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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). |
|---|---|---|---|---|
| Merck Sharp & Dohme LLC v. Prinston Pharm. Inc., 22-1300 (D. Del.) | Oct. 3, 2022 | Hon. Richard G. Andrews | Janumet® (metformin HCl / sitagliptin phosphate tablets) | 7,326,708 |
| Azurity Pharms., Inc. v. Novitium Pharma, LLC, 22-5860 (D.N.J.) | Oct. 3, 2022 | Hon. Esther Salas | Epaned® (enalapril maleate oral solution) | 11,040,023 11,141,405 |
| Galderma Labs., L.P. v. Alembic Pharms. Ltd., 22-1312 (D. Del.) | Oct. 5, 2022 | Hon. Stephanos Bibas | Oracea® (doxycycline capsules) | 7,749,532 8,206,740 |
| Array Biopharma Inc. v. Sandoz Inc., 22-1316 (D. Del.) | Oct. 6, 2022 | Hon. Gregory B. Williams | Mektovi® (binimetinib tablets) | 9,314,464 9,850,229 10,005,761 9,562,016 9,598,376 9,980,944 |
| Eisai R&D Management Co., Ltd. v. Dr. Reddy’s Labs., Inc., 22-5950 (D.N.J.) | Oct. 7, 2022 | Hon. Georgette Castner | Halaven® (eribulin mesylate injection) | RE 46,965 |
| Nexus Pharms., Inc. v. Nevakar, Inc., 22-6030 (D.N.J.) | Oct. 11, 2022 | Hon. Renee Marie Bumb | Emerphed® (ephedrine sulfate injection) | 11,464,752 |
| Merck Sharp & Dohme LLC v. Laurus Labs Ltd., 22-1348 (D. Del.) | Oct. 12, 2022 | Hon. Richard G. Andrews | Janumet® (metformin HCl / sitagliptin phosphate tablets) | 7,326,708 |
| MSN Labs. Pvt. Ltd. v. Bausch Health Ireland Ltd., IPR2023-00016 (PTAB) | Oct. 12, 2022 | N/A | Trulance® (plecanatide tablets) | 7,041,786 |
| Eli Lilly and Co. v. Dr. Reddy’s Labs., Ltd., 22-1354 (D. Del.) | Oct. 14, 2022 | Hon. Colm F. Connolly | Forteo® (teriparatide [rDNA origin] injection) | 7,517,334 |
| Twi Pharms. Inc. v. Merck Serono SA, IPR2023-00049 (PTAB) | Oct. 14, 2022 | N/A | Mavenclad® (cladribine tablets) | 7,713,947 |
| Twi Pharms. Inc. v. Merck Serono SA, IPR2023-00050 (PTAB) | Oct. 14, 2022 | N/A | Mavenclad® (cladribine tablets) | 8,377,903 |
| Dr. Reddy’s Labs., Inc. v. AbbVie, Inc., IPR2023-00052 (PTAB) | Oct. 14, 2022 | N/Z | Venclexta® (venetoclax tablets) | 11,110,087 |
| Merck KGaA v. Hopewell Pharma Ventures, Inc., 22-1365 (D. Del.) | Oct. 17, 2022 | Hon. Gregory B. Williams | Mavenclad® (cladribine tablets) | 7,713,947 8,377,903 10,849,919 |
| Otsuka Pharm. Co., Ltd. v. Mylan Labs. Ltd., 22-1367 (D. Del.) | Oct. 17, 2022 | Hon. Colm F. Connolly | Abilify Maintena® (aripiprazole extended-release injection) | 11,400,087 |
| Adverio Pharma GmbH v. Alembic Pharms. Ltd., 22-6104 (D.N.J.) | Oct. 17, 2022 | Hon. Esther Salas | Adempas® (riociguat tablets) | 10,662,188 11,203,593 |
| Takeda Pharms. America, Inc. v. Apotex, Inc., 22-6151 (D.N.J.) | Oct. 18, 2022 | Hon. Karen M. Williams | Iclusig® (ponatinib HCl tablets) | 11,384,086 |
| Acadia Pharms. Inc. v. Zydus Pharms. (USA) Inc., 22-1386 (D. Del.) | Oct. 21, 2022 | Hon. Gregory B. Williams | Nuplazid® (pimavanserin tartrate capsules) | 11,452,721 |
| Acadia Pharms. Inc. v. Aurobindo Pharma Ltd., 22-1387 (D. Del.) | Oct. 21, 2022 | Hon. Gregory B. Williams | Nuplazid® (pimavanserin tartrate capsules) | 11,452,721 |
| Acadia Pharms. Inc. v. MSN Labs. Private Ltd., 22-1388 (D. Del.) | Oct. 21, 2022 | Hon. Gregory B. Williams | Nuplazid® (pimavanserin tartrate capsules) | 11,452,721 |
| Fresenius Kabi USA, LLC v. Xiromed Pharma Espana, S.L., 22-6220 (D.N.J.) | Oct. 21, 2022 | Hon. Michael A. Shipp | levothyroxine sodium for injection | 9,006,289 9,168,238 9,168,239 |
| Astellas US LLC v. Baxter Healthcare Corp., 22-1390 (D. Del.) | Oct. 24, 2022 | Hon. Colm F. Connolly | Lexiscan® (regadenoson intravenous solution) | 8,106,183 RE 47,301 8,524,883 |
| Alcon Inc. v. Aurobindo Pharma Ltd., 22-1391 (D. Del.) | Oct. 24, 2022 | Hon. Gregory B. Williams | Pataday® (olopatadine HCl ophthalmic solution) | 8,791,154 9,533,053 |
| Novartis Pharms. Corp. v. Alembic Pharms. Ltd., 22-1395 (D. Del.) | Oct. 24, 2022 | Hon. Richard G. Andrews | Entresto® (sacubitril / valsartan tablets) | 11,096,918 |
| Gilead Sciences, Inc. v. Apotex Inc., 22-1399 (D. Del.) | Oct. 25, 2022 | Hon. Maryellen Noreika | Symtuza® (darunavir / cobicistat / emtricitabine / tenofovir alafenamide tablets) | 10,039,718 10,786,518 8,497,396 9,428,473 9,115,100 |
| Gilead Sciences, Inc. v. Apotex Inc., 22-1400 (D. Del.) | Oct. 25, 2022 | Hon. Maryellen Noreika | Symtuza® (darunavir / cobicistat / emtricitabine / tenofovir alafenamide tablets) | 8,754,065 9,296,769 |
| Servier Pharms. LLC v. Alembic Pharms. Ltd., 22-1420 (D. Del.) | Oct. 26, 2022 | Hon. Gregory B. Williams | Tibsovo® (ivosidenib tablets) | 9,968,595 10,449,184 10,799,490 10,980,788 |
| Alcon Inc. v. Padagis Israel Pharms. Ltd., 22-1422 (D. Del.) | Oct. 27, 2022 | Hon. Maryellen Noreika | Simbrinza® (brinzolamide / brimonidine tartrate ophthalmic suspension) | 9,044,484 9,421,265 |
| AbbVie Inc. v. Alkem Labs. Ltd., 22-1423 (D. Del.) | Oct. 27, 2022 | Hon. Richard G. Andrews | Orilissa® (elagolix sodium tablets) | 7,056,927 7,176,211 7,419,983 10,537,572 10,682,351 11,344,551 |
| Supernus Pharms., Inc. v. Ajanta Pharma Ltd., 22-1431 (D. Del.) | Oct. 28, 2022 | Hon. Gregory B. Williams | Oxtellar XR® (oxcarbazepine extended-release tablets) | 7,722,898 7,910,131 8,617,600 8,821,930 9,119,791 9,351,975 9,370,525 9,855,278 10,220,042 11,166,960 |
| Supernus Pharms, Inc. v. RiconPharma LLC, 22-6340 (D.N.J.) | Oct. 28, 2022 | Hon. Kevin McNulty | Oxtellar XR® (oxcarbazepine extended-release tablets) | 11,166,960 |
| Fresenius Kabi USA, LLC v. Accord Healthcare Inc., 22-6341 (D.N.J.) | Oct. 28, 2022 | Hon. Michael A. Shipp | levothyroxine sodium for injection | 9,006,289 9,168,238 9,168,239 |
| Pierre Febre Dermatologie v. Annora Pharma Private Ltd., 22-1442 (D. Del.) | Nov. 2, 2022 | Hon. Richard G. Andrews | Hemangeol® (propranolol HCl oral solution) | 8,338,489 8,987,262 |
| Actelion Pharms. US, Inc. v. Alembic Pharms. Ltd., 22-1450 (D. Del.) | Nov. 3, 2022 | Hon. Gregory B. Williams | Uptravi® (selexipag for injection) | 8,791,122 9,284,280 |
| Bristol-Myers Squibb Co. v. Handa Oncology, LLC, 22-6968 (N.D. Cal.) | Nov. 7, 2022 | Hon. Trina L Thompson | Sprycel® (dasatinib tablets) | 7,491,725 8,680,103 |
| Amicus Therapeutics US, LLC v. Teva Pharms. USA, Inc., 22-1461 (D. Del.) | Nov. 7, 2022 | Hon. Colm F. Connolly | Galafold® (migalastat capsules) | 9,000,011 9,987,263 10,383,864 10,406,143 9,999,618 10,925,866 10,813,921 RE48,608 |
| Amicus Therapeutics US, LLC v. Teva Pharms. USA, Inc., 22-1462 (D. Del.) | Nov. 7, 2022 | Hon. Colm F. Connolly | Galafold® (migalastat capsules) | 10,792,279 10,806,727 10,849,889 10,849,890 10,874,655 11,278,536 11,278,537 11,278,538 11,278,539 11,278,540 11,357,761 11,357,762 11,357,763 11,389,436 11,389,437 11,458,128 11,304,940 11,357,764 11,357,765 11,376,244 11,426,396 10,874,657 11,357,784 |
| Amicus Therapeutics US, LLC v. Lupin Ltd., 22-1465 (D. Del.) | Nov. 7, 2022 | Hon. Colm F. Connolly | Galafold® (migalastat capsules) | 10,792,279 10,806,727 10,849,889 10,849,890 10,874,655 11,278,536 11,278,537 11,278,538 11,278,539 11,278,540 11,357,761 11,357,762 11,357,763 11,389,436 11,389,437 11,458,128 11,304,940 11,357,764 11,357,765 11,376,244 11,426,396 10,874,657 11,357,784 |
| Amicus Therapeutics US, LLC v. Aurobindo Pharma Ltd., 22-1467 (D. Del.) | Nov. 7, 2022 | Hon. Colm F. Connolly | Galafold® (migalastat capsules) | 10,792,279 10,806,727 10,849,889 10,849,890 10,874,655 11,278,536 11,278,537 11,278,538 11,278,539 11,278,540 11,357,761 11,357,762 11,357,763 11,389,436 11,389,437 11,458,128 11,304,940 11,357,764 11,357,765 11,376,244 11,426,396 10,874,657 11,357,784 |
| Ferring Pharms. Inc. v. Jiangsu Hansoh Pharm. Group Co., Ltd., 22-1474 (D. Del.) | Nov. 9, 2022 | Hon. Maryellen Noreika | Firmagon® (degarelix for injection) | 9,579,359 10,729,739 10,973,870 9,415,085 10,695,398 8,828,938 |
| Taiho Pharm. Co., Ltd. v. Natco Pharma Ltd., 22-1480 (D. Del.) | Nov. 10, 2022 | Hon. Colm F. Connolly | Lonsurf® (tipiracil HCl / trifluridine tablets) | 10,456,399 10,960,004 |
| Bayer Intellectual Property GmbH v. Epic Pharma, LLC, 22-1481 (D. Del.) | Nov. 10, 2022 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 9,539,218 10,828,310 |
| Ferring Pharms. Inc. v. Jiangsu Hansoh Pharm. Group Co., Ltd., 22-0616 (W.D.N.C.) | Nov. 10, 2022 | Hon. Judge Max O. Cogburn, Jr. | Firmagon® (degarelix for injection) | 9,579,359 10,729,739 10,973,870 9,415,085 10,695,398 8,828,938 |
| Otsuka Pharm. Co. Ltd. v. Mylan Labs. Ltd., 22-0114 (N.D.W.V.) | Nov. 10, 2022 | Hon. Thomas S. Kleeh | Abilify Maintena® (aripiprazole extended-release injection) | 11,400,087 |
| Pfizer Inc. v. Sinotherapeutics Inc., 22-1484 (D. Del.) | Nov. 11, 2022 | Hon. Gregory B. Williams | Xeljanz® XR (tofacitinib citrate extended-release tablets) | 10,639,309 11,253,523 |
| Pfizer Inc. v. Sun Pharm. Indus. Ltd., 22-1501 (D. Del.) | Nov. 16, 2022 | Hon. Colm F. Connolly | Xeljanz® XR (tofacitinib citrate extended-release tablets) | RE41,783 |
| Merck Sharp & Dohme LLC v. Hetero USA, Inc., 22-6820 (D.N.J.) | Nov. 28, 2022 | Hon. Esther Salas | Delstrigo® (doravirine / lamivudine / tenofovir disoproxil fumarate tablets) | 10,603,282 10,842,751 |
| Apotex Inc. v. Eli Lilly & Co., 22-2342 (S.D. Ind.) | Dec. 6, 2022 | Hon. Jane Magnus-Stinson | Forteo® (teriparatide injection) | 7,517,334 |
| UCB, Inc. v. Mylan Technologies Inc., 22-0216 (D. Vt.) | Dec. 12, 2022 | Hon. Christina Reiss | Neupro® (rotigotine transdermal system) | 8,246,979 8,246,980 10,130,589 10,350,174 |
| Bayer Pharma AG v. Apotex Inc., 22-1596 (D. Del.) | Dec. 14, 2022 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Azurity Pharms., Inc. v. Glenmark Pharms. Ltd., 22-1604 (D. Del.) | Dec. 16, 2022 | Hon. Maryellen Noreika | Edarbi® (azilsartan medoxomil tablets) | 9,066,936 |
| Astellas Pharma Inc. v. Sun Pharm. Indus., Inc., 22-7357 (D.N.J.) | Dec. 16, 2022 | Hon. John Michael Vazquez | Xtandi® (enzalutamide tablets) | 7,709,517 |
| Taiho Pharm. Co., Ltd. v. Eugia Pharma Specialties Ltd., 22-1611 (D. Del.) | Dec. 20, 2022 | Hon. Colm F. Connolly | Lonsurf® (trifluridine / tipiracil tablets) | 10,456,399 10,960,004 |
| Takeda Pharms. America, Inc. v. Teva Pharms., Inc., 22-7454 (D.N.J.) | Dec. 21, 2022 | Hon. Kevin McNulty | Iclusig® (ponatinib HCl tablets) | 9,493,470 11,192,895 11,192,897 11,384,086 |
| AstraZeneca AB v. Unichem Labs. Ltd., 22-7472 (D.N.J.) | Dec. 22, 2022 | Hon. Karen M. Williams | Brilinta® (ticagrelor tablets) | RE46,276 10,300,065 |
| Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., 22-7528 (D.N.J.) | Dec. 27, 2022 | Hon. Claire C. Cecchi | Hetlioz® (tasimelteon capsules) | 11,285,129 |
| Vanda Pharms. Inc. v. Apotex Inc., 22-7529 (D.N.J.) | Dec. 27, 2022 | Hon. Claire C. Cecchi | Hetlioz® (tasimelteon capsules) | 11,285,129 |
| Vanda Pharms. Inc. v. Apotex Inc., 22-62432 (S.D. Fla.) | Dec. 28, 2022 | Hon. Cecilia M. Altonaga | Hetlioz® (tasimelteon capsules) | 11,285,129 |
| Mallinckrodt Pharms. Ireland Ltd. v. Airgas Therapeutics LLC, 22-1648 (D. Del.) | Dec. 30, 2022 | Hon. Richard G. Andrews | INOmax® (nitric oxide gas) | 9,770,570 8,282,966 8,293,284 8,431,163 8,795,741 8,291,904 8,573,209 8,573,210 8,776,794 8,776,795 9,265,911 9,279,794 9,295,802 9,408,993 |
| Ingenus Pharms., LLC v. Nevakar Injectables, Inc., 22-7603 (D.N.J.) | Dec. 30, 2022 | Hon. Michael A. Shipp | Cyclophosphamide for injection | 10,993,952 |
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