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New ANDA Cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
First 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). |
|---|---|---|---|---|
| Taiho Pharm. Co., Ltd. v. MSN Labs. Private Ltd., 23-0008 (D. Del.) | Jan. 3, 2023 | Hon. Colm F. Connolly | Lonsurf® (tipiracil HCl / trifluridine tablets) | 10,960,004 |
| GW Research Ltd. v. Teva Pharms., Inc., 23-0018 (D.N.J.) | Jan. 3, 2023 | Hon. Susan D. Wigenton | Epidiolex® (cannabidiol) | 9,949,937 9,956,183 9,956,184 9,956,185 9,956,186 10,092,525 10,111,840 10,137,095 10,603,288 10,709,671 10,709,673 10,709,674 10,849,860 10,918,608 10,966,939 11,065,209 11,096,905 11,154,516 11,160,795 11,207,292 11,311,498 11,357,741 11,400,055 11,406,623 11,446,258 |
| Chiesi USA Inc. v. Eugia Pharma Specialties Ltd., 23-0022 (D.N.J.) | Jan. 4, 2023 | Hon. Karen M. Williams | Kengreal® (cangrelor injection) | 8,680,052 9,295,687 9,427,448 9,439,921 9,700,575 9,925,265 10,039,780 |
| IBSA Institut Biochimique SA v. Accord Healthcare, Inc., 23-0054 (D.N.J.) | Jan. 5, 2023 | Hon. Julien Xavier Neals | Tirosint®-SOL (levothyroxine sodium oral solution) | 10,537,538 11,096,913 |
| Cosette Pharms., Inc. v. Azurity Pharms., Inc., 23-0018 (D. Del.) | Jan. 6, 2023 | Hon. Mitchell S. Goldberg | Firvanq® Kit (vancomycin HCl oral solution) | 10,493,028 10,688,046 10,959,946 10,959,947 10,959,948 10,959,949 |
| Azurity Pharms., Inc. v. Alkem Labs Ltd., 23-0079 (D.N.J.) | Jan. 6, 2023 | Hon. Karen M. Williams | Eprontia® (topiramate oral solution) | 11,433,046 |
| Merck Sharp & Dohme LLC v. Lupin Ltd., 23-0094 (D.N.J.) | Jan. 9, 2023 | Hon. Claire C. Cecchi | Isentress HD® (raltegravir tablets) | 7,754,731 9,649,311 10,772,888 |
| Astellas Pharma Inc. v. Qilu Pharma, Inc., 23-0022 (D. Del.) | Jan. 10, 2023 | Hon. Joseph F. Bataillon | Myrbetriq® (mirabegron extended-release tablets) | 10,842,780 |
| Actelion Pharms. Ltd. v. Sun Pharm. Indus. Ltd., 23-0116 (D.N.J.) | Jan. 10, 2023 | Hon. Stanley R. Chesler | Opsumit® (macitentan tablets) | 7,094,781 10,946,015 |
| Fennec Pharms. Inc. v. Cipla Ltd., 23-0123 (D.N.J.) | Jan. 10, 2023 | Hon. Madeline Cox Arleo | Pedmark® (sodium thiosulfate injection) | 11,291,728 11,510,984 10,596,190 |
| Novartis Pharms. Corp. v. HEC Pharm Co., Ltd., 23-0026 (D. Del.) | Jan. 11, 2023 | Hon. Gregory B. Williams | Gilenya® (fingolimod capsules) | 10,543,179 |
| Astellas Pharma Inc. v. Qilu Pharma, Inc., 23-0125 (E.D. Pa.) | Jan. 11, 2023 | Hon. Kelley Brisbon Hodge | Myrbetriq® (mirabegron extended-release tablets) | 10,842,780 |
| Amgen Inc. v. MSN Labs. Private Ltd., 23-0031 (D. Del.) | Jan. 12, 2023 | Hon. Mayellen Noreika | Parsabiv® (etelcalcetide injection) | 11,162,500 |
| Bausch Health Ireland Ltd. v. Aurobindo Pharma Ltd., 23-0170 (D.N.J.) | Jan. 12, 2023 | Hon. Stanley R. Chesler | Trulance® (plecanatide tablets) | 7,041,786 9,610,321 9,616,097 9,919,024 9,925,231 10,011,637 11,142,549 11,319,346 |
| Merck KGaA v. Aurobindo Pharma USA, Inc., 23-0039 (D. Del.) | Jan. 13, 2023 | Hon. Gregory B. Williams | Mavenclad® (cladribine tablets) | 7,713,947 8,377,903 10,849,919 |
| Boehringer Ingelheim Pharms. Inc. v. Hetero USA Inc., 23-0048 (D. Del.) | Jan. 13, 2023 | Hon. Colm F. Connolly | Tradjenta® (linagliptin tablets) | 9,486,526 10,034,877 |
| GW Research Ltd. v. Invagen Pharms., Inc., 23-0256 (E.D.N.Y.) | Jan. 13, 2023 | Hon. Diane Gujarati | Epidiolex® (cannabidiol) | 9,949,937 9,956,183 9,956,184 9,956,185 9,956,186 10,092,525 10,111,840 10,137,095 10,603,288 10,709,671 10,709,673 10,709,674 10,849,860 10,966,939 11,096,905 11,154,516 11,207,292 11,311,498 11,357,741 11,446,258 |
| Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. Graviti Pharms. Private Ltd., 23-0068 (D. Del.) | Jan. 20, 2023 | Hon. Colm F. Connolly | Desyrel® (trazodone HCl tablets) | 8,133,893 |
| Jazz Pharms. Ireland Ltd. v. Lupin Ltd., 23-0329 (D.N.J.) | Jan. 20, 2023 | Hon. Stanley R. Chesler | Xywav® (calcium, magnesium, potassium, and sodium oxybates oral solution) | 11,426,373 11,554,102 |
| Novo Nordisk Inc. v. Viatris Inc., 23-0101 (D. Del.) | Jan. 27, 2023 | Hon. Colm F. Connolly | Wegovy® (semaglutide injection) | 8,129,343 8,536,122 9,764,003 10,888,605 11,318,191 |
| Novo Nordisk Inc. v. Viatris Inc., 23-0013 (N.D.W.V.) | Jan. 27, 2023 | Hon. Thomas S. Kleeh | Wegovy® (semaglutide injection) | 8,129,343 8,536,122 9,764,003 10,888,605 11,318,191 |
| AbbVie Inc. v. Teva Pharms., Inc., 23-0133 (D. Del.) | Feb. 3, 2023 | Hon. Richard G. Andrews | Oriahnn® (elagolix sodium / estradiol / norethindrone acetate oral capsules) | 10,881,659 11,045,470 |
| Sandoz Inc. v. Acerta Pharma B.V., IPR2023-00478 (PTAB) | Feb. 3, 2023 | N/A | Calquence® (acalabrutinib capsules) Calquence® (acalabrutinib maleate tablets) | 10,272,083 |
| Exela Pharma Sciences, LLC v. Nivagen Pharms., Inc., 23-0137 (D. Del.) | Feb. 6, 2023 | Hon. Maryellen Noreika | Elcys® (cysteine HCl injection) | 10,583,155 11,510,941 |
| Abraxis Bioscience, LLC v. Hainan Shuangcheng Pharms. Co., Ltd., 23-0750 (D.N.J.) | Feb. 8, 2023 | Hon. Karen M. Williams | Abraxane® (paclitaxel injection) | 7,758,891 7,820,788 7,923,536 8,034,375 8,138,229 8,268,348 8,314,156 9,101,543 9,393,318 9,511,046 9,597,409 |
| Actelion Pharms. US, Inc. v. Lupin Ltd., 23-0150 (D. Del.) | Feb. 9, 2023 | Hon. Gregory B. Williams | Uptravi® (selexipag for injection) | 8,791,122 9,284,280 |
| Bausch & Lomb Inc. v. Lupin Ltd., 23-0790 (D.N.J.) | Feb. 10, 2023 | Hon. Julien Xavier Neals | Lotemax® SM (loteprednol etabonate ophthalmic gel) | 10,596,107 |
| AstraZeneca Pharms. LP v. Natco Pharma Ltd., 23-0796 (D.N.J.) | Feb. 10, 2023 | Hon. Zahid N. Quraishi | Lynparza® (olaparib tablets) | 7,449,464 8,475,842 8,859,562 |
| Hopewell Pharma Ventures, Inc. v. Ares Trading SA, IPR2023-00482 (PTAB) | Feb. 10, 2023 | N/A | Mavenclad® (cladribine tablets) | 10,849,919 |
| Apotex Inc. v. Celgene Corp., IPR2023-00512 (PTAB) | Feb. 10, 2023 | N/A | Onureg® (azacitidine tablets) | 8,846,628 |
| Shionogi & Co., Ltd. v. Norwich Pharms., Inc., 23-0161 (D. Del.) | Feb. 13, 2023 | Hon. Maryellen Noreika | Xofluza® (baloxavir marboxil tablets) | 8,927,710 8,987,441 9,815,835 10,392,406 10,633,397 10,759,814 11,261,198 11,306,106 |
| Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 23-0926 (D.N.J.) | Feb. 16, 2023 | Hon. Karen M. Williams | Yupelri® (revefenacin inhalation solution) | 8,541,451 9,765,028 10,550,081 11,008,289 11,484,531 |
| Novo Nordisk Inc. v. Orbicular Pharm. Technologies Pvt. Ltd., 23-0179 (D. Del.) | Feb. 17, 2023 | Hon. Colm F. Connolly | Victoza® (liraglutide recombinant solution injection) | 8,114,833 9,265,893 |
| Theravance Biopharma R&D IP, LLC v. Lupin Inc., 23-0187 (D. Del.) | Feb. 17, 2023 | Hon. Gregory B. Williams | Yupelri® (revefenacin inhalation solution) | 8,541,451 9,765,028 10,550,081 11,008,289 11,484,531 |
| Theravance Biopharma R&D IP, LLC v. Accord Healthcare, Inc., 23-0157 (M.D.N.C.) | Feb. 17, 2023 | Hon. William L. Osteen, Jr. | Yupelri® (revefenacin inhalation solution) | 8,541,451 9,765,028 10,550,081 11,008,289 11,484,531 |
| Astellas Pharma Inc. v. Humanwell Puracap Pharms. (Wuhan) Co., Ltd., 23-1020 (D.N.J.) | Feb. 21, 2023 | Hon. John Michael Vazquez | Xtandi® (enzalutamide capsules) | 7,709,517 8,183,274 |
| Alcon Inc. v. Alembic Pharms. Ltd., 23-0194 (D. Del.) | Feb. 22, 2023 | Hon. Gregory B. Williams | Pataday® (olopatadine HCl ophthalmic solution) | 8,791,154 9,533,053 |
| Upsher-Smith Labs., LLC v. Xiamen LP Pharm. Co., Ltd., 23-0199 (D. Del.) | Feb. 23, 2023 | Hon. Gregory B. Williams | Qudexy® XR (topiramate extended-release capsules) | 8,889,190 9,101,545 9,555,005 10,363,224 |
| Par Pharm., Inc. v. Cipla Ltd., 23-1150 (D.N.J.) | Feb. 28, 2023 | Hon. Madeline Cox 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 9,925,234 |
| Catalyst Pharms., Inc. v. Teva Pharms., Inc., 23-1190 (D.N.J.) | Mar. 1, 2023 | Hon. Madeline Cox Arleo | 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. Annora Pharma Private Ltd., 23-1194 (D.N.J.) | Mar. 1, 2023 | Hon. Madeline Cox Arleo | 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. Lupin Ltd., 23-1197 (D.N.J.) | Mar. 1, 2023 | Hon. Madeline Cox Arleo | 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. Lupin Ltd., 23-0229 (D. Del.) | Mar. 2, 2023 | Hon. Maryellen Noreika | Firdapse® (amifampridine tablets) | 10,626,088 10,793,893 11,060,128 11,268,128 11,274,331 11,274,332 |
| Hikma Pharms. USA Inc. v. Annora Pharma Private Ltd., 23-0231 (D. Del.) | Mar. 2, 2023 | Hon. Richard G. Andrews | Mitigare® (colchicine capsules) | 8,927,607 9,399,036 9,555,029 9,675,613 9,789,108 |
| Astellas Pharma Inc. v. Sandoz, Inc., 23-1214 (D.N.J.) | Mar. 2, 2023 | Hon. Esther Salas | Xospata® (gilteritinib tablets) | 10,786,500 |
| Nexus Pharms., Inc. v. Somerset Pharma, LLC, 23-1248 (D.N.J.) | Mar. 3, 2023 | Hon. Zahid N. Quraishi | Emerphed® (ephedrine sulfate injection) | 11,478,436 11,426,369 |
| UCB, Inc. v. Annora Pharma Private Ltd., 23-0243 (D. Del.) | Mar. 6, 2023 | Hon. Colm F. Connolly | Briviact® (brivaracetam oral solution) | 6,911,461 |
| Adverio Pharma GmbH v. Alembic Pharms. Ltd., 23-1285 (D.N.J.) | Mar. 7, 2023 | Hon. Susan D. Wigenton | Adempas® (riociguat tablets) | 7,173,037 |
| Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 23-0266 (D. Del.) | Mar. 10, 2023 | Hon. Maryellen Noreika | Ingrezza® (valbenazine capsules) | 8,039,627 8,357,697 |
| Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 23-1369 (D.N.J.) | Mar. 10, 2023 | Hon. Claire C. Cecchi | Ingrezza® (valbenazine capsules) | 8,039,627 8,357,697 |
| Allergan, Inc. v. Mankind Pharma Ltd., 23-0272 (D. Del.) | Mar. 13, 2023 | Hon. Richard G. Andrews | Lumigan® (bimatoprost ophthalmic solution) | 7,851,504 |
| Exelixis, Inc. v. Cipla Ltd., 23-0287 (D. Del.) | Mar. 16, 2023 | Hon. Richard G. Andrews | Cabometyx® (cabozantinib tablets) | 8,877,776 11,091,439 11,091,440 11,098,015 11,298,349 |
| Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00722 (PTAB) | Mar. 16, 2023 | N/A | Ozempic® (semaglutide injection) Rybelsus® (semaglutide tablets) Wegovy® (semaglutide injection) | 8,536,122 |
| Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724 (PTAB) | Mar. 16, 2023 | N/A | Ozempic® (semaglutide injection) | 10,335,462 |
| Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. Sun Pharm. Indus., Inc., 23-0295 (D. Del.) | Mar. 17, 2023 | Hon. Richard G. Andrews | Desyrel® (trazodone HCl tablets) | 8,133,893 |
| Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc., 23-1505 (D.N.J.) | Mar. 17, 2023 | Hon. Renee Marie Bumb | Korlym® (mifepristone tablets) | 10,842,800 10,842,801 |
| Alcon Inc. v. Gland Pharma Ltd., 23-0303 (D. Del.) | Mar. 20, 2023 | Hon. Gregory B. Williams | Pataday® Once-Daily Relief 0.7% (olopatadine HCl ophthalmic solution) | 8,791,154 9,533,053 |
| Jazz Pharms. Ireland Ltd. v. Teva Pharms., Inc., 23-1617 (D.N.J.) | Mar. 21, 2023 | Hon. Stanley R. Chesler | Xywav® (calcium, magnesium, potassium, and sodium oxybates oral solution) | 8,591,922 8,772,306 8,901,173 9,050,302 9,132,107 9,486,426 10,195,168 10,213,400 10,675,258 10,864,181 11,253,494 11,426,373 11,554,102 |
| Bayer Intellectual Property GmbH v. Apotex Inc., 23-0327 (D. Del.) | Mar. 24, 2023 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 9,539,218 |
| Keryx Biopharmaceuticals, Inc. v. Zydus Worldwide DMCC, 23-0331 (D. Del.) | Mar. 24, 2023 | Hon. Gregory B. Williams | Auryxia® (ferric citrate tablets) | 7,767,851 8,093,423 8,299,298 8,338,642 8,609,896 8,754,257 8,754,258 8,846,976 8,901,349 9,050,316 9,387,191 9,328,133 9,757,416 10,300,039 |
| Bayer Intellectual Property GmbH v. Biocon Pharma Ltd., 23-0334 (D. Del.) | Mar. 24, 2023 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 9,539,218 10,828,310 |
| Bayer Intellectual Property GmbH v. Sciegen Pharms., Inc., 23-0335 (D. Del.) | Mar. 24, 2023 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 9,539,218 10,828,310 |
| Aragon Pharms., Inc. v. Zydus Worldwide DMCC, 23-1685 (D.N.J.) | Mar. 24, 2023 | Hon. Evelyn Padin | Erleada® (apalutamide tablets) | 8,445,507 8,802,689 9,388,159 9,987,261 RE49,353 |
| Axsome Therapeutics, Inc. v. Teva Pharms., Inc., 23-1695 (D.N.J.) | Mar. 24, 2023 | Hon. Susan D. Wigenton | Auvelity® (dextromethorphan hydrobromide / bupropion HCl extended-release tablets) | 10,780,064 10,925,842 10,940,124 10,966,942 |
| Par Pharm., Inc. v. Baxter Healthcare Corp., 23-0358 (D. Del.) | Mar. 29, 2023 | Hon. Gregory B. Williams | Vasostrict® (vasopressin injection) | 9,993,520 11,135,265 11,207,372 |
| AbbVie Inc. v. Teva Pharm., Inc., 23-0362 (D. Del.) | Mar. 30, 2023 | Hon. Richard G. Andrews | Oriahnn® (elagolix sodium / estradiol / norethindrone acetate oral capsules copackaged with elagolix sodium oral capsules) | 11,542,239 |
| Azurity Pharms., Inc. v. Accord Healthcare, Inc., 23-0373 (D. Del.) | Mar. 31, 2023 | Hon. Colm F. Connolly | Thyquidity® (levothyroxine sodium oral solution) | 9,050,307 |
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