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New ANDA Cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Fall 2020
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). |
|---|---|---|---|---|
| Avion Pharms., LLC v. Granules Pharms., Inc., 20-0898 (D. Del.) | July 1, 2020 | Hon. Leonard P. Stark | Gloperba® (colchicine oral solution) |
9,907,751 10,226,423 |
| Horizon Medicines LLC v. Teva Pharms. USA, Inc., 20-8188 (D.N.J.) | July 2, 2020 | Hon. John M. Vazquez | Duexis® (ibuprofen / famotidine tablets) |
8,067,033 8,067,451 8,309,127 8,318,202 8,449,910 8,501,228 |
| Vifor Fresenius Medical Care Renal Pharma Ltd. v. Lupin Atlantis Holdings SA, 20-0911 (D. Del.) | July 6, 2020 | Hon. Maryellen Noreika | Velphoro® (sucroferric oxyhydroxide chewable tablets) |
10,682,376 10,695,367 |
| Arbor Pharms., LLC v. Lupin Ltd., 20-0922 (D. Del.) | July 8, 2020 | Hon. Maryellen Noreika | Edarbi® (azilsartan medoxomil tablets) | 7,157,584 7,572,920 9,066,936 |
| Allergan, Inc. v. Gland Pharma Ltd., 20-0932 (D. Del.) | July 9, 2020 | Hon. Colm F. Connolly | Lastacaft® (alcaftadine ophthalmic solution) | 8,664,215 10,617,695 |
| Celgene Corp. v. Lupin Ltd., 20-8570 (D.N.J.) | July 9, 2020 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,465,800 7,855,217 7,968,569 8,530,498 8,648,095 9,101,621 9,101,622 |
| Allergan, Inc. v. Gland Pharma Ltd., 20-4094 (N.D. Ill.) | July 10, 2020 | Hon. Joan B. Gottschall | Lastacaft® (alcaftadine ophthalmic solution) | 8,664,215 10,617,695 |
| TherapeuticsMD, Inc. v. Teva Pharms. USA, Inc., 20-8809 (D.N.J.) | July 13, 2020 | Hon. Brian R. Martinotti | Imvexxy® (estradiol vaginal inserts) |
10,537,581 |
| Amarin Pharma, Inc. v. Hikma Pharms. USA, Inc., 20-0421 (D. Nev) | July 13, 2020 | Hon. Miranda M. Du | Vascepa® (icosapent ethyl capsules) |
8,293,728 8,318,715 8,357,677 8,367,652 8,377,920 8,415,335 8,426,399 8,440,650 8,518,929 8,524,698 8,546,372 8,617,594 |
| Merck Sharp & Dohme Corp. v. Aurobindo Pharma Ltd., 20-0949 (D. Del.) | July 15, 2020 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) | 7,326,708 |
| Takeda Pharm. Co. Ltd. v. Norwich Pharms., Inc., 20-8966 (D.N.J.) | July 15, 2020 | Hon. Stanley R. Chesler | Vyvanse® (lisdexamfetamine dimesylate capsules) | 7,105,486 7,223,735 7,655,630 7,659,253 7,659,254 7,662,787 7,662,788 7,671,030 7,671,031 7,674,774 7,678,770 7,678,771 7,687,466 7,687,467 7,700,561 7,713,936 7,718,619 7,723,305 |
| Takeda Pharm. Co. Ltd. v. Norwich Pharms., Inc., 20-0953 (D. Del.) | July 16, 2020 | Hon. Leonard P. Stark | Vyvanse® (lisdexamfetamine dimesylate capsules) | 7,105,486 7,223,735 7,655,630 7,659,253 7,659,254 7,662,787 7,662,788 7,671,030 7,671,031 7,674,774 7,678,770 7,678,771 7,687,466 7,687,467 7,700,561 7,713,936 7,718,619 7,723,305 |
| Cephalon, Inc. v. Aurobindo Pharma, Ltd., 20-0962 (D. Del.) | July 17, 2020 | Hon. Colm F. Connolly | Treanda® (bendamustine HCL for injection) | 8,436,190 8,609,863 8,791,270 8,895,756 |
| AbbVie Inc. v. Dr. Reddy’s Labs., Ltd., 20-0968 (D. Del.) | July 21, 2020 | Hon. Leonard P. Stark | Venclexta® (venetoclax tablets) |
8,546,399 9,174,982 8,722,657 9,539,251 |
| Almirall, LLC v. Perrigo UK Finco Ltd. Partnership, 20-0975 (D. Del.) | July 22, 2020 | Hon. Gerald J. Pappert | Aczone® (dapsone gel) |
9,517,219 |
| ViiV Healthcare Co. v. Cipla Ltd., 20-0977 (D. Del.) | July 22, 2020 | Hon. Mitchell S. Goldberg | Juluca® (dolutegravir sodium / rilpivirine HCl tablets) | 9,242,986 10,426,780 |
| AbbVie Inc. v. Dr. Reddy’s Labs., Inc., 20-9292 (D.N.J.) | July 22, 2020 | Hon. Michael A. Shipp | Venclexta® (venetoclax tablets) |
8,546,399 9,174,982 8,722,657 9,539,251 |
| Pfizer Inc. v. Novo Nordisk A/S, IPR2020-01252 (PTAB) | July 22, 2020 | N/A | Victoza® (liraglutide recombinant for injection) Saxenda® (liraglutide recombinant for injection) Ozempic® (semaglutide for injection) | 8,114,833 |
| Janssen Products, L.P. v. Evenus Pharms. Labs. Inc., 20-9369 (D.N.J.) | July 23, 2020 | Hon. Freda L. Wolfson | Yondelis® (trabectedin for injection) | 8,895,557 |
| ACADIA Pharms. Inc. v. Aurobindo Pharma Ltd., 20-0985 (D. Del.) | July 24, 2020 | Hon. Richard G. Andrews | Nuplazid® (pimavanserin tartrate capsules) | 7,601,740 7,732,615 10,449,185 10,646,480 |
| ACADIA Pharms. Inc. v. Teva Pharms. USA, Inc., 20-0986 (D. Del.) | July 24, 2020 | Hon. Richard G. Andrews | Nuplazid® (pimavanserin tartrate capsules) | 7,601,740 7,732,615 10,449,185 10,646,480 |
| UCB, Inc. v. Annora Pharma Private Ltd., 20-0987 (D. Del.) | July 24, 2020 | Hon. Colm F. Connolly | Briviact® (brivaracetam tablets) |
6,784,197 6,911,461 8,492,416 |
| Vertex Pharms. Inc. v. Sun Pharm. Indus. Ltd., 20-0988 (D. Del.) | July 24, 2020 | Hon. Richard G. Andrews | Kalydeco® (ivacaftor tablets) |
10,646,481 |
| AbbVie Inc. v. Alembic Pharms. Ltd., 20-1009 (D. Del.) | July 28, 2020 | Hon. Leonard P. Stark | Venclexta® (venetoclax tablets) |
8,546,399 9,174,982 8,722,657 9,539,251 |
| ACADIA Pharms. Inc. v. Zydus Pharms. (USA) Inc., 20-1021 (D. Del.) | July 30, 2020 | Hon. Richard G. Andrews | Nuplazid® (pimavanserin tartrate capsules) | 7,601,740 7,732,615 10,517,860 10,449,185 10,646,480 |
| ACADIA Pharms. Inc. v. Hetero Labs Ltd., 20-1022 (D. Del.) | July 30, 2020 | Hon. Richard G. Andrews | Nuplazid® (pimavanserin tartrate capsules) | 7,601,740 10,449,185 10,646,480 |
| ACADIA Pharms. Inc. v. MSN Labs. Private Ltd., 20-1029 (D. Del.) | July 30, 2020 | Hon. Richard G. Andrews | Nuplazid® (pimavanserin tartrate capsules) | 7,732,615 10,646,480 |
| Teva Branded Pharm. Products R&D, Inc. v. Cipla Ltd., 20-10172 (D.N.J.) | Aug. 7, 2020 | Hon. Madeline Cox Arleo | Qvar® (beclomethasone dipropionate metered aerosol) | 9,463,289 9,808,587 10,022,509 10,022,510 10,086,156 10,561,808 |
| Allergan Pharms. Int’l Ltd. v. Sun Pharm. Indus. Ltd., 20-10176 (D.N.J.) | Aug. 7, 2020 | Hon. Susan D. Wigenton | Asacol® (mesalamine delayed-release tablets) | 9,089,492 |
| Biocon Pharma Ltd. v. Novartis Pharms. Corp., IPR2020-01263 (PTAB) | Aug. 7, 2020 | N/A | Entresto® (sacubitril / valsartan tablets)) | 8,101,659 |
| Horizon Orphan LLC v. Lupin Ltd., 20-10339 (D.N.J.) | Aug. 11, 2020 | Hon. Madeline Cox Arleo | Procysbi® (cysteamine bitartrate delayed-release capsules) |
8,026,284 9,192,590 9,198,882 9,925,156 9,925,157 9,925,158 9,173,851 9,233,077 10,143,665 10,328,037 10,548,859 |
| Bayer Intellectual Property GmbH v. Dr. Reddy’s Labs., Inc., 20-10378 (D.N.J.) | Aug. 12, 2020 | Hon. Madeline Cox Arleo | Xarelto® (rivaroxaban tablets) | 9,539,218 |
| Currax Pharms. LLC v. MSN Labs. Private Ltd., 20-1064 (D. Del.) | Aug. 13, 2020 | Hon. Richard G. Andrews | Silenor® (doxepin HCl tablets) | 7,915,307 9,532,971 9,572,814 9,907,780 10,548,871 10,653,660 |
| Merck Sharp & Dohme Corp. v. Aurobindo Pharma USA Inc., 20-10444 (D.N.J.) | Aug. 13, 2020 | Hon. Freda L. Wolfson | Noxafil® (posaconazole for injection) | 9,023,790 9,358,297 |
| Adamas Pharma, LLC v. Zydus Worlwide DMCC, 20-10463 (D.N.J.) | Aug. 13, 2020 | Hon. Brian R. Martinotti | Gocovri® (amantadine HCl extended-release capsules) | 8,389,578 8,796,337 8,889,740 8,895,614 8,895,615 8,895,616 8,895,617 8,895,618 8,741,343 9,867,791 9,867,792 9,867,793 9,877,933 10,154,971 10,646,456 |
| Azurity Pharms., Inc. v. Alkem Labs Ltd., 20-1094 (D. Del.) | Aug. 20, 2020 | Hon. Leonard P. Stark | Firvanq® (vancomycin HCl oral solution) | 10,493,028 |
| Merck Sharp & Dohme Corp. v. Aurobindo Pharma Ltd., 20-1099 (D. Del.) | Aug. 21, 2020 | Hon. Richard G. Andrews | Janumet® (metformin HCl / sitagliptin phosphate tablets) | 7,326,708 |
| Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., 20-1104 (D. Del.) | Aug. 21, 2020 | Hon. Colm F. Connolly | Hetlioz® (tasimelteon capsules) |
10,610,510 10,610,511 |
| Intercept Pharms., Inc. v. Apotex Inc., 20-1105 (D. Del.) | Aug. 21, 2020 | Hon. Maryellen Noreika | Ocaliva® (obeticholic acid tablets) |
9,238,673 10,047,117 10,052,337 10,174,073 |
| Bausch Health Ireland Ltd. v. Lupin Ltd., 20-11039 (D.N.J.) | Aug. 21, 2020 | Hon. Renee Marie Bumb | Plenvu® (polyethylene glycol / sodium ascorbate / sodium sulfate / ascorbic acid / sodium chloride / potassium chloride oral solution) | 10,646,512 |
| TherapeuticsMD, Inc. v. Teva Pharms. USA, Inc., 20-11087 (D.N.J.) | Aug. 21, 2020 | Hon. Brian M. Martinotti | Imvexxy® (estradiol vaginal inserts) | 10,668,082 |
| Assertio Therapeutics, Inc. v. Patrin Pharma, Inc., 20-5055 (N.D. Ill.) | Aug. 27, 2020 | Hon. Charles P. Kocoras | Cambia® (diclofenac potassium powder for oral solution) | 7,759,394 8,097,651 8,927,604 9,827,197 |
| Boehringer Ingelheim Pharms. Inc. v. Sun Pharm. Indus. Ltd., 20-1153 (D. Del.) | Aug. 28, 2020 | Hon. Colm F. Connolly | Trijardy XR® (empagliflozin / linagliptin / metformin extended-release tablets) | 8,551,957 9,155,705 9,415,016 9,949,998 10,022,379 10,258,637 10,406,172 10,596,120 |
| Intercept Pharms., Inc. v. Amneal Pharms. LLC, 20-1154 (D. Del.) | Aug. 28, 2020 | Hon. Maryellen Noreika | Ocaliva® (obeticholic acid tablets) | 9,238,673 10,047,117 10,052,337 10,174,073 |
| Intercept Pharms., Inc. v. Lupin Ltd., 20-1155 (D. Del.) | Aug. 28, 2020 | Hon. Maryellen Noreika | Ocaliva® (obeticholic acid tablets) |
7,138,390 9,238,673 10,047,117 10,052,337 10,174,073 |
| Bausch Health Ireland Ltd. v. Perrigo Israel Pharms. Ltd., 20-11807 (D.N.J.) | Aug. 28, 2020 | Hon. Stanley R. Chesler | Duobrii® (halobetasol propionate / tazarotene lotion) | 8,809,307 10,478,502 10,251,895 10,426,787 |
| Biogen MA Inc. v. Sun Pharm. Indus. Ltd., 20-1159 (D. Del.) | Aug. 31, 2020 | Hon. Maryellen Noreika | Tecfidera® (dimethyl fumarate delayed-release capsules) | 8,399,514 |
| AstraZeneca AB v. Macleods Pharms. Ltd., 20-1180 (D. Del.) | Sept. 3, 2020 | Hon. Richard G. Andrews | Brilinta® (ticagrelor tablets) |
10,300,065 |
| Astellas US LLC v. Meitheal Pharms., Inc., 20-1182 (D. Del.) | Sept. 4, 2020 | Hon. Colm F. Connolly | Lexiscan® (regadenoson for injection) |
8,106,183 RE47,301 8,524,883 |
| Fresenius Kabi USA, LLC v. Gland Pharma Ltd., 20-12347 (D. N.J.) | Sept. 4, 2020 | Hon. Freda L. Wolfson | Naropin® (ropivacaine HCl for injection) |
8,118,802 |
| Alkermes, Inc. v. Teva Pharm. Indus. Ltd., 20-12470 (D.N.J.) | Sept. 9, 2020 | Hon. Madeline Cox Arleo | Vivitrol® (extended-release naltrexone for injection) | 7,919,499 |
| Intercept Pharms., Inc. v. MSN Labs. Private Ltd., 20-1214 (D. Del.) | Sept. 10, 2020 | Hon. Maryellen Noreika | Ocaliva® (obeticholic acid tablets) | 7,138,390 9,238,673 10,047,117 10,052,337 10,174,073 |
| Intercept Pharms., Inc. v. Optimus Pharma Pvt. Ltd., 20-1215 (D. Del.) | Sept. 10, 2020 | Hon. Maryellen Noreika | Ocaliva® (obeticholic acid tablets) | 7,138,390 9,238,673 10,047,117 10,052,337 10,174,073 |
| Orexo AB v. Sun Pharm. Indus. Ltd., 20-12588 (D.N.J.) | Sept. 11, 2020 | Hon. Brian R. Martinotti | Zubsolv® (buprenorphine / naloxone sublingual tablets) | 8,470,361 8,658,198 8,940,330 9,259,421 9,439,900 |
| Merck Sharp & Dohme Corp. v. Unichem Labs. Ltd., 20-1227 (D. Del.) | Sept. 15, 2020 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) | 7,326,708 |
| Silvergate Pharms., Inc. v. Amneal Pharms. LLC, 20-1255 (D. Del.) | Sept. 18, 2020 | Hon. Leonard P. Stark | Epaned® (enalapril maleate oral solution) | 10,772,868 |
| Silvergate Pharms., Inc. v. Bionpharma Inc., 20-1256 (D. Del.) | Sept. 18, 2020 | Hon. Leonard P. Stark | Epaned® (enalapril maleate oral solution) | 10,772,868 |
| Kitov Pharma Ltd. v. Lupin Ltd., 20-12849 (D.N.J.) | Sept. 18, 2020 | Hon. Claire C. Cecchi | Consensi® (amlodipine besylate / celecoxib tablets) | 10,350,171 9,408,837 |
| Eton Pharms., Inc. v. Exela Pharma Sciences, LLC, PGR2020-00086 (PTAB) | Sept. 21, 2020 | N/A | Elcys® (cysteine HCl for injection) Nouress® (cysteine HCl for injection) | 10,653,719 |
| Janssen Pharms., Inc. v. Mylan Labs. Ltd., 20-13103 (D.N.J.) |
Sept. 23, 2020 | Hon. Brian R. Martinotti | Trinza® (paliperidone palmitate extended-release injectable suspension) | 10,143,693 |
| Otsuka Pharm. Co., Ltd. v. Alkem Labs. Ltd., 20-1286 (D. Del.) |
Sept. 24, 2020 | Hon. Leonard P. Stark | Rexulti® (brexipiprazole tablets) |
RE48,059 |
| Otsuka Pharm. Co., Ltd. v. Accord Healthcare Inc., 20-1287 (D. Del.) |
Sept. 24, 2020 | Hon. Leonard P. Stark | Rexulti® (brexipiprazole tablets) |
RE48,059 |
| Otsuka Pharm. Co., Ltd. v. Accord Healthcare Inc., 20-0878 (M.D.N.C.) |
Sept. 24, 2020 | Hon. Thomas D. Schroeder | Rexulti® (brexipiprazole tablets) |
RE48,059 |
| Otsuka Pharm. Co., Ltd. v. Unichem Labs. Ltd., 20-1295 (D. Del.) |
Sept. 25, 2020 | Hon. Leonard P. Stark | Rexulti® (brexipiprazole tablets) |
RE48,059 |
| Otsuka Pharm. Co., Ltd. v. Lupin Ltd., 20-1296 (D. Del.) |
Sept. 25, 2020 | Hon. Leonard P. Stark | Rexulti® (brexipiprazole tablets) |
RE48,059 |
| Otsuka Pharm. Co., Ltd. v. Amneal Pharms. LLC, 20-1297 (D. Del.) |
Sept. 25, 2020 | Hon. Leonard P. Stark | Rexulti® (brexipiprazole tablets) |
RE48,059 |
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