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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). |
|---|---|---|---|---|
| Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 24-0150 (D.N.J.) | Jan. 9, 2024 | Hon. Karen M. Williams | Yupelri® (revefenacin inhalation solution) | 11,858,898 |
| Heron Therapeutics, Inc. v. Mylan Pharms. Inc., 24-0043 (D. Del.) | Jan. 11, 2024 | Hon. William C. Bryson | Aponvie® (aprepitant injection) | 9,561,229 9,808,465 9,974,742 9,974,793 9,974,794 10,500,208 10,624,850 10,953,018 11,173,118 11,744,800 |
| Axsome Malta Ltd. v. Hetero USA Inc., 24-0196 (D.N.J.) | Jan. 11, 2024 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 11,771,666 11,771,667 11,779,554 11,793,776 |
| Galderma Labs., L.P. v. Teva Pharms., Inc., 24-0197 (D.N.J.) | Jan. 11, 2024 | Hon. Michael A. Shipp | Aklief® (trifarotene cream) | 9,084,778 9,498,465 |
| Novo Nordisk Inc. v. Mylan Pharms. Inc., 24-0050 (D. Del.) | Jan. 12, 2024 | Hon. Colm F. Connolly | Wegovy® (semaglutide injection) | 11,752,198 |
| Upsher-Smith Labs., LLC v. AMTA Labs Ltd., 24-0058 (D. Del.) | Jan. 17, 2024 | Hon. Gregory B. Williams | Qudexy® XR (topiramate extended-release capsules) | 10,363,224 |
| Eagle Pharms., Inc. v. Apotex Inc., 24-0064 (D. Del.) | Jan. 17, 2024 | Hon. Jennifer L. Hall | Belrapzo® (bendamustine HCl injection) | 11,844,783 11,872,214 |
| Eagle Pharms., Inc. v. Slayback Pharma LLC, 24-0065 (D. Del.) | Jan. 17, 2024 | Hon. Jennifer L. Hall | Belrapzo® (bendamustine HCl injection) | 11,844,783 11,872,214 |
| Eagle Pharms., Inc. v. Baxter Healthcare Corp., 24-0066 (D. Del.) | Jan. 17, 2024 | Hon. Jennifer L. Hall | Belrapzo® (bendamustine HCl injection) | 11,844,783 11,872,214 |
| Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 24-0309 (D.N.J.) | Jan. 18, 2024 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 11,771,666 11,771,667 11,779,554 11,793,776 |
| Novo Nordisk Inc. v. Rio Biopharms., Inc., 24-0330 (D.N.J.) | Jan. 19, 2024 | Hon. Renee Marie Bumb | Victoza® (liraglutide recombinant solution injection) | 8,114,833 9,265,893 |
| Galderma Labs., L.P. v. Taro Pharms. Inc., 24-0333 (D.N.J.) | Jan. 19, 2024 | Hon. Michael A. Shipp | Aklief® (trifarotene cream) | 9,084,778 9,498,465 |
| Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. Granules India Ltd., 24-0081 (D. Del.) | Jan. 22, 2024 | Hon. Richard G. Andrews | Desyrel® (trazodone HCl tablets) | 8,133,893 |
| Heron Therapeutics, Inc. v. Slayback Pharma LLC, 24-0423 (D.N.J.) | Jan. 24, 2024 | Hon. Jamel K. Semper | Cinvanti® (aprepitant injectable emulsion) | 9,561,229 9,808,465 9,974,742 9,974,793 9,974,794 10,500,208 10,624,850 10,953,018 11,173,118 11,744,800 |
| Dr. Reddy’s Labs. S.A. v. Eye Therapies, LLC, IPR2024-00467 (PTAB) | Jan. 24, 2024 | N/A | Lumify® (brimonidine tartrate solution) | 11,833,245 |
| Advanced Accelerator Applications USA, Inc. v. Lantheus Medical Imaging, Inc., 24-0095 (D. Del.) | Jan. 25, 2024 | Hon. Maryellen Noreika | Lutathera® (lutetium Lu 177 dotatate injection) | 10,596,276 |
| Celgene Corp. v. Amneal Pharms. of NY, LLC, 24-0500 (D.N.J.) | Jan. 26, 2024 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,465,800 7,855,217 |
| Bayer Pharma AG v. Lupin Ltd., 24-0138 (D. Del.) | Feb. 2, 2024 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Eagle Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 24-0637 (D.N.J.) | Feb. 2, 2024 | Hon. Jamel K. Semper | Belrapzo® (bendamustine HCl injection) | 11,844,783 11,872,214 |
| AstraZeneca Pharms. LP v. Sandoz Inc., 24-0641 (D.N.J.) | Feb. 2, 2024 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) | 7,449,464 8,475,842 8,859,562 11,633,396 |
| AbbVie Inc. v. Hetero Labs Ltd., 24-0151 (D. Del.) | Feb. 5, 2024 | Hon. Jennifer L. Hall | Orilissa® (elagolix sodium tablets) | 11,690,845 11,690,854 |
| AbbVie Inc. v. Prinston Pharm. Inc., 24-0152 (D. Del.) | Feb. 5, 2024 | Hon. Jennifer L. Hall | Orilissa® (elagolix sodium tablets) | 11,690,845 11,690,854 |
| AbbVie Inc. v. Sun Pharm. Indus. Ltd., 24-0153 (D. Del.) | Feb. 5, 2024 | Hon. Jennifer L. Hall | Orilissa® (elagolix sodium tablets) | 11,690,845 11,690,854 |
| AbbVie Inc. v. Zenara Pharma Private Ltd., 24-0154 (D. Del.) | Feb. 5, 2024 | Hon. Jennifer L. Hall | Orilissa® (elagolix sodium tablets) | 11,690,845 11,690,854 |
| Novo Nordisk Inc. v. Rio Biopharmaceuticals, Inc., 24-0688 (D.N.J.) | Feb. 5, 2024 | Hon. Renee Marie Bumb | Saxenda® (liraglutide injection solution) | 8,114,833 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 11,446,443 RE46,363 |
| Nexus Pharms., LLC v. Exela Pharma Sciences, LLC, PGR2024-00016 (PTAB) | Feb. 8, 2024 | N/A | Elcys® (cysteine HCl injection solution) | 11,642,370 |
| UCB, Inc. v. Prinston Pharm. Inc., 24-0167 (D. Del.) | Feb. 8, 2024 | Hon. Colm F. Connolly | Briviact® (brivaracetam tablets) | 6,911,461 |
| Axsome Malta Ltd. v. Sandoz Inc., 24-0860 (D.N.J.) | Feb. 14, 2024 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 11,771,666 11,771,667 11,779,554 11,793,776 11,839,598 11,839,599 11,850,226 11,850,227 11,850,228 |
| Eagle Pharms., Inc. v. Accord Healthcare Inc., 24-0095 (E.D.N.C.) | Feb. 16, 2024 | Hon. James C. Dever, III | Belrapzo® (bendamustine HCl injection) | 11,844,783 11,872,214 |
| Teva Branded Pharm. Products R&D, Inc. v. Cipla USA, Inc., 24-0909 (D.N.J.) | Feb. 16, 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 |
| Dr. Reddy’s Labs. S.A. v. Eye Therapies, LLC, IPR2024-00563 (PTAB) | Feb. 21, 2024 | N/A | Lumify® (brimonidine tartrate ophthalmic solution) | 11,596,600 |
| American Regent, Inc. v. Somerset Therapeutics, LLC, 24-1022 (D.N.J.) | Feb. 22, 2024 | Hon. Brian R. Martinotti | Tralement® (trace elements injection 4*, USP) | 11,786,548 |
| American Regent, Inc. v. Somerset Therapeutics, LLC, 24-1030 (D.N.J.) | Feb. 22, 2024 | Hon. Brian R. Martinotti | Multrys® (trace elements injection 4*, USP) | 11,786,548 |
| American Regent, Inc. v. Somerset Therapeutics, LLC, 24-0248 (D Del.) | Feb. 23, 2024 | Hon. Maryellen Noreika | Tralement® (trace elements injection 4*, USP) | 11,786,548 |
| American Regent, Inc. v. Somerset Therapeutics, LLC, 24-0249 (D. Del.) | Feb. 2324-, 2024 | Hon. Maryellen Noreika | Multrys® (trace elements injection 4*, USP) | 11,786,548 |
| American Regent, Inc. v. RK Pharma, Inc., 24-1169 (D.N.J.) | Feb. 28, 2024 | Hon. Brian R. Martinotti | Tralement® (trace elements injection 4*, USP) Multrys® (trace elements injection 4*, USP) | 11,786,548 |
| American Regent, Inc. v. RK Pharma, Inc., 24-0268 (D. Del.) | Feb. 29, 2024 | Hon. Maryellen Noreika | Tralement® (trace elements injection 4*, USP) Multrys® (trace elements injection 4*, USP) | 11,786,548 |
| Apotex Inc. v. Novo Nordisk A/S, IPR2024-00631 (PTAB) | Mar. 1, 2024 | N/A | Ozempic® (semaglutide injection) | 10,335,462 |
| Pfizer Inc. v. MSN Labs. Private Ltd., 24-0315 (D. Del.) | Mar. 8, 2024 | Hon. Jennifer L. Hall | Oxbryta® (voxelotor tablets) | 9,447,071 10,493,035 10,722,502 11,020,382 11,452,720 |
| Pfizer Inc. v. Zydus Lifesciences Ltd., 24-0316 (D. Del.) | Mar. 8, 2024 | Hon. Jennifer L. Hall | Oxbryta® (voxelotor tablets) | 9,447,071 10,493,035 10,722,502 11,020,382 11,452,720 |
| Beigene USA, Inc. v. MSN Pharms. Inc., 24-1971 (D.N.J.) | Mar. 8, 2024 | Hon. Zahid N. Quraishi | Brukinsa® (zanubrutinib capsules) | 10,927,117 11,591,340 11,786,531 11,851,437 |
| Beigene USA, Inc. v. Sandoz Inc., 24-1972 (D.N.J.) | Mar. 8, 2024 | Hon. Zahid N. Quraishi | Brukinsa® (zanubrutinib capsules) | 10,927,117 11,591,340 |
| American Regent, Inc. v. Apotex, Inc., 24-2268 (D.N.J.) | Mar. 11, 2024 | Hon. Brian R. Martinotti | Tralement® (trace elements injection 4*, USP) Multrys® (trace elements injection 4*, USP) | 11,786,548 |
| America Regent, Inc. v. Apotex, Inc., 24-0327 (D. Del.) | Mar. 13, 2024 | Hon. Maryellen Noreika | Tralement® (trace elements injection 4*, USP) Multrys® (trace elements injection 4*, USP) | 11,786,548 |
| Bayer Intellectual Property GmbH v. Prinston Pharm., Inc., 24-0336 (D. Del.) | Mar. 14, 2024 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 9,539,218 10,828,310 |
| Merck Sharp & Dohme B.V. v. Hikma Pharms. USA Inc., 24-3206 (D.N.J.) | Mar. 15, 2024 | Hon. Claire C. Cecchi | Bridion® (sugammadex injection) | RE44,733 |
| Actelion Pharms. Ltd. v. Torrent Pharms. Ltd., 24-3990 (D.N.J.) | Mar. 19, 2024 | Hon. Georgette Castner | Opsumit® (macitentan tablets) | 7,094,781 10,946,015 |
| Axsome Malta Ltd. v. Hetero USA Inc., 24-3999 (D.N.J.) | Mar. 19, 2024 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 11,839,598 11,839,599 11,850,226 11,850,227 11,850,228 11,857,528 11,865,098 11,872,203 11,872,204 |
| Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 24-4002 (D.N.J.) | Mar. 19, 2024 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 11,839,598 11,850,226 11,850,227 11,850,228 11,857,528 11,865,098 11,872,203 11,872,204 |
| Arcutis Biotherapeutics, Inc. v. Padagis Israel Pharms. Ltd., 24-4231 (D.N.J.) | Mar. 26, 2024 | Hon. Edward S. Kiel | Zoryve® (roflumilast cream) | 9,884,050 9,907,788 10,940,142 11,129,818 11,793,796 11,819,496 |
| Arcutis Biotherapeutics, Inc. v. Padagis Israel Pharms. Ltd., 24-0391 (D. Del.) | Mar. 27, 2024 | Hon. Colm F. Connolly | Zoryve® (roflumilast cream) | 9,884,050 9,907,788 10,940,142 11,129,818 11,793,796 11,819,496 |
| Intra-Cellular Therapies, Inc. v. Aurobindo Pharma Ltd., 24-4264 (D.N.J.) | Mar. 27, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 9,956,227 10,695,345 10,960,009 11,026,951 11,690,842 11,753,419 11,806,348 RE48,839 |
| Azurity Pharms., Inc. v. Hetero Labs Ltd., 24-0396 (D. Del.) | Mar. 28, 2024 | Hon. Maryellen Noreika | Edarbi® (azilsartan medoxomil tablets) | 9,066,936 |
| Bayer Healthcare LLC v. Aurobindo Pharma Ltd., 24-0399 (D. Del.) | Mar. 28, 2024 | Hon. William C. Bryson | Children’s Astepro® Allergy OTC (azelastine HCl nasal spray) | 8,071,073 8,518,919 9,919,050 |
| Intra-Cellular Therapies, Inc. v. Alkem Labs. Ltd., 24-4312 (D.N.J.) | Mar. 28, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 9,956,227 10,695,345 10,960,009 11,026,951 11,052,084 11,690,842 11,753,419 11,806,348 RE48,839 |
| Intra-Cellular Therapies, Inc. v. Dr. Reddy’s Labs Inc., 24-4314 (D.N.J.) | Mar. 28, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 8,648,077 9,168,258 9,199,995 9,616,061 9,956,227 10,117,867 10,464,938 10,695,345 10,960,009 11,026,951 11,052,084 11,690,842 11,753,419 11,806,348 RE48,825 RE48,839 |
| Intra-Cellular Therapies, Inc. v. Hetero USA, Inc., 24-4317 (D.N.J.) | Mar. 28, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 8,648,077 9,956,227 10,695,345 10,960,009 11,026,951 11,052,084 11,690,842 11,753,419 11,806,348 RE48,839 |
| Intra-Cellular Therapies, Inc. v. MSN Labs. Private Ltd., 24-4325 (D.N.J.) | Mar. 28, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 9,956,227 10,695,345 10,960,009 11,026,951 11,052,084 11,690,842 11,753,419 11,806,348 RE48,839 |
| Intra-Cellular Therapies, Inc. v. Sandoz Inc., 24-4327 (D.N.J.) | Mar. 28, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 8,648,077 9,168,258 9,199,995 9,616,061 9,956,227 10,117,867 10,464,938 10,695,345 10,960,009 11,026,951 11,052,084 11,690,842 11,753,419 11,806,348 RE48,825 RE48,839 |
| Intra-Cellular Therapies, Inc. v. Zydus Pharms. (USA) Inc., 24-4330 (D.N.J.) | Mar. 28, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 10,695,345 11,052,084 11,690,842 11,753,419 11,806,348 |
| Incyte Corp. v. Apotex Inc., 24-4366 (D.N.J.) | Mar. 28, 2024 | Hon. Christine P. O’Hearn | Jakafi® (ruxolitinib tablets) | 7,598,257 8,415,362 8,722,693 8,822,481 8,829,013 |
| AbbVie Inc. v. Alembic Pharms. Ltd., 24-0405 (D. Del.) | Mar. 29, 2024 | Hon. Colm F. Connolly | Lastacaft® (alcaftadine ophthalmic solution) | 8,664,215 10,617,695 |
| AbbVie Inc. v. Aurobindo Pharma U.S.A., Inc., 24-4403 (D.N.J.) | Mar. 29, 2024 | Hon. Zahid N. Quraishi | Ubrelvy® (Ubrogepant tablets) | 10,117,836 11,717,515 11,857,542 11,925,709 |
| Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S., 24-4404 (D.N.J.) | Mar. 29, 2024 | Hon. Stanley R. Chesler | ProAir® HFA (albuterol sulfate inhalation aerosol) | 8,132,712 9,463,289 9,808,587 10,022,509 10,022,510 10,086,156 10,561,808 10,695,512 11,395,889 |
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