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). |
| Janssen Products, L.P. v. Ever Valinject GmbH, 24-9441 (N.D. Ill.) | Oct. 3, 2024 | Hon. Thomas M. Durkin | Yondelis® (trabectedin injection) | 8,895,557 7,420,051 |
| American Regent, Inc. v. Accord Healthcare, Inc., 24-9600 (D.N.J.) | Oct. 3, 2024 | Hon. Brian R. Martinotti | Tralement® (trace elements injection) Multrys® (trace elements injection) |
11,786,548 11,975,022 11,998,565 |
| Galderma Labs., L.P. v. Macleods Pharms. Ltd., 24-1105 (D. Del.) | Oct. 4, 2024 | Hon. Stephanos Bibas | Oracea® (doxycycline capsules) | 7,749,532 8,206,740 |
| Pfizer Inc. v. Breckenridge Pharm., Inc., 24-1122 (D. Del.) | Oct. 9, 2024 | Hon. Colm F. Connolly | Xeljanz® (tofacitinib tablets) | RE41,783 |
| Teva Branded Pharm. Products R&D, Inc. v. Cipla USA, Inc., 24-9691 (D.N.J.) | Oct. 9, 2024 | Hon. Stanley R. Chesler | Qvar RediHaler® (beclomethasone dipropionate inhalation aerosol) | 8,132,712 8,931,476 10,022,509 10,022,510 10,086,156 10,561,808 10,695,512 10,792,447 11,395,888 11,395,889 11,559,637 11,583,643 11,793,953 11,865,247 11,896,759 11,957,832 |
| Novo Nordisk Inc. v. Apotex Inc., 24-9729 (D.N.J.) | Oct. 10, 2024 | Hon. Renee Marie Bumb | Rybelsus® (semaglutide tablets) | 8,129,343 9,278,123 10,086,047 10,278,923 10,933,120 10,960,052 11,382,957 11,759,501 11,759,502 11,759,503 |
| Astellas Pharma Inc. v. Zydus Pharms. (USA) Inc., 24-9748 (D.N.J.) | Oct. 11, 2024 | Hon. Michael A. Shipp | Xtandi® (enzalutamide tablets) | 11,839,689 |
| Advanced Accelerator Applications USA, Inc. v. Curium US LLC, 24-1161 (D. Del.) | Oct. 17, 2024 | Hon. Maryellen Noreika | Lutathera® (lutetium Lu 177 dotatate injection) | 10,596,276 10,596,278 11,904,027 |
| Actelion Pharms. US, Inc. v. Lannett Co., Inc., 24-1162 (D. Del.) | Oct. 17 | Hon. Gregory B. Williams | Uptravi® (selexipag tablets) | 8,791,122 9,284,280 |
| Advanced Accelerator Applications USA, Inc. v. Curium US LLC, 24-1392 (E.D. Mo.) | Oct. 18, 2024 | Hon. John M. Bodenhausen | Lutathera® (lutetium Lu 177 dotatate injection) | 10,596,276 10,596,278 11,904,027 |
| Allergan Holdings Unlimited Co. v. MSN Labs. Private Ltd., 24-1187 (D. Del.) | Oct. 23, 2024 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 12,097,187 |
| Allergan Holdings Unlimited Co. v. Sun Pharm. Indus. Ltd., 24-1188 (D. Del.) | Oct. 23, 2024 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 12,097,187 |
| ViiV Healthcare Co. v. Hetero USA Inc., 24-1189 (D. Del.) | Oct. 23, 2024 | Hon. Mitchell S. Goldberg | Tivicay® (dolutegravir tablets) | 9,242,986 |
| Sandoz Inc. v. Boehringer Ingelheim Pharms. Inc., 24-1192 (D. Del.) | Oct. 24, 2024 | Hon. Maryellen Noreika | Ofev® (nintedanib capsules) | 9,907,756 10,105,323 |
| Novartis Pharms. Corp. v. MSN Pharms. Inc., 24-1193 (D. Del.) | Oct. 24, 2024 | Hon. Jennifer L. Hall | Kisqali® (ribociclib tablets) | 8,962,630 9,416,136 |
| Cipla Ltd. v. Gilead Sciences, Inc., IPR2025-00033 (PTAB) | Oct. 28, 2024 | N/A | Biktarvy® (bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate tablets) | 11,744,802 |
| Exelixis, Inc. v. Sun Pharm. Indus. Ltd., 24-1208 (D. Del.) | Oct. 30, 2024 | Hon. Richard G. Andrews | Cabometyx® (cabozantinib (S)-malate tablets) | 8,877,776 11,091,439 11,091,440 11,098,015 |
| Salix Pharms, Inc. v. Cipla USA, Inc., 24-10213 (D.N.J.) | Nov. 1, 2024 | Hon. Edward S. Kiel | Xifaxan® (rifaximin tablets) | 11,564,912 11,779,571 8,193,196 |
| Intra-Cellular Therapies, Inc. v. Alkem Labs. Ltd., 24-10234 (D.N.J.) | Nov. 1, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 12,090,155 12,122,792 12,128,043 |
| Intra-Cellular Therapies, Inc. v. Aurobindo Pharma Ltd., 24-10235 (D.N.J.) | Nov. 1, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 12,090,155 12,122,792 12,128,043 |
| Intra-Cellular Therapies, Inc. v. Dr. Reddy’s Labs. Inc., 24-10236 (D.N.J.) | Nov. 1, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 12,090,155 12,122,792 12,128,043 |
| Intra-Cellular Therapies, Inc. v. Hetero USA, Inc., 24-10237 (D.N.J.) | Nov. 1, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 12,090,155 12,122,792 12,128,043 |
| Intra-Cellular Therapies, Inc. v. MSN Labs. Private Ltd., 24-10238 (D.N.J.) | Nov. 1, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 12,090,155 12,122,792 12,128,043 |
| Intra-Cellular Therapies, Inc. v. Sandoz Inc., 24-10239 (D.N.J.) | Nov. 1, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 12,090,155 12,122,792 12,128,043 |
| Intra-Cellular Therapies, Inc. v. Zydus Pharms. (USA) Inc., 24-10240 (D.N.J.) | Nov. 1, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 12,090,155 12,122,792 12,128,043 |
| Salix Pharms, Inc. v. Carnegie Pharms. LLC, 24-10356 (D.N.J.) | Nov. 7, 2024 | Hon. Edward S. Kiel | Xifaxan® (rifaximin tablets) | 11,564,912 11,779,571 8,193,196 |
| Pfizer Inc. v. Sandoz Inc., 24-1244 (D. Del.) | Nov. 12, 2024 | Hon Richard G. Andrews | Inlyta® (axitinib tablets) | 8,791,140 |
| AstraZeneca Pharms. LP v. Zydus Pharms. (USA) Inc., 24-10458 (D.N.J.) | Nov. 12, 2024 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) | 8,859,562 8,475,842 11,633,396 11,975,001 12,048,695 |
| AbbVie Inc. v. Hetero USA, Inc., 24-1254 (D. Del.) | Nov. 14, 2024 | Hon. Maryellen Noreika | Rinvoq® (Upadacitinib tablets) | 12,077,545 12,103,933 12,110,297 12,116,373 12,110,298 |
| Genentech, Inc. v. Natco Pharma Ltd., 24-10567 (D.N.J.) | Nov. 18, 2024 | Hon. Brian R. Martinotti | Evrysdi® (risdiplam oral solution) | 9,586,955 9,969,754 11,534,444 11,827,646 11,938,136 |
| Shionogi & Co., Ltd. v. Norwich Pharms., Inc., 24-1264 (D. Del.) | Nov. 18, 2024 | Hon. Maryellen Noreika | Xofluza® (baloxavir marboxil tablets) | 12,064,438 |
| Azurity Pharms., Inc. v. Exelixis, Inc., IPR2025-00210 (PTAB) | Nov. 18, 2024 | N/A | Cometriq® (cabozanitinib S-malate capsules) Cabometyx® (cabozanitinib S-malate tablets) | 11,298,349 |
| SK Biopharmaceuticals Co., Ltd. v. MSN Pharms. Inc., 24-1270 (D. Del.) | Nov. 19, 2024 | Hon. Jennifer L. Hall | Xcopri® (cenobamate tablets) | 11,654,133 |
| Axsome Malta Ltd. v. Alkem Labs. Ltd., 24-10617 (D.N.J.) | Nov. 20, 2024 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 12,090,126 |
| Axsome Malta Ltd. v. Hetero USA Inc., 24-10618 (D.N.J.) | Nov. 20, 2024 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 12,090,126 |
| Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 24-10619 (D.N.J.) | Nov. 20, 2024 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 12,090,126 |
| Axsome Malta Ltd. v. Hikma Pharms. USA Inc., 24-10620 (D.N.J.) | Nov. 20, 2024 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 12,090,126 12,102,609 |
| AstraZeneca Pharms. LP v. Natco Pharma Ltd., 24-10624 (D.N.J.) | Nov. 20, 2024 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) | 12,144,810 |
| AstraZeneca Pharms. LP v. Sandoz Inc., 24-10627 (D.N.J.) | Nov. 20, 2024 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) | 12,144,810 |
| AstraZeneca Pharms. LP v. Cipla Ltd., 24-10628 (D.N.J.) | Nov. 20, 2024 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) | 12,144,810 |
| AstraZeneca Pharms. LP v. Zydus Pharms. (USA) Inc., 24-10629 (D.N.J.) | Nov. 20, 2024 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) | 12,144,810 |
| American Regent, Inc. v. MSN Labs. Private Ltd., 24-10674 (D.N.J.) | Nov. 22, 2024 | Hon. Georgette Castner | Injectafer® (ferric carboxymaltose injection) | 7,754,702 |
| Astellas Pharma Inc. v. Cipla Ltd., 24-1287 (D. Del.) | Nov. 22, 2024 | Hon. Gregory B. Williams | Cresemba® (isavuconazonium sulfate injection) | 6,812,238 |
| Cassiopea S.p.A. v. Aurobindo Pharma Ltd., 24-10734 (D.N.J.) | Nov. 25, 2024 | Hon. Jamel K. Semper | Winlevi® (clascoterone topical cream) | 8,785,427 9,433,628 9,486,458 10,159,682 11,207,332 11,938,141 |
| Eli Lilly & Co. v. Qilu Pharm. Co., Ltd., 24-10802 (D.N.J.) | Nov. 27, 2024 | Hon. Evelyn Padin | Reyvow® (lasmiditan tablets) | 12,071,423 |
| Merck Sharp & Dohme LLC v. Zydus Pharms. (USA) Inc., 24-10820 (D.N.J.) | Nov. 27, 2024 | Hon. Karen M. Williams | Prevymis® (letermovir tablets) | RE 46,791 |
| Pacira Pharms., Inc. v. Fresenius Kabi USA, LLC, 24-12416 (N.D. Ill.) | Dec. 3, 2024 | Hon. Steven C. Seeger | Exparel® (bupivacaine liposome injectable suspension) | 12,156,940 |
| Axsome Therapeutics, Inc. v. Teva Pharms., Inc., 24-10938 (D.N.J.) | Dec. 5, 2024 | Hon. Michael E. Farbiarz | Auvelity® (dextromethorphan hydrobromide / bupropion HCl extended-release tablets) | 12,146,889 |
| Amicus Therapeutics US, LLC v. Aurobindo Pharma Ltd., 24-1331 (D. Del.) | Dec. 6, 2024 | Hon. Colm F. Connolly | Galafold® (migalastat capsules) | 12,042,489 12,042,490 12,109,205 |
| Astellas Pharma Inc. v. Cipla Ltd., 24-1333 (D. Del.) | Dec. 6, 2024 | Hon. Gregory B. Williams | Cresemba® (isavuconazonium sulfate capsules) | 6,812,238 10,206,879 10,603,280 |
| Vanda Pharms. Inc. v. Apotex Inc., 24-1344 (D. Del.) | Dec. 9, 2024 | Hon. Jennifer L. Hall | Hetlioz® (tasimelteon capsules) | 11,918,556 |
| Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., 24-1345 (D. Del.) | Dec. 9, 2024 | Hon. Jennifer L. Hall | Hetlioz® (tasimelteon capsules) | 11,918,556 |
| eVenus Pharm. Labs., Inc. v. Pacira Pharms., Inc., 24-11014 (D.N.J.) | Dec. 10, 2024 | Hon. Madeline Cox Arleo | Exparel® (bupivacaine liposome injectable suspension) | 12,156,940 |
| Aytu BioPharma, Inc. v. Granules Pharms. Inc., 24-1356 (D. Del.) | Dec. 11, 2024 | Hon. Colm F. Connolly | Adzenys XR-ODT® (amphetamine extended-release orally disintegrating tablets) | 8,709,491 8,840,924 9,017,731 9,265,737 |
| Orbicular Pharm. Technologies Pvt. Ltd. v. Shire-NPS Pharms., Inc., 24-1366 (D. Del.) | Dec. 13, 2024 | Hon. Jennifer L. Hall | Gattex® (teduglutide injection) | 7,847,061 9,060,992 |
| Novartis Pharms. Corp. v. Natco Pharma Ltd., 24-1367 (D. Del.) | Dec. 13, 2024 | Hon. Jennifer L. Hall | Kisqali® (ribociclib tablets) | 9,868,739 |
| American Regent, Inc. v. Accord Healthcare Inc., 24-11108 (D.N.J.) | Dec. 13, 2024 | Hon. Brian R. Martinotti | Selenious Acid | 12,150,957 |
| American Regent, Inc. v. Aspiro Pharma Ltd., 24-11109 (D.N.J.) | Dec. 13, 2024 | Hon. Brian R. Martinotti | Selenious Acid | 12,150,957 |
| American Regent, Inc. v. Cipla USA, Inc., 24-11112 (D.N.J.) | Dec. 13, 2024 | Hon. Brian R. Martinotti | Selenious Acid | 12,150,957 |
| American Regent, Inc. v. Dr. Reddy’s Labs., Inc., 24-11114 (D.N.J.) | Dec. 13, 2024 | Hon. Brian R. Martinotti | Selenious Acid | 12,150,957 |
| American Regent, Inc. v. Gland Pharma Ltd., 24-11116 (D.N.J.) | Dec. 13, 2024 | Hon. Brian R. Martinotti | Selenious Acid | 12,150,957 |
| American Regent, Inc. v. Hikma Pharms. USA Inc., 24-11118 (D.N.J.) | Dec. 13, 2024 | Hon. Brian R. Martinotti | Selenious Acid | 12,150,957 |
| American Regent, Inc. v. RK Pharma, Inc., 24-11122 (D.N.J.) | Dec. 13, 2024 | Hon. Brian R. Martinotti | Selenious Acid | 12,150,957 |
| American Regent, Inc. v. Somerset Therapeutics, LLC, 24-11124 (D.N.J.) | Dec. 13, 2024 | Hon. Brian R. Martinotti | Selenious Acid | 12,150,957 |
| American Regent, Inc. v. Sun Pharm. Indus. Ltd., 24-11126 (D.N.J.) | Dec. 13, 2024 | Hon. Brian R. Martinotti | Selenious Acid | 12,150,957 |
| American Regent, Inc. v. Xiromed, LLC, 24-11130 (D.N.J.) | Dec. 13, 2024 | Hon. Brian R. Martinotti | Selenious Acid | 12,150,957 |
| American Regent, Inc. v. Zydus Pharms. (USA) Inc., 24-11133 (D.N.J.) | Dec. 13, 2024 | Hon. Brian R. Martinotti | Selenious Acid | 12,150,957 |
| American Regent, Inc. v. Somerset Therapeutics, LLC, 24-11138 (D.N.J.) | Dec. 13, 2024 | Hon. Brian R. Martinotti | Selenious Acid | 11,998,565 12,150,957 |
| TherapeuticsMD, Inc. v. Teva Pharms. USA, Inc., 24-11161 (D.N.J.) | Dec. 13, 2024 | Hon. Brian R. Martinotti | Imvexxy® (estradiol vaginal inserts) | 11,065,197 11,116,717 11,123,283 11,241,445 11,246,875 11,266,661 11,304,959 11,351,182 11,497,709 |
| Bausch Health Ireland Ltd. v. MSN Labs. Private Ltd., 24-11179 (D.N.J.) | Dec. 16, 2024 | Hon. Stanley R. Chesler | Trulance® (plecanatide tablets) | 12,146,003 |
| Avadel CNS Pharms., LLC v. Jazz Pharms., Inc., 24-1384 (D. Del.) | Dec. 17, 2024 | Hon. Gregory B. Williams | Lumryz® (sodium oxybate extended-release oral suspension) | 12,167,991 |
| Novartis Pharms. Corp. v. Umedica Labs. Pvt. Ltd., 24-1408 (D. Del.) | Dec. 23, 2024 | Hon. Richard G. Andrews | Entresto® (sacubitril / valsartan tablets) | 8,101,659 8,877,938 9,388,134 9,517,226 9,937,143 11,058,667 11,096,918 11,135,192 |
| UCB, Inc. v. Aurobindo Pharma Ltd., 24-11428 (D.N.J.) | Dec. 23, 2024 | Hon. Claire C. Cecchi | Neupro® (rotigotine transdermal system) | 8,246,979 9,925,150 10,130,589 10,350,174 |
| Athena Bioscience, LLC v. Novitium Pharma LLC, 24-1421 (D. Del.) | Dec. 27, 2024 | Hon. Gregory B. Williams | Qdolo® (tramadol HCl oral solution) | 11,103,452 11,752,103 |
| Mitsubishi Tanabe Pharma Corp. v. Lupin Ltd., 24-1423 (D. Del.) | Dec. 30, 2024 | Hon. Jennifer L. Hall | Radicava ORS® (edaravone oral suspension) | 10,987,341 11,241,416 11,478,450 11,826,352 11,957,660 |
| Pfizer Inc. v. Alkem Labs. Ltd., 24-1427 (D. Del.) | Dec. 30, 2024 | Hon. Colm F. Connolly | Xeljanz® (tofacitinib tablets) | RE41,783 |
| American Regent, Inc. v. Amneal Pharms. of NY, LLC, 24-11503 (D.N.J.) | Dec. 30, 2024 | Hon. Brian R. Martinotti | Selenious Acid | 11,998,565 12,150,957 |
| Endo USA, Inc. v. Gland Pharma Ltd., 24-11529 (D.N.J.) | Dec. 31, 2024 | Hon. Zahid N. Quraishi | Vasostrict® (vasopressin injection) | 9,919,026 9,925,233 9,925,234 9,962,422 9,968,649 9,974,827 9,981,006 10,010,575 |
