993,467 |
| Actelion Pharms. Ltd. v. Aurobindo Pharma USA Inc., 19-15437 (D.N.J.) | July 16, 2019 | Hon. Freda L. Wolfson | Opsumit® (macitentan tablets) | 7,094,781 |
| Cubist Pharms. LLC v. Amneal Pharms. LLC, 19-15439 (D.N.J.) | July 16, 2019 | Hon. Brian R. Martinotti | Cubicin RF® (daptomycin for injection) | 9,138,456 |
| Teijin Ltd. v. Sunshine Lake Pharma Co., Ltd., 19-15448 (D.N.J.) | July 16, 2019 | Hon. Michael A. Shipp | Uloric® (febuxostat tablets) | 7,361,676 8,372,872 9,107,912 |
| Celgene Corp. v. Hetero Labs Ltd., 19-15449 (D.N.J.) | July 16, 2019 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,189,740 7,968,569 8,404,717 8,530,498 8,648,095 9,056,120 9,101,621 9,101,622 |
| Ajanta Pharma Ltd. v. Pfizer Inc., 19-6607 (S.D.N.Y.) | July 16, 2019 | Hon. Jesse M. Furman | Chantix® (varenicline tablets) | 6,890,927 7,265,119 |
| UCB, Inc. v. Mylan Technologies, Inc., 19-0128 (D. Vt.) | July 16, 2019 | Hon. John M. Conroy | Neupro® (rotigotine transdermal system) | 10,130,589 10,350,174 |
| Eisai Co., Ltd. v. Lupin Ltd., 19-1336 (D. Del.) | July 17, 2019 | Hon. Leonard P. Stark | Banzel® (rufinamide oral suspension) | 6,740,669 |
| Alkermes Pharma Ireland Ltd. v. Luye Pharma Group Ltd., 19-1340 (D. Del.) | July 17, 2019 | Hon. Leonard P. Stark | Risperdal Consta® (extended-release risperidone for injection) | 6,667,061 |
| Mitsubishi Tanabe Pharma Corp. v. MSN Labs. Private Ltd., 19-15616 (D.N.J.) | July 19, 2019 | Hon. Peter G. Sheridan | Invokamet XR® (canagliflozin / metformin HCl extended-release tablets) | 7,943,582 8,513,202 |
| Braintree Labs., Inc. v. Hetero Labs Ltd., 19-15676 (D.N.J.) | July 22, 2019 | Hon. Michael A. Shipp | Suprep® (sodium sulfate / potassium sulfate / magnesium sulfate oral lavage solution) | 6,946,149 |
| Corcept Therapeutics, Inc. v. Sun Pharma Global FZE, 19-15678 (D.N.J.) | July 22, 2019 | Hon. Susan D. Wigenton | Korlym® (mifepristone tablets) | 8,921,348 10,195,214 9,829,495 |
| AstraZeneca LP v. Dr. Reddy’s Labs., Ltd., 19-15739 (D.N.J.) | July 23, 2019 | Hon. Claire C. Cecchi | Brilinta® (ticagrelor tablets) | RE46,276 |
| Bayer Intellectual Property Gmbh v. Sunshine Lake Pharma Co., Ltd., 19-1448 (D. Del.) | Aug. 1, 2019 | Hon. Timothy Belcher Dyk | Xarelto® (rivaroxaban tablets) | 9,539,218 |
| Vifor (Int’l) AG v. Sandoz Inc., 19-16305 (D.N.J.) | Aug. 2, 2019 | Hon. Freda L. Wolfson | Injectafer® (ferric carboxymaltose for injection) | 7,612,109 7,754,702 8,895,612 9,376,505 |
| Janssen Pharms., Inc. v. Mylan Labs. Ltd., 19-16484 (D.N.J.) | Aug. 8, 2019 | Hon. Claire C. Cecchi | Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) | 9,439,906 |
| Abraxis Bioscience, LLC v. Sun Pharma Advanced Research Co., Ltd., 19-16495 (D.N.J.) | Aug. 8, 2019 | Hon. Stanley R. Chesler | Abraxane® (paclitaxel protein-bound particles for injectable suspension) | 7,758,891 7,820,788 7,923,536 8,034,375 8,138,229 8,268,348 8,314,156 8,853,260 9,101,543 9,393,318 9,511,046 9,597,409 |
| Janssen Pharms., Inc. v. Mylan Labs. Ltd., 19-1488 (D. Del.) | Aug. 9, 2019 | Hon. Colm F. Connolly | Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) | 9,439,906 |
| Par Pharm., Inc. v. American Regent, Inc., 19-1490 (D. Del.) | Aug. 9, 2019 | Hon. Colm F. Connolly | Vasostrict® (vasopressin for injection) | 9,375,478 9,687,526 9,744,209 9,750,785 |
| Boehringer Ingelheim Pharms. Inc. v. Aizant Drug Research Solutions Prv. Ltd., 19-1492 (D. Del.) | Aug. 9, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) | 10,258,637 |
| Boehringer Ingelheim Pharms. Inc. v. Alkem Labs. Ltd., 19-1493 (D. Del.) | Aug. 9, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) | 10,258,637 |
| Boehringer Ingelheim Pharms. Inc. v. Cipla Ltd., 19-1494 (D. Del.) | Aug. 9, 2019 | Hon. Colm F. Connolly | Synjardy® XR (empagliflozin / metformin extended-release tablets) | 10,258,637 |
| Boehringer Ingelheim Pharms. Inc. v. Dr. Reddy’s Labs., Ltd., 19-1495 (D. Del.) | Aug. 9, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) | 10,258,637 |
| Boehringer Ingelheim Pharms. Inc. v. Invagen Pharms., Inc., 19-1496 (D. Del.) | Aug. 9, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) | 10,258,637 |
| Boehringer Ingelheim Pharms. Inc. v. Lupin Ltd., 19-1497 (D. Del.) | Aug. 9, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) | 10,258,637 |
| Boehringer Ingelheim Pharms. Inc. v. Mankind Pharma Ltd., 19-1498 (D. Del.) | Aug. 9, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) | 10,258,637 |
| Boehringer Ingelheim Pharms. Inc. v. Prinston Pharm. Inc., 19-1499 (D. Del.) | Aug. 9, 2019 | Hon. Colm F. Connolly | Glyxambi® (empagliflozin / linagliptin tablets) | 10,258,637 |
| Boehringer Ingelheim Pharms. Inc. v. Sun Pharm. Indus. Ltd., 19-1500 (D. Del.) | Aug. 9, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) | 10,258,637 |
| Boehringer Ingelheim Pharms. Inc. v. Zydus Pharms. (USA) Inc., 19-1501 (D. Del.) | Aug. 9, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) Synjardy® (empagliflozin / metformin tablets) | 10,258,637 |
| Janssen Pharms., Inc. v. Mylan Labs. Ltd., 19-0153 (N.D.W.V.) | Aug. 9, 2019 | Hon. Thomas S. Kleeh | Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) | 9,439,906 |
| Novo Nordisk Inc. v. Mylan Institutional LLC, 19-1551 (D. Del.) | Aug. 20, 2019 | Hon. Colm F. Connolly | Victoza® (liraglutide recombinant solution for injection) | 6,268,343 7,762,994 8,114,833 8,579,869 8,846,618 9,265,893 RE41,956 |
| Novo Nordisk Inc. v. Mylan Institutional LLC, 19-0164 (N.D.W.V.) | Aug. 22, 2019 | Hon. Thomas S. Kleeh | Victoza® (liraglutide recombinant solution for injection) | 6,268,343 7,762,994 8,114,833 8,579,869 8,846,618 9,265,893 RE41,956 |
| Currax Pharms. LLC v. Zydus Pharms. (USA) Inc., 19-1569 (D. Del.) | Aug. 23, 2019 | Hon. Richard G. Andrews | Silenor® (doxepin HCl tablets) | 8,513,299 9,107,898 9,486,437 9,532,971 9,861,607 9,907,780 10,238,620 |
| Assertio Therapeutics Inc. v. Alkem Labs. Ltd., 19-17170 (D.N.J.) | Aug. 23, 2019 | Hon. Claire C. Cecchi | Nucynta® ER (tapentadol HCl extended-release tablets) | 8,309,060 |
| Boehringer Ingelheim Pharms. Inc. v. Annora Pharma Private Ltd., 19-1594 (D. Del.) | Aug. 28, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) | 10,258,637 |
| Boehringer Ingelheim Pharms. Inc. v. Laurus Labs Ltd., 19-1596 (D. Del.) | Aug. 28, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) | 10,258,637 |
| Bial – Portela & CA. S.A. v. Torent Pharms. Ltd., 19-1673 (D. Del.) | Sept. 6, 2019 | Hon. Colm F. Connolly | Aptiom® (eslicarbazepine acetate tablets) | 9,750,747 |
| Allergan USA, Inc. v. Aurobindo Pharma Ltd., 19-1674 (D. Del.) | Sept. 6, 2019 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 7,741,356 7,786,158 8,344,011 8,609,709 8,772,325 9,205,076 9,700,542 10,213,415 |
| Amgen Inc. v. The ACME Labs. Ltd., 19-1702 (D. Del.) | Sept. 11, 2019 | Hon. Mitchell S. Goldberg | Sensipar® (cinacalcet HCl tablets) | 9,375,405 |
| Allergan USA, Inc. v. Aurobindo Pharma Ltd., 19-1727 (D. Del.) | Sept. 13, 2019 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 8,691,860 9,115,091 9,364,489 9,675,587 9,789,125 10,188,632 |
| Genzyme Corp. v. Aizant Drug Research Solutions Private Ltd., 19-1734 (D. Del.) | Sept. 16, 2019 | Hon. Colm F. Connolly | Cerdelga® (eliglustat tablets) | 6,916,802 7,253,185 7,615,573 |
| Boehringer Ingelheim Pharms. Inc. v. Macleods Pharms. Ltd., 19-1772 (D. Del.) | Sept. 20, 2019 | Hon. Colm F. Connolly | Tradjenta® (linagliptin tablets) | 8,673,927 8,853,156 9,173,859 |
| Horizon Medicines LLC v. Ajanta Pharma Ltd., 19-1814 (D. Del.) | Sept. 27, 2019 | Hon. Richard G. Andrews | Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets) | 9,345,695 8,852,636 8,858,996 9,161,920 9,198,888 9,707,181 |
| Horizon Medicines LLC v. Ajanta Pharma Ltd., 19-18555 (D.N.J.) | Sept. 30, 2019 | Hon. Brian R. Martinotti | Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets) | 9,345,695 8,852,636 8,858,996 9,161,920 9,198,888 9,707,181 |
| Chiesi USA Inc. v. MSN Pharms. Inc., 19-18564 (D.N.J.) | Sept. 30, 2019 | Hon. Madeline Cox Arleo | Kengreal® (cangrelor for injection) | 8,680,052 9,295,687 9,427,448 9,439,921 9,700,575 9,925,265 10,039,780 |
| Chiesi USA Inc. v. Gland Pharma Ltd., 19-18565 (D.N.J.) | Sept. 30, 2019 | Hon. Madeline Cox Arleo | Kengreal® (cangrelor for injection) | 9,295,687 |
| Salix Pharms., Ltd. v. Sandoz Inc., 19-18566 (D.N.J.) | Sept. 30, 2019 | Hon. Michael A. Shipp | Xifaxan® (rifaximin tablets) | 7,045,620 7,612,199 7,902,206 7,906,542 7,915,275 8,158,644 8,158,781 8,193,196 8,309,569 8,518,949 8,741,904 8,835,452 8,853,231 9,271,968 |
GENERICally Speaking Fall 2019
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