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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). |
|---|---|---|---|---|
| Novo Nordisk Inc. v. Sun Pharm. Indus. Ltd., 22-0896 (D. Del.) | July 1, 2022 | Hon. Colm F. Connolly | Saxenda® (liraglutide recombinant solution injection) | 7,762,994 8,114,833 8,579,869 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 9,968,659 10,220,155 10,357,616 10,376,652 11,097,063 11,311,679 RE 46,363 |
| Novo Nordisk Inc. v. Sun Pharm. Indus. Ltd., 22-0897 (D. Del.) | July 1, 2022 | Hon. Colm F. Connolly | Victoza® (liraglutide recombinant solution injection) | 7,762,994 8,114,833 8,579,869 9,265,893 |
| AstraZeneca AB v. USV Private Ltd., 22-0899 (D. Del.) | July 1, 2022 | Hon. Richard G. Andrews | Brilinta® (ticagrelor tablets) | 10,300,065 |
| Supernus Pharms., Inc. v. Alkem Labs. Ltd., 22-3511 (N.D. Ill.) | July 6, 2022 | Hon. Elaine E. Bucklo | 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 |
| Veloxis Pharms., Inc. v. Accord Healthcare, Inc., 22-0909 (D. Del.) | July 7, 2022 | Hon. Maryellen Noreika | Envarsus XR® (tacrolimus extended-release tablets) | 8,685,998 9,549,918 10,166,190 10,864,199 11,110,081 11,123,331 |
| Takeda Pharms. U.S.A., Inc. v. Sun Pharm. Indus. Ltd., 22-0911 (D. Del.) | July 7, 2022 | Hon. Richard G. Andrews | Mydayis® (mixed salts of a single-entity amphetamine product extended-release capsules) | 8,846,100 9,173,857 |
| Purdue Pharma L.P. v. Accord Healthcare Inc., 22-0913 (D. Del.) | July 8, 2022 | Hon. Richard G. Andrews | OxyContin® (oxycodone HCl extended-release tablets) | 11,304,908 11,304,909 |
| Astellas Pharma Inc. v. Zydus Pharms. (USA) Inc., 22-4499 (D.N.J.) | July 8, 2022 | Hon. John Michael Vazquez | Xtandi® (enzalutamide tablets) | 7,709,517 |
| Duchesnay Inc. v. Alkem Labs. Ltd., 22-0917 (D. Del.) | July 11, 2022 | Hon. Colm F. Connolly | Bonjesta® (doxylamine succinate / pyridoxine HCl extended-release tablets) | 9,089,489 9,375,404 9,526,703 9,937,132 |
| Novo Nordisk Inc. v. Biocon Pharma Ltd., 22-0936 (D. Del.) | July 14, 2022 | Hon. Colm F. Connolly | Victoza® (liraglutide recombinant solution injection) | 7,762,994 8,114,833 9,265,893 |
| Novo Nordisk Inc. v. Biocon Pharma Ltd., 22-0937 (D. Del.) | July 14, 2022 | Hon. Colm F. Connolly | Saxenda® (liraglutide recombinant solution injection) | 7,762,994 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 9,968,659 10,220,155 10,357,616 10,376,652 11,097,063 11,311,679 RE 46,363 |
| Azurity Pharms., Inc. v. Alkem Labs. Ltd., 22-0940 (D. Del.) | July 15, 2022 | Hon. Maryellen Noreika | Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets) | 7,157,584 7,572,920 9,066,936 9,169,238 9,387,249 |
| Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, 22-0941 (D. Del.) | July 15, 2022 | Hon. Maryellen Noreika | Xyrem® (sodium oxybate oral solution) | 8,731,963 |
| Horizon Medicines LLC v. Aleor Dermaceuticals Ltd., 22-0944 (D. Del.) | July 18, 2022 | Vacant Judgeship (2022) | Pennsaid® 2% (diclofenac sodium topical solution) | 9,066,913 |
| Exelixix, Inc. v. MSN Labs. Private Ltd., 22-0945 (D. Del.) | July 18, 2022 | Hon. Richard G. Andrews | Cabometyx® (cabozantinib tablets) | 11,298,349 |
| Helsinn Healthcare S.A. v. Gland Pharma Ltd., 22-4635 (D.N.J.) | July 18, 2022 | Hon. Zahid N. Quraishi | Akynzeo® (fosnetupitant chloride HCl / palonosetron HCl injection) | 8,426,450 8,895,586 9,186,357 9,403,772 9,908,907 10,208,073 10,624,911 10,717,721 10,828,297 11,312,698 |
| Horizon Therapeutics, LLC v. Taro Pharm. Indus. Ltd., 22-4663 (D.N.J.) | July 20, 2022 | Hon. Christine P. O’Hearn | Ravicti® (glycerol phenylbutyrate oral liquid) | 8,642,012 9,254,278 9,326,966 9,561,197 9,962,359 9,999,608 10,045,958 10,045,959 10,183,002 10,183,003 10,183,004 10,183,005 10,183,006 10,668,040 |
| Bausch Health Ireland Ltd. v. Taro Pharms. Inc., 22-4670 (D.N.J.) | July 21, 2022 | Hon. Stanley R. Chesler | Duobrii® (halobetasol propionate / tazarotene lotion) | 8,809,307 10,478,502 10,251,895 10,426,787 |
| Neurocrine Biosciences, Inc. v. Teva Pharms., Inc., 22-0965 (D. Del.) | July 22, 2022 | Hon. Maryellen Noreika | Ingrezza® (valbenazine capsules) | 11,311,532 |
| Vertex Pharms. Inc. v. Lupin Ltd., 22-0966 (D. Del.) | July 22, 2022 | Hon. Richard G. Andrews | Kalydeco® (ivacaftor oral granules) | 8,883,206 10,272,046 10,646,481 11,147,770 |
| Supernus Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 22-4705 (D.N.J.) | July 22 2022 | Hon. Georgette Castner | 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 Health Ireland Ltd. v. Taro Pharms. Inc., 22-6225 (S.D.N.Y.) | July 22, 2022 | Hon. John P. Cronan | Duobrii® (halobetasol propionate / tazarotene lotion) | 8,809,307 10,478,502 10,251,895 10,426,787 |
| Covis Pharma Gmbh v. Eugia Pharma Specialties Ltd., 22-0971 (D. Del.) | July 25, 2022 | Hon. Kent A. Jordan | Makena® Auto-Injector (hydroxyprogesterone caproate) | 11,304,962 |
| Merck KGaA v. Accord Healthcare, Inc., 22-0974 (D. Del.) | July 25, 2022 | Hon. Gregory B. Williams | Mavenclad® (cladribine tablets) | 7,713,947 8,377,903 |
| Rigel Pharms., Inc. v. Annora Pharma Private Ltd., 22-4732 (D.N.J.) | July 25, 2022 | Hon. Evelyn Padin | Tavalisse® (fostamatinib disodium hexahydrate tablets) | 7,449,458 8,263,122 8,652,492 8,771,648 8,951,504 |
| Hope Medical Enterprises, Inc. v. Accord Healthcare, Inc., 22-0978 (D. Del.) | July 26, 2022 | Hon. Richard G. Andrews | sodium thiosulfate injection | 8,496,973 9,345,724 9,585,912 10,479,686 |
| Heron Therapeutics, Inc. v. Fresenius Kabi USA, LLC, 22-0985 (D. Del.) | July 27, 2022 | Hon. Colm F. Connolly | Cinvanti® (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 |
| Bayer Pharma AG v. Mylan Pharms. Inc., 22-0063 (N.D.W.V.) | Aug. 5, 2022 | Hon. John Preston Bailey | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Novartis Pharms. Corp. v. Ingenus Pharms., LLC, 22-1045 (D. Del.) | Aug. 9, 2022 | Hon. Maryellen Noreika | Xiidra® (lifitegrast ophthalmic solution) | 8,084,047 8,168,655 8,367,701 8,592,450 8,927,574 9,085,553 9,353,088 9,447,077 9,890,141 11,058,677 |
| ZS Pharma, Inc. v. Lupin Ltd., 22-1055 (D. Del.) | Aug. 10, 2022 | Hon. Gregory B. Williams | Lokelma® (sodium zirconium cyclosilicate oral suspension) | 8,802,152 8,808,750 8,877,255 9,592,253 9,844,567 9,861,658 9,913,860 10,300,087 10,335,432 10,398,730 10,413,569 10,695,365 |
| Neurocrine Biosciences, Inc. v. Lupin Ltd., 22-1061 (D. Del.) | Aug. 11, 2022 | Hon. Maryellen Noreika | Ingrezza® (valbenazine tosylate capsules) | 11,311,532 |
| Merck Sharp & Dohme LLC v. Prinston Pharm. Inc., 22-1070 (D. Del.) | Aug. 15, 2022 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) | 7,326,708 |
| Rigel Pharms., Inc. v. Servier Pharms. LLC, IPR2022-01423 | Aug. 15, 2022 | N/A | Idhifa® (enasidenib mesylate tablets) Tibsovo® (ivosidenib tablets) | 10,610,125 |
| ZS Pharma, Inc. v. Alkem Labs. Ltd., 22-1096 (D. Del.) | Aug. 22, 2022 | Hon. Gregory B. Williams | Lokelma® (sodium zirconium cyclosilicate oral suspension) | 8,877,255 9,592,253 9,913,860 10,300,087 10,695,365 |
| ZS Pharma, Inc. v. Ascent Pharms. Inc., 22-1099 (D. Del.) | Aug. 22, 2022 | Hon. Gregory B. Williams | Lokelma® (sodium zirconium cyclosilicate oral suspension) | 8,802,152 8,808,750 8,877,255 9,592,253 9,844,567 9,861,658 9,913,860 10,300,087 10,335,432 10,398,730 10,413,569 10,695,365 |
| ZS Pharma, Inc. v. Macleods Pharms. Ltd., 22-1100 (D. Del.) | Aug. 22, 2022 | Hon. Gregory B. Williams | Lokelma® (sodium zirconium cyclosilicate oral suspension) | 8,877,255 9,592,253 9,913,860 10,300,087 10,695,365 |
| ZS Pharma, Inc. v. Sandoz Inc., 22-1101 (D. Del.) | Aug. 22, 2022 | Hon. Gregory B. Williams | Lokelma® (sodium zirconium cyclosilicate oral suspension) | 8,802,152 8,808,750 8,877,255 9,592,253 9,844,567 9,861,658 9,913,860 10,300,087 10,335,432 10,398,730 10,413,569 10,695,365 |
| Boehringer Ingelheim Pharms. Inc. v. Dr. Reddy’s Labs. Ltd., 22-1102 (D. Del.) | Aug. 22, 2022 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) | 11,090,323 |
| Eli Lilly & Co. v. Aurobindo Pharma Ltd., 22-1114 (D. Del.) | Aug. 24, 2022 | Hon. Colm F. Connolly | Olumiant® (baricitinib tablets) | 8,158,616 8,420,629 |
| Eli Lilly & Co. v. MSN Labs. Private Ltd., 22-1115 (D. Del.) | Aug. 24, 2022 | Hon. Colm F. Connolly | Olumiant® (baricitinib tablets) | 8,158,616 8,420,629 |
| Neurocrine Biosciences, Inc. v. Sandoz Int’l GmbH, 22-1124 (D. Del.) | Aug. 26, 2022 | Hon. Maryellen Noreika | Ingrezza® (valbenazine tosylate capsules) | 8,039,627 8,357,697 11,311,532 |
| Otsuka Pharm. Co., Ltd. v. Mylan Labs. Ltd., 22-1125 (D. Del.) | Aug. 26, 2022 | Hon. Colm F. Connolly | Abilify Maintena® (aripiprazole extended-release injection) | 11,344,547 |
| Bausch Health Ireland Ltd. v. Mylan Pharms. Inc., 22-0085 (N.D.W.V.) | Sep. 1, 2022 | Hon. Thomas S. Kleeh | Trulance® (plecanatide tablets) | 11,142,549 11,319,346 |
| Galderma Labs., L.P. v. Prinston Pharm., Inc., 22-1166 (D. Del.) | Sep. 2, 2022 | Hon. Stephanie Bibas | Oracea® (doxycycline capsules) | 7,749,532 8,206,740 |
| Exelixis, Inc. v. Teva Pharm. Industries Ltd., 22-1168 (D. Del.) | Sep. 2, 2022 | Hon. Richard G. Andrews | Cabometyx® (cabozantinib tablets) | 11,298,349 |
| Merck Sharp & Dohme LLC v. Gland Pharma Ltd., 22-5461 (D.N.J.) | Sep. 8, 2022 | Hon. Julien Xavier Neals | Noxafil® (posaconazole injection) | 9,023,790 9,358,297 |
| Invagen Pharms., Inc. v. Bayer Pharma Aktiengesellschaft, IPR2022-01515 (PTAB) | Sep. 8, 2022 | N/A | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Bayer Intellectual Property GmbH v. USV Private Ltd., 22-5485 (D.N.J.) | Sep. 9, 2022 | Hon. Evelyn Padin | Xarelto® (rivaroxaban tablets) | 9,539,218 10,828,310 |
| Otsuka Pharm. Co., Ltd. v. Mylan Labs. Ltd., 22-0089 (N.D.W.V.) | Sep. 9, 2022 | Hon. Thomas S. Kleeh | Abilify Maintena® (aripiprazole extended-release injection) | 11,344,547 |
| Teva Pharms. USA, Inc. v. Bayer Pharma Aktiengesellschaft, IPR2022-01513 (PTAB) | Sep. 9, 2022 | N/A | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| BioDelivery Sciences International, Inc. v. Chemo Research, S.L., 22-1196 (D. Del.) | Sept. 12, 2022 | Hon. Colm F. Connolly | Belbuca® (buprenorphine buccal film) | 8,147,866 9,655,843 9,901,539 |
| AstraZeneca AB v. Annora Pharma Private Ltd., 22-1209 (D. Del.) | Sept. 15, 2022 | Hon. Richard G. Andrews | Brilinta® (ticagrelor tablets) | 10,300,065 |
| Eisai R&D Management Co., Ltd. v. Long Grove Pharms., LLC, 22-1211 (D. Del.) | Sept. 15, 2022 | Hon. Colm F. Connolly | Halaven® (eribulin mesylate injection) | RE 46,965 |
| Intercept Pharms., Inc. v. Zenara Pharma Private Ltd., 22-1215 (D. Del.) | Sept. 16, 2022 | Hon. Maryellen Noreika | Ocaliva® (obeticholic acid tablets) | 9,238,673 10,047,117 10,052,337 10,174,073 10,751,349 10,758,549 |
| AstraZeneca AB v. Alembic Pharms. Ltd., 22-1216 (D. Del.) | Sept. 16, 2022 | Hon. Richard G. Andrews | Brilinta® (ticagrelor tablets) | 10,300,065 |
| Salix Pharms., Inc. v. Zydus Pharms. (USA), Inc., 22-5589 (D.N.J.) | Sept. 16, 2022 | Hon. Julien Xavier Neals | Colazal® (balsalazide disodium capsules) | 7,452,872 7,625,884 8,497,256 |
| Bayer Intellectual Property GmbH v. Mankind Pharma Ltd., 22-5599 (D.N.J.) | Sept. 16, 2022 | Hon. Evelyn Padin | Xarelto® (rivaroxaban tablets) | 9,539,218 |
| Otsuka Pharm. Co., Ltd. v. Mylan Labs. Ltd., 22-1226 (D. Del.) | Sep. 20, 2022 | Hon. Colm F. Connolly | Abilify Maintena® (aripiprazole extended-release injection) | 11,400,087 |
| Radius Health, Inc. v. Orbicular Pharm. Techs. Pvt. Ltd., 22-11546 (D. Mass.) | Sep. 20, 2022 | Hon. Richard G. Stearns | Tymlos® (abaloparatide injection) | 7,803,770 8,148,333 8,748,382 10,996,208 11,255,842 |
| Vifor Fresenius Medical Care Renal Pharma Ltd. v. Teva Pharms. USA, Inc., 22-1227 (D. Del.) | Sep. 21, 2022 | Hon. Maryellen Noreika | Velphoro® (sucroferric oxyhydroxide chewable tablets) | 11,446,252 |
| Zogenix, Inc. v. Apotex Inc., 22-1232 (D. Del.) | Sep. 21, 2022 | Hon. Richard G. Andrews | Fintepla® (fenfluramine HCl oral solution) | 11,406,606 |
| Nexus Pharms., Inc. v. Exela Pharma Sciences, LLC, 22-1233 (D. Del.) | Sep. 21, 2022 | Hon. Gregory B. Williams | Akovaz® (ephedrine sulfate for injection) | 11,426,369 |
| Array Biopharma Inc. v. Eugia Pharma Specialities Ltd., 22-1236 (D. Del.) | Sep. 22, 2022 | Hon. Maryellen Noreika | Braftovi® (encorafenib capsules) | 9,474,754 |
| Gilead Sciences, Inc. v. Natco Pharma Ltd., 22-1259 (D. Del.) | Sep. 23, 2022 | Hon. Richard G. Andrews | Zydelig® (idelalisib tablets) | 9,492,449 |
| Nexus Pharms., Inc. v. Nevakar, Inc., 22-5683 (D.N.J.) | Sept. 23, 2022 | Hon. Renee Marie Bumb | Emerphed® (ephedrine sulfate for injection) | 11,426,369 |
| Otsuka Pharm. Co., Ltd. v. Zenara Pharma Pvt. Ltd., 22-1269 (D. Del.) | Sep. 27, 2022 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 RE 48,059 8,349,840 8,618,109 9,839,637 10,307,419 |
| Bial-Portela & Ca S.A. v. Aurobindo Pharma Ltd., 22-1270 (D. Del.) | Sep. 27, 2022 | Hon. Colm F. Connolly | Aptiom® (eslicarbazepine acetate tablets) | 11,364,247 |
| Array Biopharma Inc. v. Alembic Pharms. Ltd., 22-1277 (D. Del.) | Sep. 28, 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 |
| Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA), Inc., 22-1291 (D. Del.) | Sep. 30, 2022 | Hon. Maryellen Noreika | Ingrezza® (valbenazine capsules) | 11,311,532 |
| Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA), Inc., 22-5830 (D.N.J.) | Sep. 30, 2022 | Hon. Zahid N. Quraishi | Ingrezza® (valbenazine capsules) | 11,311,532 |
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