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New ANDA Cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Third 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). |
|---|---|---|---|---|
| Novartis Pharms. Corp. v. MSN Pharms. Inc., 21-0981 (D. Del.) | 1-Jul-21 | Hon. Leonard P. Stark | Kisqali® Femara® Co-pack (ribociclib / letrozole tablets) |
8,324,225 8,415,355 8,685,980 8,962,630 9,416,136 |
| AstraZeneca AB v. Alembic Pharms. Ltd., 21-0982 (D. Del.) | 1-Jul-21 | Hon. Richard G. Andrews | Tagrisso® (osimertinib mesylate tablets) | 10,183,020 |
| Teva Branded Pharm. Products R&D, Inc. v. Aurobindo Pharma Ltd., 21-13240 (D.N.J.) | 1-Jul-21 | Hon. Freda L. Wolfson | Austedo® (deutetrabenazine tablets) | 8,524,733 9,233,959 9,296,739 9,550,780 9,814,708 10,959,996 |
| Teva Branded Pharm. Products R&D, Inc. v. Lupin Ltd., 21-13247 (D.N.J.) | 1-Jul-21 | Hon. Freda L. Wolfson | Austedo® (deutetrabenazine tablets) | 9,233,959 9,296,739 9,550,780 9,814,708 |
| Orexo AB v. Sun Pharm. Indus. Ltd., 21-13320 (D.N.J.) | 2-Jul-21 | Hon. Zahid N. Quaraishi | Zubsolv® (buprenorphine / naloxone sublingual tablets) | 10,874,661 10,946,010 |
| Astellas Pharma Inc. v. Alkem Labs. Ltd., 21-0992 (D. Del.) | 6-Jul-21 | Hon. Joseph F. Bataillon | Myrbetriq® (mirabegron extended-release tablets) |
7,342,117 7,982,049 8,835,474 10,842,780 RE44,872 |
| Bayer Healthcare LLC v. Dr. Reddy’s Labs., Inc., 21-0997 (D. Del.) | 7-Jul-21 | Hon. Leonard P. Stark | Nexavar® (sorafenib tosylate tablets) | 9,737,488 |
| Bayer Pharma AG v. Taro Pharm. Indus. Ltd., 21-1000 (D. Del.) | 7-Jul-21 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Bayer Pharma AG v. Teva Pharms. USA, Inc., 21-1001 (D. Del.) | 7-Jul-21 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Horizon Medicines LLC v. Torrent Pharma Inc., 21-13396 (D.N.J.) | 7-Jul-21 | Hon. Stanley R. Chesler | Duexis® (ibuprofen / famotidine tablets) | 8,067,033 8,067,451 8,309,127 8,318,202 8,449,910 8,501,228 |
| Eli Lilly and Co. v. Radius Health, Inc., 21-1003 (D. Del.) | 8-Jul-21 | Hon. Colm F. Connolly | Tymlos® (abaloparatide for injection) Forteo® (teriparatide for injection) | 7,517,334 |
| Merck Sharp & Dohme Corp. v. Annora Pharma Private Ltd., 21-1006 (D. Del.) | 9-Jul-21 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) | 7,326,708 |
| Patheon Softgels Inc. v. Strides Pharma Inc., 21-13521 (D.N.J.) | 9-Jul-21 | Hon. Brian R. Martinotti | Naproxen sodium capsules | 9,693,978 9,693,979 10,022,344 10,028,925 |
| Nippon Shinyaku Co., Ltd. v. Sarepta Therapeutics, Inc., 21-1015 (D. Del.) | 13-Jul-21 | Hon. Leonard P. Stark | Vyondys® 53 (golodirsen for injection) | 10,227,590 10,266,827 10,385,092 10,407,461 10,487,106 10,647,741 10,662,217 10,683,322 9,708,361 9,994,851 |
| Vertex Pharms. Inc. v. Lupin Ltd., 21-1019 (D. Del.) | 13-Jul-21 | Hon. Richard G. Andrews | Kalydeco® (ivacaftor tablets) | 10,646,481 |
| Merz Pharms., LLC v. MSN Pharms. Inc., 21-1032 (D. Del.) | 15-Jul-21 | Hon. Richard G. Andrews | Cuvposa® (glycopyrrolate oral solution) | 7,638,552 7,816,396 |
| Merck Sharp & Dohme Corp. v. Dr. Reddy’s Labs., Inc., 21-1033 (D. Del.) | 15-Jul-21 | Hon. Richard G. Andrews | Janumet XR® (metformin HCl / sitagliptin phosphate extended release tablets) | 7,326,708 |
| Fresenius Kabi USA, LLC v. Baxter Healthcare Corp., 21-1040 (D. Del.) | 16-Jul-21 | Hon. Maryellen Noreika | Naropin® (ropivacaine HCl injection) | 7,828,787 7,857,802 8,118,802 8,162,915 |
| Neurocrine Biosciences, Inc. v. Lupin Ltd., 21-1042 (D. Del.) | 16-Jul-21 | Hon. Maryellen Noreika | Ingrezza® (valbenazine capsules) | 8,039,627 8,357,697 10,065,952 10,844,058 10,851,103 10,851,104 10,857,137 10,857,148 10,874,648 10,906,902 10,906,903 10,912,771 10,919,892 10,940,141 10,952,997 10,993,941 |
| Neurocrine Biosciences, Inc. v. Teva Pharms., Inc., 21-1043 (D. Del.) | 16-Jul-21 | Hon. Maryellen Noreika | Ingrezza® (valbenazine capsules) | 10,065,952 10,844,058 10,851,103 10,851,104 10,857,137 10,857,148 10,874,648 10,906,902 10,906,903 10,912,771 10,919,892 10,940,141 10,952,997 |
| Merz Pharms., LLC v. MSN Pharms. Inc., 21-13731 (D.N.J.) | 16-Jul-21 | Hon. Brian R. Martinotti | Cuvposa® (glycopyrrolate oral solution) | 7,638,552 7,816,396 |
| Bayer Pharma AG v. Mylan Pharms. Inc., 21-0099 (N.D.W.V.) | 22-Jul-21 | Hon. Irene M. Keeley | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Allergan USA, Inc. v. Alkem Labs. Ltd., 21-1061 (D. Del.) | 23-Jul-21 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 11,007,179 |
| Allergan USA, Inc. v. Aurobindo Pharma Ltd., 21-1062 (D. Del.) | 23-Jul-21 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 11,007,179 |
| Allergan USA, Inc. v. Hetero Labs Ltd., 21-1063 (D. Del.) | 23-Jul-21 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 11,007,179 |
| Allergan USA, Inc. v. MSN Labs. Private Ltd., 21-1064 (D. Del.) | 23-Jul-21 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 11,007,179 |
| Allergan USA, Inc. v. Sun Pharm. Indus. Ltd., 21-1065 (D. Del.) | 23-Jul-21 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 11,007,179 |
| Allergan USA, Inc. v. Zydus Pharms. (USA) Inc., 21-1066 (D. Del.) | 23-Jul-21 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 11,007,179 |
| Neurocrine Biosciences, Inc. v. Crystal Pharm. (Suzhou) Co., Ltd., 21-1067 (D. Del.) | 23-Jul-21 | Hon. Maryellen Noreika | Ingrezza® (valbenazine capsules) | 10,065,952 10,844,058 10,851,103 10,851,104 10,857,137 10,857,148 10,874,648 10,906,902 10,906,903 10,912,771 10,919,892 10,940,141 10,952,997 |
| Eli Lilly and Co. v. Sun Pharm. Indus. Ltd., 21-1092 (D. Del.) | 28-Jul-21 | Hon. Colm F. Connolly | Forteo® (teriparatide for injection) | 7,517,334 |
| Supernus Pharms., Inc. v. Torrent Pharms. Ltd., 21-14268 (D.N.J.) | 28-Jul-21 | Hon. Freda L. Wolfson | Trokendi XR® (topiramate extended-release capsues) | 8,298,576 8,298,580 8,663,683 8,877,248 8,889,191 8,992,989 9,549,940 9,555,004 9,622,983 10,314,790 |
| Jazz Pharms. Ireland Ltd. v. Lupin Ltd., 21-14271 (D.N.J.) | 28-Jul-21 | 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 |
| Novartis Pharms. Corp. v. MSN Pharms. Inc., 21-1102 (D. Del.) | 29-Jul-21 | Hon. Leonard P. Stark | Kisqali® (ribociclib tablets) | 8,324,225 8,415,355 8,685,980 8,962,630 9,416,136 |
| Novartis Pharms. Corp. v. Lupin Inc., 21-1105 (D. Del.) | 29-Jul-21 | Hon. Leonard P. Stark | Rydapt® (midostaurin capsules) | 8,575,146 |
| Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Inc., 21-1106 (D. Del.) | 29-Jul-21 | Hon. Leonard P. Stark | Rydapt® (midostaurin capsules) | 7,973,031 |
| Novartis Pharms. Corp. v. Lotus Pharm. Co., Ltd., 21-1107 (D. Del.) | 29-Jul-21 | Hon. Leonard P. Stark | Rydapt® (midostaurin capsules) | 7,973,031 8,222,244 8,575,146 |
| AstraZeneca AB v. Torrent Pharms. Ltd., 21-1116 (D. Del.) | 30-Jul-21 | Hon. Richard G. Andrews | Brilinta® (ticagrelor tablets) | 10,300,065 |
| Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 21-1118 (D. Del.) | 30-Jul-21 | Hon. Maryellen Noreika | Ingrezza® (valbenazine capsules) | 10,065,952 10,844,058 10,851,103 10,851,104 10,857,137 10,857,148 10,874,648 10,906,902 10,906,903 10,912,771 10,919,892 10,940,141 10,952,997 |
| Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Inc., 21-14428 (D.N.J.) | 30-Jul-21 | Hon. Michael A. Shipp | Rydapt® (midostaurin capsules) | 7,973,031 |
| Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 21-14447 (D.N.J.) | 30-Jul-21 | Hon. Kevin McNulty | Ingrezza® (valbenazine capsules) | 10,065,952 10,844,058 10,851,103 10,851,104 10,857,137 10,857,148 10,874,648 10,906,902 10,906,903 10,912,771 10,919,892 10,940,141 10,952,997 |
| Duchesnay Inc. v. Hetero Labs Ltd., 21-1130 (D. Del.) | Aug. 3, 2021 | Hon. Leonard P. Stark | Osphena® (ospemifene tablets) | 6,245,819 8,236,861 |
| Jazz Pharms., Inc. v. Avadel Pharms., plc, 21-1138 (D. Del.) | Aug. 4, 2021 | Hon. Maryellen Noreika | Xyrem® (sodium oxybate oral solution) | 11,077,079 |
| Astellas Pharma Inc. v. Apotex Inc., 21-1141 (D. Del.) | Aug. 5, 2021 | Hon. Joseph F. Bataillon | Myrbetriq® (mirabegron extended-release tablets) | 10,842,780 |
| Janssen Products, L.P. v. MSN Pharms. Inc., 21-14622 (D.N.J.) | Aug. 5, 2021 | Hon. Zahid N. Quraishi | Yondelis® (trabectedin for injection) | 8,895,557 7,420,051 |
| Neurocrine Biosciences, Inc. v. Teva Pharms., Inc., 21-1148 (D. Del.) | Aug. 6, 2021 | Hon. Maryellen Noreika | Ingrezza® (valbenazine capsules) | 10,993,941 |
| Vyne Therapeutics Inc. v. Padagis Israel Pharms. Ltd., 21-1152 (D. Del.) | Aug. 9, 2021 | Hon. Colm F. Connolly | Amzeeq® (minocycline topical foam) | 8,865,139 8,945,516 8,992,896 9,675,700 10,086,080 10,137,200 10,213,512 10,265,404 10,517,882 10,821,187 10,398,641 10,849,847 |
| Janssen Pharms., Inc. v. Mylan Labs. Ltd., 21-15137 (D.N.J.) | Aug. 11, 2021 | Hon. Zahid N. Quraishi | Invega Trinza® (paliperidone palmitate injection) | 10,143,693 |
| Merck Sharp & Dohme Corp. v. MSN Pharms. Inc., 21-1172 (D. Del.) | Aug. 12, 2021 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate) Janumet® (metformin HCl / sitagliptin phosphate) | 7,326,708 |
| Merck Sharp & Dohme Corp. v. Laurus Labs Ltd., 21-1173 (D. Del.) | Aug. 12, 2021 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate) | 7,326,708 |
| Pfizer Inc. v. Natco Pharma, Inc., 21-1179 (D. Del.) | Aug. 16, 2021 | Hon. Colm F. Connolly | Ibrance® (palbociclib tablets) | RE47,739 10,723,730 |
| Biomarin Pharm. Inc. v. Teva Pharms., Inc., 21-15392 (D.N.J.) | Aug. 16, 2021 | Hon. Esther Salas | Kuvan® (sapropterin dihydrochloride tablets) | 7,566,462 7,566,714 7,612,073 7,727,987 8,003,126 8,067,416 RE43,797 8,318,745 9,433,624 |
| Nexus Pharms., Inc. v. Nevakar, Inc., 21-15524 (D.N.J.) | Aug. 17, 2021 | Hon. Renee Marie Bumb | Emerphed® (ephedrine sulfate injection) | 11,090,278 10,869,845 |
| Baxter Healthcare Corp. v. Par Sterile Products, LLC, 21-1184 (D. Del.) | Aug. 18, 2021 | Hon. Unassigned | Norepinephrine bitartrate in 5% dextrose injection | 10,159,657 10,226,436 10,420,735 10,471,026 10,568,850 10,646,458 |
| Endo Ventures Ltd. v. Baxter Healthcare Corp., 21-1186 (D. Del.) | Aug. 18, 2021 | Hon. Unassigned | Norepinephrine bitartrate in 5% dextrose injection | 10,226,436 10,420,735 10,471,026 10,568,850 10,646,458 |
| Tolmar Therapeutics, Inc. v. Foresee Pharms. Co., Ltd., 21-15782 (D.N.J.) | Aug. 20, 2021 | Hon. Julien Xavier Neals | Camcevi® (leuprolide for injection) | 8,470,359 |
| UCB Inc. v. Cipla Ltd., 21-1229 (D. Del.) | Aug. 26, 2021 | Hon. Colm F. Connolly | Nayzilam® (midazolam nasal spray) | 8,217,033 8,809,322 9,289,432 9,687,495 |
| Zogenix, Inc. v. Apotex Inc., 21-1252 (D. Del.) | Aug. 30, 2021 | Hon. Colm F. Connolly | Fintepla® (fenfluramine oral solution) | 10,603,290 10,452,815 |
| Eagle Pharms., Inc. v. Slayback Pharma LLC, 21-1256 (D. Del.) | Aug. 31, 2021 | Hon. Colm F. Connolly | Belrapzo® (bendamustine HCl injection) | 11,103,483 |
| Astellas US LLC v. Aurobindo Pharma Ltd., 21-1269 (D. Del.) | Sept. 3, 2021 | Hon. Colm F. Connolly | Lexiscan® (regadenoson for injection) | 8,106,183 RE47,301 8,524,883 |
| Apotex Inc. v. Auspex Pharms., Inc., IPR2021-01507 (PTAB) | Sept. 8, 2021 | N/A | Austedo® (deutetrabenazine tablets) | 8,524,733 |
| AstraZeneca AB v. Changzhou Pharm. Factory, 21-1284 (D. Del.) | Sept. 10, 2021 | Hon. Richard G. Andrews | Brilinta® (ticagrelor tablets) | 8,425,934 |
| Supernus Pharms., Inc. v. Lupin Ltd., 21-1293 (D. Del.) | Sept. 10, 2021 | Hon. Maryellen Noreika | Trokendi XR® (topiramate extended-release capsules) | 8,298,576 8,298,580 8,663,683 8,877,248 8,889,191 8,992,989 9,549,940 9,555,004 9,622,983 10,314,790 |
| Bausch & Lomb, Inc. v. Slayback Pharma LLC, 21-16766 (D.N.J.) | Sept. 10, 2021 | Hon. Michael A. Shipp | Lumify® (brimonidine tartrate ophthalmic solution) | 8,293,742 9,259,425 |
| Supernus Pharms., Inc. v. Zydus Pharms. (USA) Inc., 21-17104 (D.N.J.) | Sept. 17, 2021 | Hon. Freda L. Wolfson | Trokendi XR® (topiramate extended-release capsules) | 8,298,576 8,298,580 8,663,683 8,877,248 8,889,191 8,992,989 9,549,940 9,555,004 9,622,983 10,314,790 |
| Supernus Pharms., Inc. v. Zydus Pharms. (USA) Inc., 21-7795 (S.D.N.Y.) | Sept. 17, 2021 | Hon. Jed S. Rakoff | Trokendi XR® (topiramate extended-release capsules) | 8,298,576 8,298,580 8,663,683 8,877,248 8,889,191 8,992,989 9,549,940 9,555,004 9,622,983 10,314,790 |
| Novartis Pharms. Corp. v. Alkem Labs. Ltd., 21-1330 (D. Del.) | Sept. 20, 2021 | Hon. Leonard P. Stark | Entresto® (sacubitril / valsartan tablets) | 11,096,918 |
| Puma Biotechnology, Inc. v. AstraZeneca Pharms. LP, 21-1338 (D. Del.) | Sept. 22, 2021 | Hon. Colm F. Connolly | Tagrisso® (osimertinib tablets) | 10,603,314 10,596,162 |
| Almirall, LLC v. Aleor Dermaceuticals Ltd., 21-17449 (D.N.J.) | Sept. 23, 2021 | Hon. Madeline Cox Arleo | Aczone® (dapsone gel) | 9,517,219 |
| Novartis Pharms. Corp. v. Crystal Pharm. (Suzhou) Co., Ltd., 21-1347 (D. Del.) | Sept. 24, 2021 | Hon. Leonard P. Stark | Entresto® (sacubitril / valsartan tablets) | 9,517,226 9,937,143 |
| Anacor Pharms., Inc. v. Alkem Labs. Ltd., 21-1348 (D. Del.) | Sept. 24, 2021 | Hon. Colm F. Connolly | Eucrisa® (crisaborole ointment) | 8,039,451 8,168,614 8,501,712 9,682,092 |
| Anacor Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 21-1349 (D. Del.) | Sept. 24, 2021 | Hon. Colm F. Connolly | Eucrisa® (crisaborole ointment) | 8,039,451 8,168,614 8,501,712 9,682,092 |
| Anacor Pharms., Inc. v. Macleods Pharms. Ltd., 21-1350 (D. Del.) | Sept. 24, 2021 | Hon. Colm F. Connolly | Eucrisa® (crisaborole ointment) | 8,039,451 8,168,614 8,501,712 9,682,092 |
| Anacor Pharms., Inc. v. Padagis Israel Pharms. Ltd., 21-1351 (D. Del.) | Sept. 24, 2021 | Hon. Colm F. Connolly | Eucrisa® (crisaborole ointment) | 8,168,614 8,501,712 9,682,092 |
| Anacor Pharms., Inc. v. Teva Pharms. Development, Inc., 21-1353 (D. Del.) | Sept. 24, 2021 | Hon. Colm F. Connolly | Eucrisa® (crisaborole ointment) | 8,168,614 8,501,712 9,682,092 |
| Medicure Int’l, Inc. v. Aurobindo Pharma Ltd., 21-17534 (D.N.J.) | Sept. 24, 2021 | Hon. Kevin McNulty | Aggrastat® (tirofiban HCl injection) | 6,770,660 |
| Pfizer Inc. v. Apotex Inc., 21-1402 (D. Del.) | Sept. 30, 2021 | Hon. Colm F. Connolly | Chantix® (varenicline tartrate tablets) | 6,890,927 7,265,119 |
| Anacor Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 21-17831 (D.N.J.) | Sept. 30, 2021 | Hon. Freda L. Wolfson | Eucrisa® (crisaborole ointment) | 8,039,451 8,168,614 8,501,712 9,682,092 |
| Bristol-Myers Squibb Co. v. Alembic Global Holding SA, 21-17926 (D.N.J.) | Sept. 30, 2021 | Hon. Kevin McNulty | Sprycel® (dasatinib tablets) | 7,491,725 8,680,103 |
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