Federal district court cases that are filed pursuant to the Hatch-Waxman Act
This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings before the Patent Trial and Appeal Board concerning Orange Book-listed patents.
| Case Name | Date Filed | Judge | Drug | Patent No(s). |
|---|---|---|---|---|
| Exeltis USA, Inc. v. Lupin Ltd., 22-0434 (D. Del.) | Apr. 1, 2022 | Honorable Richard G. Andrews | Slynd® (drospirenone tablets) | 9,603,860 10,179,140 10,603,281 10,849,857 10,987,364 11,123,299 |
| Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 22-0439 (D. Del.) | Apr. 1, 2022 | Honorable MaryEllen Noreika | Ingrezza® (valbenazine capsules) | 10,065,952 10,844,058 10,851,103 10,851,104 10,857,137 10,857,148 10,874,648 10,906,902 10,906,903 10,912,771 10,919,892 10,940,141 10,952,997 10,993,941 11,026,931 11,026,939 11,040,029 |
| Novartis Pharms. Corp. v. Zydus Pharms. (USA) Inc., 22-0440 (D. Del.) | Apr. 1, 2022 | Honorable Richard G. Andrews | Entresto® (sacubitril / valsartan tablets) | 11,058,667 |
| Azurity Pharms., Inc. v. CoreRx, Inc., 22- 0784 (M.D. Fla.) | Apr. 1, 2022 | Honorable Steven D. Merryday | Epaned® (enalapril maleate oral solution) | 11,040,023 11,141,405 |
| Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 22-1882 (D.N.J.) | Apr. 1, 2022 | Honorable Christine P. O'Hearn | Ingrezza® (valbenazine capsules) | 10,065,952 10,844,058 10,851,103 10,851,104 10,857,137 10,857,148 10,874,648 10,906,902 10,906,903 10,912,771 10,919,892 10,940,141 10,952,997 10,993,941 11,026,931 11,026,939 11,040,029 |
| Merck Sharp & Dohme Corp. v. Mankind Pharma Ltd., 22-0444 (D. Del.) | Apr. 4, 2022 | Honorable Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) | 7,326,708 |
| Celgene Corp. v. MSN Labs. Private Ltd., 22- 1993 (D.N.J.) | Apr. 6, 2022 | Honorable Esther Salas | Pomalyst® (pomalidomide capsules) | 8,198,262 8,673,939 8,735,428 8,828,427 9,993,467 10,555,939 |
| Evoke Pharma, Inc. v. Teva Pharms., Inc., 22- 2019 (D.N.J.) | Apr. 7, 2022 | Honorable Renee Marie Bumb | Gimoti® (metoclopramide nasal spray) | 8334281 11,020,361 |
| Otsuka Pharm. Co., Ltd. v. Mylan Labs. Ltd., 22-0464 (D. Del.) | Apr. 8, 2022 | Honorable Colm F. Connolly | Abilify Maintena® (aripiprazole extended-release injection) | 7,807,680 8,030,313 8,722,679 8,399,469 8,338,427 10,525,057 10,980,803 11,154,553 |
| Otsuka Pharm. Co., Ltd. v. Mylan Labs. Ltd., 22-0032 (N.D.W.V.) | Apr. 8, 2022 | Honorable Thomas S. Kleeh | Abilify Maintena® (aripiprazole extended-release injection) | 7,807,680 8,030,313 8,722,679 8,399,469 8,338,427 10,525,057 10,980,803 11,154,553 |
| Bayer Intellectual Property GmbH v. Changzhou Pharm. Factory, 22-2089 (D.N.J.) | Apr. 11, 2022 | Honorable Kevin McNulty | Xarelto® (rivaroxaban tablets) | 9,539,218 |
| Avadel CNS Pharms., LLC v. Jazz Pharms., Inc., 22-0487 (D. Del.) | Apr. 14, 2022 | Honorable Maryellen Noreika | Xyrem® (sodium oxybate oral solution) | 10,758,488 10,813,885 10,959,956 10,966,931 11,077,079 11,147,782 |
| Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Inc., 22-0498 (D. Del.) | Apr. 19, 2022 | Honorable Richard G. Andrews | Entresto® (sacubitril / valsartan tablets) | 11,058,667 |
| Arbor Pharms., LLC v. Amneal Pharms., LLC, 22-2323 (D.N.J.) | Apr. 21, 2022 | Honorable Karen W. Williams | Nymalize® (nimodipine oral solution) | 7,070,581 8,517,997 10,342,787 10,576,070 11,207,306 |
| Otsuka Pharm. Co., Ltd. v. Teva Pharms. Inc., 22-0513 (D. Del.) | Apr. 22, 2022 | Honorable Richard G. Andrews | Jynarque® (tolvaptan tablets) | 8501730 10,905,694 |
| BioMarin Pharm. Inc. v. Aurobindo Pharms. Ltd., 22-2345 (D.N.J.) | Apr., 22, 2022 | Honorable Michael A. Shipp | Kuvan® (sapropterin dihydrochloride tablets) | 7,566,462 7,566,714 7,612,073 7,727,987 8,003,126 8,067,416 RE43,797 8,318,745 9,433,624 |
| Astellas US LLC v. GE Healthcare Inc., 22-0523 (D. Del.) | Apr. 25, 2022 | Honorable Colm F. Connolly | Lexiscan® (regadenoson intravenous solution) | 8106183 RE47,301 8,524,883 |
| AstraZeneca AB v. Mylan Pharms. Inc., 22-0035 (N.D.W.V.) | Apr. 26, 2022 | Honorable Gina M. Groh | Symbicort® (budesonide / formoterol fumarate dehydrate inhalation aerosol) | 11,311,558 |
| Alcon Inc. v. Somerset Therapeutics, LLC, 22- 0543 (D. Del) | Apr. 27, 2022 | Vacant Judgeship (2022) | Pataday® Once- Daily (olopatadine HCl ophthalmic solution) | 8,791,154 9,533,053 |
| Journey Medical Corp. v. Padagis Israel Pharms. Ltd., 22-0587 (D. Del.) | May 2, 2022 | Honorable Colm F. Connolly | Zilxi® (minocycline topical foam) | 8,865,139 8,945,516 8,992,896 9,675,700 10,213,512 10,265,404 10,322,186 10,946,101 |
| Otsuka Pharm. Co., Ltd. v. Sandoz Inc., 22- 0591 (D. Del) | May 2, 2022 | Honorable Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 8,618,109 9,839,637 |
| Gilead Sciences, Inc. v. Lupin Ltd., 22-0615 (D. Del.) | May 9, 2022 | Honorable MaryEllen Noreika | Biktarvy® (bictegravir sodium / tenofovir alafenamide fumarate / emtricitabine tablets) |
9,708,342 10,385,067 10,548,846 |
| Bristol-Myers Squibb Co. v. Nanocopoeia, LLC, 22-1283 (D. Minn) | May 10, 2022 | Honorable Katherine M. Mendenez | Sprycel® (dasatinib tablets) | 7,491,725 8,680,103 |
| Abraxis BioScience, LLC v. Jiangsu Hengrui Pharms. Co., Ltd., 22-2745 (D.N.J.) | May 11, 2022 | Honorable Freda L. Wolfson | Abraxane® (paclitaxel protein- bound particles for injectable suspension) | 7,820,788 |
| Jazz Pharms. Ireland Ltd. v. Lupin Ltd., 22- 2773 (D.N.J.) | May 11, 2022 | Honorable Stanley R. Chesler | Xywav® (calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate oral solution) | 11,253,494 |
| Aragon Pharms., Inc. v. Lupin Ltd., 22-0637 (D. Del.) | May 13, 2022 | Hon. Colm F. Connolly | Erleada® (apalutamide tablets) | 9,481,663 |
| Neurocrine Biosciences, Inc. v. Lupin Ltd., 22-0639 (D. Del.) | May 13, 2022 | Honorable MaryEllen Noreika | Ingrezza® (valbenazine tosylate capsules) | 8,039,627 8,357,697 10,065,952 10,844,058 10,851,103 10,851,104 10,857,137 10,857,148 10,874,648 10,906,902 10,906,903 10,912,771 10,919,892 10,940,141 10,952,997 10,993,941 11,026,931 11,026,939 11,040,029 |
| Horizon Medicines LLC v. Apotex Inc., 22- 0640 (D. Del.) | May 13, 2022 | Honorable Christopher J. Burke | Pennsaid® (diclofenac sodium topical solution) | 9,066,913 |
| Par Pharm., Inc. v. Cipla Ltd., 22-2814 (D.N.J.) | May 13, 2022 | Honorable Madeline C. Arleo | Vasostrict® (vasopressin injection) | 9,919,026 9,925,233 9,962,422 9,968,649 9,974,827 9,981,006 10,010,575 |
| Aragon Pharms., Inc. v. Lupin Ltd., 22-2825 (D.N.J.) | May 13, 2022 | Hon. Julien Xavier Neals | Erleada® (apalutamide tablets) | 9,481,663 |
| Celgene Corp. v. Oncogen Pharma (Malaysia) Sdn. Bhd., 22-2952 (D.N.J.) | May 20, 2022 | Honorable 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 |
| Aragon Pharms., Inc. v. Zydus Worldwide DMCC, 22-2964 (D.N.J.) | May 20, 2022 | Honorable Julien Xavier Neals | Erleada® (apalutamide tablets) | 9,481,663 9,884,054 10,052,314 10,702,508 10,849,888 |
| Momenta Pharms., Inc. v. Mylan Pharms., Inc., 22-0750 (W.D. Pa.) | May 20, 2022 | Honorable Robert J. Colville | Glatopa® (glatiramer acetate injection) | 8,859,489 9.395,374 |
| Aragon Pharms., Inc. v. Sandoz Inc., 22-0678 (D. Del.) | May 24, 2022 | Honorable Colm F. Connolly | Erleada® (apalutamide tablets) | 8,445,507 8,802,689 9,388,159 9,481,663 9,987,261 |
| Aragon Pharms., Inc. v. Sandoz Inc., 22-3044 (D.N.J.) | May 24, 2022 | Honorable Julien Xavier Neals | Erleada® (apalutamide tablets) | 8,445,507 8,802,689 9,388,159 9,481,663 9,987,261 |
| Aragon Pharms., Inc. v. Eugia Pharma Specialities Ltd. (A.K.A. Eugia Pharma Specialties Ltd.), 22- 0688 (D. Del.) | May 26, 2022 | Honorable Colm F. Connolly | Erleada® (apalutamide tablets) | 8,445,507 8,802,689 9,388,159 9,481,663 9,987,261 |
| Aragon Pharms., Inc. v. Eugia Pharma Specialities Ltd. (A.K.A. Eugia Pharma Specialties Ltd.), 22- 0688 (D. Del.) | May 26, 2022 | Honorable Julien Xavier Neals | Erleada® (apalutamide tablets) | 8,445,507 8,802,689 9,388,159 9,481,663 9,987,261 |
| Aragon Pharms., Inc. v. Hetero Labs Ltd. Unit V, 22-0696 (D. Del.) | May 27, 2022 | Honorable Colm F. Connolly | Erleada® (apalutamide tablets) | 8,445,507 9,481,663 9,884,054 10,052,314 10,702,508 10,849,888 |
| Eagle Pharms., Inc. v. Accord Healthcare Inc., 22-0704 (D. Del.) | May 27, 2022 | Honorable Colm F. Connolly | Belrapzo® (bendamustine HCl injection) | 8,609,707 9,265,831 9,572,796 9,572,797 10,010,533 11,103,483 |
| Aragon Pharms., Inc. v. Hetero Labs Ltd. Unit V, 22-3212 (D.N.J.) | May 27, 2022 | Hon. Julien Xavier Neals | Erleada® (apalutamide tablets) | 8,445,507 9,481,663 9,884,054 10,052,314 10,702,508 10,849,888 |
| Ingenus Pharms., LLC v. Nexus Pharms., Inc., 22-2868 (N.D. Ill.) | June 1, 2022 | Honorable Mary M. Rowland | cyclophosphamide injection | 10,993,952 |
| Galderma Labs., L.P. v. Apotex Inc., 22-0724 (D. Del.) | June 2, 2022 | Honorable Stephanos Bibas | Oracea® (doxycycline capsules) | 7,749,532 8,206,740 |
| Novartis Pharms. Corp. v. Biocon Pharma Ltd., 22-0726 (D. Del.) | June 2, 2022 | Honorable Richard G. Andrews | Entresto® (sacubitril / valsartan tablets) | 11,058,667 |
| Vertex Pharms. Inc. v. Aurobindo Pharma Ltd., 22 - 0728 (D. Del.) | June 2, 2022 | Honorable Richard G. Andrews | Kalydeco® (ivacaftor tablets) | 10,646,481 |
| Avion Pharms., LLC v. Lupin Ltd., 22-0729 (D. Del.) | June 2, 2022 | Honorable Colm F. Connolly | Balcoltra® (levonorgestrel ethinyl estradiol / ferrous bisglycinate tablets) | 7,838,042 |
| Novartis Pharms. Corp. v. Accord Healthcare Inc., 22- 0744 (D. Del.) | June 6, 2022 | Honorable MaryEllen Noreika | Rydapt® (midostaurin capsules) | 7,973,031 |
| Pfizer Inc. v. MSN Labs. Private Ltd., 22- 0746 (D. Del.) | June 6, 2022 | Honorable Colm F. Connolly | Xeljanz® (tofacitinib oral solution) | RE41,783 |
| Bristol-Myers Squibb Co. v. Biocon Pharma Ltd., 22-3505 (D.N.J.) | June 6, 2022 | Honorable Noel L. Hillman | Sprycel® (dasatinib tablets) | 7491725 8,680,103 |
| Novartis Pharms. Corp. v. Accord Healthcare Inc., 22- 0431 (M.D.N.C.) | June 6, 2022 | Honorable William L. Osteen, Jr. | Rydapt® (midostaurin capsules) | 7,973,031 |
| Eisai Co., Ltd. v. Aurobindo Pharma Ltd., 22-3610 (D.N.J.) | June 8, 2022 | Honorable Christine P. O'Hearn | Banzel® (rufinamide tablets) | 6,740,669 |
| Mylan Pharms. Inc. v. Bausch Health Ireland Ltd., IPR2022-01102 (PTAB) | June 10, 2022 | N/A | Trulance® (plecanatide tablets) | 9,610,321 |
| Mylan Pharms. Inc. v. Bausch Health Ireland Ltd., IPR2022-01103 (PTAB) | June 10, 2022 | N/A | Trulance® (plecanatide tablets) | 9,616,097 |
| Mylan Pharms. Inc. v. Bausch Health Ireland Ltd., IPR2022-01104 (PTAB) | June 10, 2022 | N/A | Trulance® (plecanatide tablets) | 9,919,024 |
| Mylan Pharms. Inc. v. Bausch Health Ireland Ltd., IPR2022-01105 (PTAB) | June 10, 2022 | N/A | Trulance® (plecanatide tablets) | 9,925,231 |
| Bristol-Myers Squibb Co. v. Accord Healthcare Inc., 22- 3743 (D.N.J.) | June 13, 2022 | Honorable Renee Marie Bumb | Sprycel® (dasatinib tablets) | 7,491,725 8,680,103 |
| Celgene Corp. v. Qilu Pharm. Co., Ltd., 22- 3753 (D.N.J.) | June 13, 2022 | Honorable Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,465,800 7,855,217 |
| Amgen Inc. v. Apotex Inc., 22-3827 (D.N.J.) | June 14, 2022 | Honorable Michael A. Shipp | Otezla® (apremilast tablets) | 7,427,638 9,872,854 10,092,541 |
| Astellas Pharma Inc. v. Sawai Pharm. Co., Ltd., 22-0818 (D. Del.) | June 17, 2022 | Honorable Joseph F. Bataillon | Myrbetriq® (mirabegron extended-release tablets) | 6,346,532 7,342,117 7,982,049 8,835,474 RE44,872 10,842,780 |
| Scilex Pharms. Inc. v. Aveva Drug Delivery Systems, Inc., 22-61192 (S.D. Fla.) | June 22, 2022 | Honorable William P. Dimitrouleas | ZTlido® (lidocaine topical system) | 9,283,174 9,925,264 9,931,403 |
| Gilead Sciences, Inc. v. Natco Pharma Ltd., 22- 0852 (D. Del.) | June 23, 2022 | Honorable Richard G. Andrews | Zydelig® (idelalisib tablets) | RE44,599 RE44,638 8,865,730 9,469,643 10,730,879 |
| Chemo Research SL v. Encube Ethicals Private, Ltd., 22-0854 (D. Del.) | June 24, 2022 | Honorable Colm F. Connolly | Nuvessa® (metronidazole vaginal gel) | 7,893,097 8,658,678 8,877,792 8,946,276 9,198,858 10,238,634 10,596,155 |
| Novo Nordisk Inc. v. Orbicular Pharm. Technologies Pvt. Ltd., 22-0856 (D. Del.) | June 24, 2022 | Honorable Colm F. Connolly | Saxenda® (liraglutide recombinant solution injection) | 7,762,994 8,114,833 8,579,869 8,684,969 8,920,383 9,108,002 9,132,239 9,457,154 9,616,180 9,687,611 9,775,953 9,861,757 10,220,155 10,357,616 10,376,652 11,097,063 11,311,679 RE46,363 |
| Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., 22-4248 (D.N.J.) |
June 24, 2022 | Honorable Madeline Cox Arleo | Arazlo® (tazarotene lotion) | 11,311,482 |
| Bristol-Myers Squibb Co. v. Xspray Pharma AB, 22-4328 (D.N.J.) | June 29, 2022 | Hon. Renee Marie Bumb | Sprycel® (dasatinib tablets) | 7,491,725 8,680,103 |
| Bausch & Lomb Inc. v. Gland Pharma Ltd., 22-4345 (D.N.J.) | June 30, 2022 | Honorable Michael A. Shipp | Vyzulta® (latanoprostene bunod ophthalmic solution) | 7,273,946 7,629,345 7,910,767 8,058,467 |
