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New ANDA Cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Fourth Quarter
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). |
|---|---|---|---|---|
| Novo Nordisk Inc. v. ScinoPharm Taiwan Ltd., 23-20935 (D.N.J.) | Oct. 5, 2023 | Hon. Esther Salas | Victoza® (liraglutide recombinant solution injection) | 8,114,833 9,265,893 |
| Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of New York, LLC, 23-20964 (D.N.J.) | Oct. 6, 2023 | Hon. Claire C. Cecchi | ProAir® HFA (albuterol sulfate inhalation aerosol) | 8,132,712 9,463,289 9,808,587 10,561,808 10,695,512 11,395,889 |
| Micro Labs Ltd. v. Hikma Pharms. USA Inc., 23-1138 (D. Del.) | Oct. 11, 2023 | Hon. Colm F. Connolly | Mitigare® (colchicine capsules) | 8,927,607 9,399,036 9,555,029 9,675,613 |
| Fresenius Kabi USA, LLC v. Caplin Steriles Ltd., 23-1144 (D. Del.) | Oct. 12, 2023 | Hon. Maryellen Noreika | Naropin® (ropivacaine HCl injection) | 7,828,787 7,857,802 |
| Bristol-Myers Squibb Co. v. Zydus Pharms. (USA) Inc., 23-21098 (D.N.J.) | Oct. 12, 2023 | Hon. Renee Marie Bumb | Sprycel® (dasatinib tablets) | 7,491,725 8,680,103 |
| Bayer Healthcare LLC v. Padagis Israel Pharms. Ltd., 23-1148 (D. Del.) | Oct. 13, 2023 | Hon. William C. Bryson | Astepro® (azelastine HCl nasal spray) | 8,071,073 8,518,919 9,919,050 |
| Hikma Pharms. USA Inc. v. Cipla USA, Inc., 23-1157 (D. Del.) | Oct. 13, 2023 | Hon. Gregory B. Williams | Kloxxado® (naloxone HCl nasal spray) | 10,722,510 10,973,814 11,135,155 11,617,713 11,628,139 |
| Celgene Corp. v. Accord Healthcare, Inc., 23-21189 (D.N.J.) | Oct. 16, 2023 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,465,800 7,855,217 8,741,929 |
| Pfizer Inc. v. Aurobindo Pharma Ltd., 23-1182 (D. Del.) | Oct. 19, 2023 | Hon. Gregory B. Williams | Vyndaqel® (tafamidis meglumine capsules) | 7,214,696 |
| ZS Pharma, Inc. v. Alkem Labs. Ltd., 23-1187 (D. Del.) | Oct. 20, 2023 | Hon. Gregory B. Williams | Lokelma® (sodium zirconium cyclosilicate for oral suspension) | 11,738,044 |
| ZS Pharma, Inc. v. Ascent Pharms. Inc., 23-1188 (D. Del.) | Oct. 20, 2023 | Hon. Gregory B. Williams | Lokelma® (sodium zirconium cyclosilicate for oral suspension) | 11,738,044 |
| ZS Pharma, Inc. v. Lupin Ltd., 23-1189 (D. Del.) | Oct. 20, 2023 | Hon. Gregory B. Williams | Lokelma® (sodium zirconium cyclosilicate for oral suspension) | 11,738,044 |
| ZS Pharma, Inc. v. Macleods Pharms. Ltd., 23-1190 (D. Del.) | Oct. 20, 2023 | Hon. Gregory B. Williams | Lokelma® (sodium zirconium cyclosilicate for oral suspension) | 11,738,044 |
| ZS Pharma, Inc. v. Sandoz Inc., 23-1191 (D. Del.) | Oct. 20, 2023 | Hon. Gregory B. Williams | Lokelma® (sodium zirconium cyclosilicate for oral suspension) | 11,738,044 |
| Taiho Pharm. Co., Ltd. v. Eugia Pharma Specialties Ltd., 23-1193 (D. Del.) | Oct. 20, 2023 | Hon. Colm F. Connolly | Lonsurf® (trifluridine / tipiracil tablets) | 9,943,537 |
| Novo Nordisk Inc. v. Meitheal Pharms., Inc., 23-1195 (D. Del.) | Oct. 20, 2023 | Hon. Colm F. Connolly | Victoza® (liraglutide recombinant solution injection) | 8,114,833 9,265,893 |
| Bayer Pharma AG v. Cipla Ltd., 23-1196 (D. Del.) | Oct. 20, 2023 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Dr. Reddy’s Labs., Inc. v. Novo Nordisk A/S, IPR2024-00009 (PTAB) | Oct. 20, 2023 | N/A | Ozempic® (semaglutide subcutaneous solution) | 10,335,462 |
| Impact Biomedicines, Inc. v. Teva Pharms., Inc., 23-21385 (D.N.J.) | Oct. 23, 2023 | Hon. Michael E. Farbiarz | Inrebic® (fedratinib capsules) | 10,391,094 11,400,092 |
| AbbVie Inc. v. Sandoz, Inc., 23-1212 (D. Del.) | Oct. 25, 2023 | Hon. Richard G. Andrews | Orilissa® (elagolix sodium tablets) | 11,542,239 11,690,845 11,690,854 11,707,464 |
| Bayer Pharma AG v. Taro Pharm. Indus. Ltd., 23-1219 (D. Del.) | Oct. 26, 2023 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Orion Corp. v. Hetero USA Inc., 23-1221 (D. Del.) | Oct. 26, 2023 | Hon. Colm F. Connolly | Nubeqa® (darolutamide tablets) | 10,010,530 10,383,853 10,835,515 11,168,058 |
| Endo Par Innovation Co. v. Deva Holding A.S., 23-21684 (D.N.J.) | Oct. 31, 2023 | Hon. Christine P. O’Hearn | Adrenalin® (epinephrine injection) | 9,119,876 9,295,657 |
| Incyte Corp. v. Padagis Israel Pharms. Ltd., 23-21826 (D.N.J.) | Nov. 2, 2023 | Hon. Madeline Cox Arleo | Opzelura® (ruxolitinib cream) | 10,758,543 10,869,870 11,219,624 11,510,923 11,571,425 11,590,136 11,590,137 11,590,138 11,602,536 |
| Sun Pharm. Indus. Ltd. v. Novo Nordisk A/S, IPR2024-00107 (PTAB) | Nov. 2, 2023 | N/A | Ozempic® (semaglutide injection) | 10,335,462 |
| BeiGene USA, Inc. v. Pharmacyclics LLC, PGR2024-00009 (PTAB) | Nov. 2, 2023 | N/A | Imbruvica® (ibrutinib capsules) | 11,672,803 |
| Takeda Pharms. U.S.A., Inc. v. Scilex Pharms. Inc., 23-1264 (D. Del.) | Nov. 6, 2023 | Hon. Richard G. Andrews | Gloperba® (colchicine oral solution) | 7,619,004 7,820,681 7,964,648 8,093,297 8,097,655 8,440,722 |
| AbbVie Inc. v. Teva Pharms., Inc., 23-1268 (D. Del.) | Nov. 7, 2023 | Hon. Richard G. Andrews | Oriahnn® (elagolix sodium / estradiol / norethindrone acetate capsules) | 11,690,845 |
| Actelion Pharms. Ltd. v. Mylan Pharms. Inc., 23-0088 (N.D.W.V.) | Nov. 7, 2023 | Hon. Thomas S. Kleeh | Opsumit® (macitentan tablets) | 7,094,781 10,946,015 |
| Eli Lilly & Co. v. MSN Labs. Private Ltd., 23-1277 (D. Del.) | Nov. 8, 2023 | Hon. Colm F. Connolly | Olumiant® (baricitinib tablets) | 8,158,616 |
| Novo Nordisk Inc. v. Dr. Reddy’s Labs., Ltd., 23-22112 (D.N.J.) | Nov. 8, 2023 | Hon. Esther Salas | Victoza® (liraglutide recombinant solution injection) | 8,114,833 9,265,893 |
| Harmony Biosciences, LLC v. Lupin Ltd., 23-1286 (D. Del.) | Nov. 9, 2023 | Hon. Maryellen Noreika | Wakix® (pitolisant HCl tablets) | 8,486,947 8,207,197 |
| Purdue Pharma L.P. v. Elite Labs., Inc., 23-22221 (D.N.J.) | Nov. 9, 2023 | Hon. Karen M. Williams | OxyContin® (oxycodone HCl extended-release tablets) | 9,763,933 9,770,416 9,492,389 9,492,391 9,492,392 9,492,393 9,775,808 11,304,908 11,304,909 9,073,933 9,522,919 10,407,434 9,775,811 9,763,886 11,298,322 |
| Pfizer Inc. v. Dexcel Pharma Technologies Ltd., 23-1304 (D. Del.) | Nov. 15, 2023 | Hon. Colm F. Connolly | Xeljanz® XR (tofacitinib citrate extended-release tablets) | RE41,783 |
| Catalyst Pharms., Inc. v. Inventia Healthcare Ltd., 23-22461 (D.N.J.) | Nov. 17, 2023 | Hon. Michael E. Farbiarz | Firdapse® (amifampridine tablets) | 10,626,088 10,793,893 11,060,128 11,268,128 11,274,331 11,274,332 |
| Catalyst Pharms., Inc. v. Inventia Healthcare Ltd., 23-1331 (D. Del.) | Nov. 20, 2023 | Hon. Jennifer Choe-Groves | Firdapse® (amifampridine tablets) | 10,626,088 10,793,893 11,060,128 11,268,128 11,274,331 11,274,332 |
| AbbVie Inc. v. Hetero USA, Inc., 23-1332 (D. Del.) | Nov. 20, 2023 | Hon. Maryellen Noreika | Rinvoq® (upadacitinib tablets) | RE47,221 8,962,629 9,951,080 10,981,923 11,186,584 11,661,425 11,680,069 11,718,627 11,198,697 9,963,459 10,344,036 10,202,393 10,519,164 10,730,883 10,981,924 10,597,400 11,535,624 10,995,095 10,550,126 11,535,625 11,535,626 11,365,198 11,512,092 11,524,964 11,607,411 11,564,922 11,767,326 11,773,105 11,773,106 11,780,847 11,780,848 11,787,815 11,795,175 9,879,018 |
| Harmony Biosciences, LLC v. AET Pharma US, Inc., 23-1340 (D. Del.) | Nov. 21, 2023 | Hon. Maryellen Noreika | Wakix® (pitolisant HCl tablets) | 8,486,947 8,207,197 8,354,430 |
| Bayer Pharma AG v. Aurobindo Pharma Ltd., 23-1372 (D. Del.) | Dec. 1, 2023 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| AstraZeneca AB v. Sun Pharm. Industries Ltd., 23-1381 (D. Del.) | Dec. 4, 2023 | Hon. Richard G. Andrews | Xigduo XR® (dapagliflozin / metformin HCl extended-release tablets) | 6,515,117 |
| AstraZeneca AB v. Sun Pharm. Industries Ltd., 23-1382 (D. Del.) | Dec. 4, 2023 | Hon. Richard G. Andrews | Qtern® (dapagliflozin / saxagliptin HCl tablets) | 6,515,117 |
| AstraZeneca AB v. Sun Pharm. Industries Ltd., 23-1383 (D. Del.) | Dec. 4, 2023 | Hon. Richard G. Andrews | Farxiga® (dapagliflozin tablets) | 6,515,117 |
| Bausch & Lomb, Inc. v. Slayback Pharma LLC, 23-22906 (D.N.J.) | Dec. 5, 2023 | Hon. Robert Kirsch | Lumify® (brimonidine tartrate ophthalmic solution) | 11,833,245 |
| Merck Sharp & Dohme LLC v. Hetero USA Inc., 23-22954 (D.N.J.) | Dec. 7, 2023 | Hon. Claire C. Cecchi | Isentress HD® (raltegravir tablets) | 7,754,731 8,771,733 9,649,311 10,772,888 |
| Par Pharm., Inc. v. Long Grove Pharms., LLC, 23-1412 (D. Del.) | Dec. 8, 2023 | Hon. Gregory B. Williams | Vasostrict® (vasopressin injection) | 9,993,520 11,207,372 |
| MSN Labs. Private Ltd. v. Bioprojet Société Civile De Recherche, 23-1675 (E.D. Va.) | Dec. 8, 2023 | Hon. Claude M. Hilton | Wakix® (pitolisant HCl tablets) | 8,486,947 8,207,197 8,354,430 |
| Harmony Biosciences, LLC v. MSN Pharms. Inc., 23-1420 (D. Del.) | Dec. 11, 2023 | Hon. Maryellen Noreika | Wakix® (pitolisant HCl tablets) | 8,486,947 8,207,197 8,354,430 |
| Jazz Pharms. Research UK Ltd. v. Apotex Inc., 23-23141 (D.N.J.) | Dec. 15, 2023 | Hon. Michael E. Farbiarz | Epidiolex® (cannabidiol oral solution) | 11,701,330 11,766,411 |
| Axsome Therapeutics, Inc. v. Teva Pharms., Inc., 23-23142 (D.N.J.) | Dec. 15, 2023 | Hon. Michael E. Farbiarz | Auvelity® (dextromethorphan hydrobromide / bupropion HCl extended-release tablets) | 11,717,518 11,730,706 11,752,144 |
| Novartis Pharms. Corp. v. Novugen Oncology Sdn. Bhd., 23-1449 (D. Del.) | Dec. 20, 2023 | Hon. Gregory B. Williams | Mekinist® (trametinib dimethyl sulfoxide tablets) | 7,378,423 8,580,304 9,155,706 9,271,941 9,399,021 |
| Axsome Malta Ltd. v. Unichem Labs. Ltd., 23-23255 (D.N.J.) | Dec. 20, 2023 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 11,753,368 11,771,666 11,771,667 11,779,554 11,793,776 |
| Bayer Intellectual Property GmbH v. Umedica Labs. Pvt. Ltd., 23-1456 (D. Del.) | Dec. 21, 2023 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 9,539,218 10,828,310 |
| AstraZeneca AB v. ScieGen Pharms., Inc., 23-1457 (D. Del.) | Dec. 21, 2023 | Hon. Richard G. Andrews | Brilinta® (ticagrelor tablets) | 10,300,065 |
| Novo Nordisk Inc. v. Sun Pharm. Indus. Ltd., 23-1459 (D. Del.) | Dec. 21, 2023 | Hon. Colm F. Connolly | Wegovy® (semaglutide injection) | 8,129,343 9,764,003 10,888,605 11,318,191 11,752,198 |
| Azurity Pharms., Inc. v. Aurobindo Pharma Ltd., 23-23273 (D.N.J.) | Dec. 21, 2023 | Hon. Jamel K. Semper | Firvanq® (vancomycin HCl oral solution) | 10,493,028 10,688,046 10,959,946 10,959,947 10,959,948 10,959,949 11,638,692 |
| Gilead Sciences, Inc. v. Cipla Ltd., 23-1480 (D. Del.) | Dec. 29, 2023 | Hon. Maryellen Noreika | Biktarvy® (bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate tablets) | 9,708,342 10,385,067 |
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