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New ANDA Cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Second 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). |
|---|---|---|---|---|
| United Therapeutics Corp. v. ANI Pharms., Inc., 21-0489 (D. Del.) | Apr. 1, 2021 | Hon. Richard G. Andrews | Orenitram® (treprostinil extended-release tablets) | 7,417,070 7,544,713 8,252,839 8,349,892 8,410,169 8,747,897 9,050,311 9,278,901 9,393,203 9,422,223 9,593,066 9,604,901 |
| EPI Health, LLC v. Perrigo UK Finco Ltd. Partnership, 21-0498 (D. Del.) | Apr. 5, 2021 | Hon. Colm F. Connolly | Rhofade® (oxymetazoline HCl cream) | 7,812,049 8,420,688 8,815,929 8,883,838 9,974,773 10,335,391 10,751,325 |
| Azurity Pharms., Inc. v. Amneal Pharms. LLC, 21-8717 (D.N.J.) | Apr. 8, 2021 | Hon. Freda L. Wolfson | Katerzia® (amlodipine oral suspension) | 10,695,329 10,799,453 10,894,039 10,952,998 |
| Purdue Pharma L.P. v. Collegium Pharm., Inc., 21-10598 (D. Mass.) | Apr. 9, 2021 | Hon. F. Dennis Saylor, IV | OxyContin® (oxycodone HCl extended-release tablets) Xtampza® ER (oxycodone extended-release capsules) | 10,407,434 |
| Boehringer Ingelheim Pharms. Inc. v. Lupin Ltd., 21-0530 (D. Del.) | Apr. 13, 2021 | Hon. Colm F. Connolly | Trijardy® XR (empagliflozin / linagliptin / metformin HCl extended-release tablets) | 8,551,957 9,155,705 9,415,016 9,949,998 10,022,379 10,258,637 10,406,172 |
| Duchesnay Inc. v. Hetero Labs Ltd., 21-0538 (D. Del.) | Apr. 14, 2021 | Hon. Leonard P. Stark | Osphena® (ospemifene tablets) | 8,642,079 |
| CMP Development, LLC v. Amneal Pharms. LLC, 21-0549 (D. Del.) | Apr. 16, 2021 | Hon. Maryellen Noreika | CaroSpir® (spironolactone oral suspension) | 9,757,394 10,493,083 10,624,906 10,660,907 10,888,570 |
| AstraZeneca AB v. Zydus Pharms. (USA), Inc., 21-0550 (D. Del.) | Apr. 16, 2021 | Hon. Richard G. Andrews | Tagrisso® (osimertinib mesylate tablets) | 10,183,020 |
| Bayer Pharma AG v. Accord Healthcare Inc., 21-0566 (D. Del.) | Apr. 22, 2021 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Bausch Health Ireland Ltd. v. MSN Labs. Private Ltd., 21-10057 (D.N.J.) | Apr. 22, 2021 | Hon. Stanley R. Chesler | Trulance® (plecanatide tablets) | 7,041,786 7,799,897 8,637,451 9,610,321 9,616,097 9,919,024 9,925,231 10,011,637 |
| Otsuka Pharm. Co., Ltd. v. Sandoz Inc., 21-0580 (D. Del.) | Apr. 26, 2021 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | RE48,059 |
| Celgene Corp. v. Hikma Pharms. USA, Inc., 21-10398 (D.N.J.) | Apr. 28, 2021 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,189,740 7,465,800 7,855,217 7,968,569 8,404,717 8,530,498 8,648,095 9,056,120 9,101,621 9,101,622 |
| Bausch Health Ireland Ltd. v. Mylan Labs. Ltd., 21-10403 (D.N.J.) | Apr. 28, 2021 | Hon. Stanley R. Chesler | Trulance® (plecanatide tablets) | 7,041,786 7,799,897 8,637,451 9,610,321 9,616,097 9,919,024 9,925,231 10,011,637 |
| Bausch Health Ireland Ltd. v. Mylan Labs. Ltd., 21-0611 (D. Del.) | Apr. 29, 2021 | Hon. Leonard P. Stark | Trulance® (plecanatide tablets) | 7,041,786 7,799,897 8,637,451 9,610,321 9,616,097 9,919,024 9,925,231 10,011,637 |
| Mayne Pharma LLC v. Perrigo Israel Pharms. Ltd., 21-0612 (D. Del.) | Apr. 29, 2021 | Hon. Colm F. Connolly | Lexette® (halobetasol propionate topical foam) | 10,857,159 |
| Bausch Health Ireland Ltd. v. Mylan Labs. Ltd., 21-0573 (W.D. Pa.) | Apr. 30, 2021 | Hon. W. Scott Hardy | Trulance® (plecanatide tablets) | 7,041,786 7,799,897 8,637,451 9,610,321 9,616,097 9,919,024 9,925,231 10,011,637 |
| Novartis Pharms. Corp. v. Handa Neuroscience, LLC, 21-0645 (D. Del.) | 4-May-21 | Hon. Leonard P. Stark | Gilenya® (fingolimod tablets) | 9,187,405 10,543,179 |
| Novartis Pharms. Corp. v. Handa Neuroscience, LLC, 21-3397 (N.D. Ca.) | 6-May-21 | Hon. Edward J. Davila | Gilenya® (fingolimod tablets) | 9,187,405 10,543,179 |
| Amgen Inc. v. Aurobindo Pharma Ltd., 21-0662 (D. Del.) | 6-May-21 | Hon. Maryellen Noreika | Parsabiv® (etelcalcetide for injection) | 9,820,938 10,344,765 |
| Astellas Pharma Inc. v. Sandoz Inc., 21-0664 (D. Del.) | 7-May-21 | Hon. Joseph F. Bataillon | Myrbetriq® (mirabegron extended-release tablets) | 10,842,780 |
| Astellas US LLC v. American Regent, Inc., 21-0671 (D. Del.) | 7-May-21 | Hon. Colm F. Connolly | Lexiscan® (regadenoson for injection) | 8,106,183 RE47,301 8,524,883 |
| Jazz Pharms., Inc. v. Avadel Pharms. PLC, 21-0691 (D. Del.) | 12-May-21 | Hon. Maryellen Noreika | Xyrem® (sodium oxybate oral solution) | 8,731,963 10,758,488 10,813,885 10,959,956 10,966,931 |
| Teva Pharms. Int’l GmbH v. Dr. Reddy’s Labs., Ltd., 21-0695 (D. Del.) | 13-May-21 | Hon. Colm F. Connolly | Bendeka® (bendamustine HCl for injection) | 8,609,707 9,265,831 9,572,796 9,572,797 9,034,908 9,144,568 9,572,887 9,597,397 9,597,398 9,597,399 9,000,021 9,579,384 10,010,533 10,052,385 |
| Melinta Therapeutics, LLC v. Nexus Pharms., Inc., 21-11198 (D.N.J.) | 13-May-21 | Hon. Brian R. Martinotti | Minocin® (minocycline for injection) | 9,278,105 9,084,802 |
| Melinta Therapeutics, LLC v. Nexus Pharms., Inc., 21-2636 (N.D. Ill.) | 14-May-21 | Hon. John F. Kness | Minocin® (minocycline for injection) | 9,278,105 9,084,802 |
| Bausch Health Ireland Ltd. v. Lupin Ltd., 21-11258 (D.N.J.) | 14-May-21 | Hon. Renee Marie Bumb | Plenvu® (PEG 3350 / sodium ascorbate / sodium sulfate / ascorbic acid / sodium chloride / potassium chloride oral solution) | 10,918,723 |
| Celgene Corp. v. Biocon Pharma Ltd., 21-11261 (D.N.J.) | 14-May-21 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,189,740 7,465,800 7,855,217 7,968,569 8,404,717 8,530,498 8,648,095 9,056,120 9,101,621 9,101,622 |
| Amgen Inc. v. MSN Labs. Private Ltd., 21-0712 (D. Del.) | 19-May-21 | Hon. Maryellen Noreika | Parsabiv® (etelcalcetide for injection) | 8,377,880 8,999,932 9,278,995 9,701,712 9,820,938 10,344,765 |
| Bayer Pharma AG v. Dr. Reddy’s Labs., Inc., 21-0732 (D. Del.) | 24-May-21 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Almirall, LLC v. Acrux DDS Pty. Ltd., 21-11948 (D.N.J.) | 28-May-21 | Hon. Madeline Cox Arleo | Aczone® (dapsone gel) | 9,517,219 |
| Supernus Pharms., Inc. v. Riconpharma LLC, 21-12133 (D.N.J.) | 3-Jun-21 | Hon. Freda L. Wolfson | 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 |
| Merck Sharp & Dohme Corp. v. Alkem Labs. Ltd., 21-0824 (D. Del.) | 4-Jun-21 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) | 7,326,708 |
| Taiho Pharm. Co., Ltd. v. Accord Healthcare Inc., 21-0838 (D. Del.) | 9-Jun-21 | Hon. Colm F. Connolly | Lonsurf® (tipiracil HCl / trifluridine tablets) | 10,960,004 |
| Newron Pharms. S.p.A. v. Aurobindo Pharma Ltd., 21-0843 (D. Del.) | 10-Jun-21 | Hon. Richard G. Andrews | Xadago® (safinamide tablets) | 8,076,515 8,278,485 8,283,380 |
| Pfizer Inc. v. MSN Pharms. Inc., 21-0858 (D. Del.) | 15-Jun-21 | Hon. Colm F. Connolly | Ibrance® (palbociclib tablets) | 10,723,730 |
| Exelixis, Inc. v. Teva Pharm. Indus. Ltd., 21-0871 (D. Del.) | 17-Jun-21 | Hon. Richard G. Andrews | Cabometyx® (cabozantinib s-malate tablets) | 9,724,342 10,039,757 10,034,873 |
| Novartis Pharms. Corp. v. Fresenius Kabi USA, LLC, 21-0870 (D. Del.) | 17-Jun-21 | Hon. Leonard P. Stark | Kisqali® (ribociclib tablets) Kisqali® Femara® Co-pack (ribociclib / letrozole tablets) | 8,324,225 8,415,355 8,685,980 8,962,630 9,193,732 9,416,136 9,868,739 10,799,506 |
| Apotex Inc. v. Pfizer Inc., IPR2021-01132 (PTAB) | 17-Jun-21 | N/A | Chantix® (varenicline tartrate tablets) | 6,890,927 |
| AstraZeneca AB v. Alembic Pharms. Ltd., 21-0875 (D. Del.) | 18-Jun-21 | Hon. Richard G. Andrews | Brilinta® (ticagrelor tablets) | 8,425,934 10,300,065 |
| TherapeuticsMD, Inc. v. Teva Pharms. USA, Inc., 21-12794 (D.N.J.) | 21-Jun-21 | Hon. Brian R. Martinotti | Imvexxy® (estradiol vaginal inserts) | 10,888,516 |
| Tris Pharma, Inc. v. Ascent Pharms., Inc., 21-12867 (D.N.J.) | 22-Jun-21 | Hon. Kevin McNulty | QuilliChew ER® (methylphenidate HCl extended-release chewable tablets) | 8,999,386 9,295,642 9,545,399 9,844,544 |
| Azurity Pharms., Inc. v. Bionpharma Inc., 21-12870 (D.N.J.) | 22-Jun-21 | Hon. Michael A. Shipp | Epaned® (enalapril maleate oral solution) | 11,040,023 |
| Otsuka Pharm. Co., Ltd. v. Lupin Ltd., 21-0900 (D. Del.) | 23-Jun-21 | Hon. Richard G. Andrews | Jynarque® (tolvaptan tablets) | 8,501,730 10,905,694 |
| Celgene Corp. v. Torrent Pharms. Ltd., 21-12927 (D.N.J.) | 23-Jun-21 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,189,740 7,465,800 7,855,217 7,968,569 8,404,717 8,530,498 8,648,095 9,056,120 9,101,621 9,101,622 |
| Takeda Pharms. America, Inc. v. Apotex, Inc., 21-12998 (D.N.J.) | 25-Jun-21 | Hon. Kevin McNulty | Iclusig® (ponatinib HCl tablets) | 9,493,470 |
| Pfizer Inc. v. Qilu Pharm. Co., Ltd., 21-0929 (D. Del.) | 29-Jun-21 | Hon. Colm F. Connolly | Ibrance® (palbociclib capsules) | 10,723,730 |
| Teva Pharms. Int’l GmbH v. Accord Healthcare Inc., 21-0952 (D. Del.) | 29-Jun-21 | Hon. Colm F. Connolly | Bendeka® (bendamustine HCl injection) | 8,609,707 9,265,831 9,572,796 9,572,797 9,034,908 9,144,568 9,572,887 9,597,397 9,597,398 9,597,399 9,000,021 9,579,384 10,010,533 10,052,385 |
| Amphastar Pharms. Inc. v. Eli Lilly and Co., 21-1922 (S.D. Ind.) | 29-Jun-21 | Hon. Richard L. Young | Forteo® (teriparatide injection) | 7,517,334 |
| Novartis Pharms. Corp. v. Micro Labs Ltd., 21-0969 (D. Del.) | 30-Jun-21 | Hon. Leonard P. Stark | Xiidra® (lifitegrast ophthalmic solution) | 7,314,938 7,745,460 7,790,743 7,928,122 9,216,174 10,124,000 8,084,047 8,592,450 8,168,655 8,367,701 9,447,077 8,927,574 9,353,088 9,890,141 9,085,553 |
| Astellas Pharma Inc. v. Sandoz Inc., 21-13177 (D.N.J.) | 30-Jun-21 | Hon. John Michael Vazquez | Xtandi® (enzalutamide tablets) | 7,709,517 8,183,274 |
GENERICally Speaking Spring 2021
GENERICally Speaking Spring 2021
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