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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). |
|---|---|---|---|---|
| UroGen Pharma Ltd. v. Teva Pharms., Inc., 24-0417 (D. Del.) | Apr. 2, 2024 | Hon. Colm F. Connolly | Jelmyto® (mitomycin for pyelocalyceal solution) | 9040074 9950069 |
| Novartis Pharms. Corp. v. Teva Pharms., Inc., 24-0428 (D. Del.) | Apr. 4, 2024 | Hon. Gregory B. Williams | Tasigna® (nilotinib HCl capsules) | 8,163,904 8,293,756 8,389,537 8,415,363 8,501,760 9,061,029 |
| Janssen Pharms., Inc. v. Macleods Pharms., Ltd., 24-4564 (D.N.J.) | Apr. 4, 2024 | Hon. Georgette Castner | Invokamet® (canagliflozin / metformin HCl tablets) | 11,576,894 |
| Horizon Therapeutics U.S. Holding LLC v. Teva Pharms., Inc., 24-0432 (D. Del.) | Apr. 5, 2024 | Hon. Gregory B. Williams | 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 |
| Actelion Pharms. Ltd. v. Gland Pharma Ltd., 24-0434 (D. Del.) | Apr. 5, 2024 | Hon. Jennifer L. Hall | Veletri® (epoprostenol sodium for injection) | 8,598,227 |
| 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 |
| AbbVie Inc. v. Zydus Pharms. (USA) Inc., 24-4603 (D.N.J.) | Apr. 5, 2024 | Hon. Zahid N. Quraishi | Ubrelvy® (ubrogepant tablets) | 10,117,836 11,717,515 11,857,542 11,925,709 |
| Salix Pharms., Inc. v. Amneal Pharms. of NY, LLC, 24-4607 (D.N.J.) | Apr. 5, 2024 | Hon. Edward S. Kiel | Xifaxan® (rifaximin tablets) | 11,779,571 11,564,912 10,456,384 8,193,196 8,518,94 8,741,90 9,271,968 10,703,763 |
| Axsome Malta Ltd. v. Alkem Labs. Ltd., 24-4608 (D.N.J.) | Apr. 5, 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 11,857,528 11,865,098 11,872,203 11,872,204 |
| Bausch Health Ireland Ltd. v. Mylan Pharms. Inc., 24-0036 (N.D.W.V.) | Apr. 5, 2024 | Hon. Thomas S. Kleeh | Trulance® (plecanatide tablets) | 11,834,521 |
| Chiesi Farmaceutici S.p.A v. Teva Pharms Inc., 24-0441 (D. Del.) | Apr. 8, 2024 | Hon. Colm F. Connolly | Mycapssa® (octreotide delayed-release capsules) | 8,329,198 8,535,695 9,265,812 9,566,246 10,238,709 10,695,397 11,052,126 11,141,457 11,338,011 11,510,963 11,857,595 11,890,316 |
| Abbvie Inc. v. MSN Pharms. Inc., 24-4662 (D.N.J.) | Apr. 8, 2024 | Hon. Zahid N. Quraishi | Ubrelvy® (ubrogepant tablets) | 10,117,836 11,717,515 11,857,542 11,925,709 |
| Vertex Pharms. Inc. v. Lupin Ltd., 24-0458 (D. Del.) | Apr. 11, 2024 | Hon. Richard G. Andrews | Kalydeco® (ivacaftor granules) | 8,883,206 10,272,046 10,646,481 11,147,770 11,564,916 11,752,106 |
| AstraZeneca AB v. Laurus Labs Ltd., 24-0459 (D. Del.) | Apr. 11, 2024 | Hon. Richard G. Andrews | Brilinta® (ticagrelor tablets) | 10,300,065 |
| AbbVie Inc. v. Hetero USA Inc., 24-4852 (D.N.J.) | Apr. 11, 2024 | Hon. Zahid N. Quraishi | Ubrelvy® (ubrogepant tablets) | 10,117,836 11,717,515 11,857,542 11,925,709 |
| Ipsen Biopharms., Inc. v. Conjupro Biotherapeutics, Inc., 24-4991 (D.N.J.) | Apr. 15, 2024 | Hon. Renee Marie Bumb | Onivyde® (irinotecan liposome injection) | 8,329,213 9,339,49 9,364,473 9,452,162 9,492,442 9,717,724 10,980,795 11,369,597 |
| Impax Labs., LLC v. Ascent Pharms. Inc., 24-5299 (D.N.J.) | Apr. 18, 2024 | Hon. Karen M. Williams | Rytary® (carbidopa / levodopa extended-release capsules) | 8,377,474 8,454,998 8,557,283 9,089,607 9,089,608 9,463,246 9,533,04 9,901,640 |
| Encube Ethicals Pvt. Ltd. v. Dermavant Sciences GmbH, IPR2024-00834 (PTAB) | Apr. 23, 2024 | N/A | Vtama® (tapinarof topical cream) | 11,590,088 |
| Fresenius Kabi USA, LLC v. Accord Healthcare Inc., 24-5674 (D.N.J.) | Apr. 26, 2024 | Hon. Susan D. Wigenton | levothyroxine sodium injection | 10,398,669 11,135,190 |
| Merck Sharp & Dohme LLC v. Azurity Pharms., Inc., 24-0545 (D. Del.) | 3-May-24 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate oral solution) | 7,326,708 |
| Viiv Healthcare Co. v. Hetero USA, Inc., 24-0547 (D. Del.) | 3-May-24 | Hon. Mitchell S. Goldberg | Tivicay® (dolutegravir sodium tablets) | 9,242,986 |
| Mitsubishi Tanabe Pharma Corp. v. Apotex Inc., 24-0549 (D. Del.) | 3-May-24 | Hon. Jennifer L. Hall | Radicava ORS® (edaravone oral suspension) | 10,987,341 11,241,416 11,478,450 11,826,352 |
| Eli Lilly & Co. v. Qilu Pharm. Co., Ltd., 24-5847 (D.N.J.) | 3-May-24 | Hon. Evelyn Padin | Reyvow® (lasmiditan tablets) | 11,053,214 |
| AstraZeneca AB v. Apotex Inc., 24-0551 (D. Del.) | 6-May-24 | Hon. Richard G. Andrews | Xigduo XR® (dapagliflozin / metformin HCl extended-release tablets) | 7,919,598 8,501,698 8,685,934 9,616,028 |
| Teva Branded Pharm. Products R&D, Inc. v. Cipla USA, Inc., 24-5856 (D.N.J.) | 6-May-24 | Hon. Stanley R. Chesler | QVAR RediHaler® (beclomethasone dipropionate inhalation aerosol) | 11,793,953 11,865,247 11,896,759 |
| AstraZeneca Pharms. LP v. Natco Pharma Ltd., 24-5887 (D.N.J.) | 7-May-24 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) | 11,970,530 11,975,001 |
| AstraZeneca Pharms. LP v. Sandoz Inc., 24-5889 (D.N.J.) | 7-May-24 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) | 11,970,530 11,975,001 |
| Neurelis, Inc. v. Padagis LLC, 24-0562 (D. Del.) | 8-May-24 | Hon. Maryellen Noreika | Valtoco® (diazepam nasal spray) | 8,895,546 11,241,414 11,793,786 |
| Esperion Therapeutics, Inc. v. Micro Labs USA, Inc., 24-5921 (D.N.J.) | 8-May-24 | Hon. Julien Xavier Neals | Nexletol® (bempedoic acid tablets) | 11,760,714 11,613,511 |
| Exelixis, Inc. v. Cipla, Ltd., 24-0565 (D. Del.) | 9-May-24 | Hon. Richard G. Andrews | Cabometyx® (cabozantinib (S)-malate tablets) | 8,877,776 11,091,439 11,091,440 11,098,015 11,298,349 |
| Breckenridge Pharm., Inc. v. Hetero USA Inc., 24-0571 (D. Del.) | 10-May-24 | Hon. Gregory B. Williams | Pradaxa® (dabigatran etexilate mesylate capsules) | 11,013,729 11,752,142 |
| Esperion Therapeutics, Inc. v. Renata Ltd., 24-6017 (D.N.J.) | 10-May-24 | Hon. Julien Xavier Neals | Nexletol® (bempedoic acid tablets) | 11,760,714 11,613,511 |
| Apotex Inc. v. Boehringer Ingelheim Pharms. Inc., 24-0577 (D. Del.) | 13-May-24 | Hon. Maryellen Noreika | Ofev® (nintedanib esylate capsules) | 9,907,756 10,105,323 |
| Grünenthal GmbH v. Teva Pharms., Inc., 24-6104 (D.N.J.) | 13-May-24 | Hon. Stanley R. Chesler | Nucynta® ER (tapentadol HCl extended-release tablets) | 11,344,512 |
| Acerta Pharma B.V. v. Cipla Ltd., 24-0587 (D. Del.) | 16-May-24 | Hon. Gregory B. Williams | Calquence® (acalabrutinib tablets) | 10,272,083 11,059,829 |
| Bayer Intellectual Property GmbH v. Ascent Pharms. Inc., 24-0588 (D. Del.) | 16-May-24 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 9,539,218 10,828,310 |
| Esperion Therapeutics, Inc. v. Accord Healthcare Inc., 24-6224 (D.N.J.) | 16-May-24 | Hon. Julien Xavier Neals | Nexletol® (bempedoic acid tablets) | 11,760,714 11,613,511 11,926,584 |
| Esperion Therapeutics, Inc. v. Alkem Labs. Ltd., 24-6263 (D.N.J.) | 17-May-24 | Hon. Julien Xavier Neals | Nexletol® (bempedoic acid tablets) Nexlizet® (bempedoic acid / ezetimibe tablets) | 11,760,714 11,613,511 10,912,751 11,744,816 |
| Pacira Pharms., Inc. v. eVenus Pharms. Labs. Inc., 24-6294 (D.N.J.) | 20-May-24 | Hon. Madeline Cox Arleo | Exparel® (bupivacaine liposome injectable suspension) | 11,819,574 11,819,575 |
| Melinta Therapeutics, LLC v. Nexus Pharms., Inc., 24-4180 (N.D. Ill.) | 21-May-24 | Hon. John F. Kness | Minocin® (minocycline for injection) | 11,944,634 |
| Purdue Pharma L.P. v. Accord Healthcare Inc., 24-0284 (E.D.N.C.) | 21-May-24 | Hon. Louise Wood Flanagan | OxyContin® (oxycodone HCl extended-release tablets) | 11,826,472 11,904,055 11,938,225 11,964,056 |
| Esperion Therapeutics, Inc. v. Aurobindo Pharma Ltd., 24-6348 (D.N.J.) | 22-May-24 | Hon. Julien Xavier Neals | Nexletol® (bempedoic acid tablets) | 11,760,714 11,613,511 |
| Pfizer Inc. v. Apotex Inc., 24-0621 (D. Del.) | 23-May-24 | Hon. Colm F. Connolly | Nurtec ODT® (rimegepant sulfate tablets) | 8,314,117 8,759,372 11,083,724 |
| Pfizer Inc. v. Aurobindo Pharma Ltd., 24-0622 (D. Del.) | 23-May-24 | Hon. Colm F. Connolly | Nurtec ODT® (rimegepant sulfate tablets) | 11,083,724 |
| Pfizer Inc. v. Changzhou Pharm. Factory, 24-0623 (D. Del.) | 23-May-24 | Hon. Colm F. Connolly | Nurtec ODT® (rimegepant sulfate tablets) | 8,314,117 8,759,372 11,083,724 |
| Pfizer Inc. v. MSN Labs. Private Ltd., 24-0624 (D. Del.) | 23-May-24 | Hon. Colm F. Connolly | Nurtec ODT® (rimegepant sulfate tablets) | 11,083,724 |
| Pfizer Inc. v. Natco Pharma Ltd., 24-0625 (D. Del.) | 23-May-24 | Hon. Colm F. Connolly | Nurtec ODT® (rimegepant sulfate tablets) | 11,083,724 |
| Pfizer Inc. v. Rubicon Research Private Ltd., 24-0626 (D. Del.) | 23-May-24 | Hon. Colm F. Connolly | Nurtec ODT® (rimegepant sulfate tablets) | 11,083,724 |
| Pfizer Inc. v. Teva Pharms., Inc., 24-0627 (D. Del.) | 23-May-24 | Hon. Colm F. Connolly | Nurtec ODT® (rimegepant sulfate tablets) | 11,083,724 |
| Esperion Therapeutics, Inc. v. MSN Pharms. Inc., 24-6386 (D.N.J.) | 23-May-24 | Hon. Julien Xavier Neals | Nexletol® (bempedoic acid tablets) | 11,760,714 11,613,511 |
| Esperion Therapeutics, Inc. v. Sandoz Inc., 24-6387 (D.N.J.) | 23-May-24 | Hon. Julien Xavier Neals | Nexletol® (bempedoic acid tablets) Nexlizet® (bempedoic acid / ezetimibe tablets) | 11,926,584 11,760,714 11,613,511 10,912,751 11,744,816 |
| Esperion Therapeutics, Inc. v. Hetero USA Inc., 24-6389 (D.N.J.) | 23-May-24 | Hon. Julien Xavier Neals | Nexletol® (bempedoic acid tablets) | 7,335,799 11,760,714 11,613,511 |
| Esperion Therapeutics, Inc. v. Dr. Reddy’s Labs. Inc., 24-6391 (D.N.J.) | 23-May-24 | Hon. Julien Xavier Neals | Nexletol® (bempedoic acid tablets) Nexlizet® (bempedoic acid / ezetimibe tablets) | 7,335,799 11,760,714 11,613,511 10,912,751 11,744,816 |
| GE Healthcare Ltd. v. Jubilant Draximage Inc., 24-6486 (D.N.J.) | 28-May-24 | Hon. Madeline Cox Arleo | Myoview™ (technetium Tc99m tetrofosmin for injection) | 9,549,999 |
| Axsome Therapeutics, Inc. v. Teva Pharms., Inc., 24-6489 (D.N.J.) | 28-May-24 | Hon. Michael E. Farbiarz | Auvelity® (dextromethorphan hydrobromide / bupropion HCl extended-release tablets) | 11,839,612 11,844,797 11,883,373 11,896,563 11,925,636 11,969,421 |
| Viiv Healthcare Co. v. Hetero USA, Inc., 24-0657 (D. Del.) | 3-Jun-24 | Hon. Mitchell S. Goldberg | Triumeq® (abacavir / dolutegravir / lamivudine tablets) | 9,242,986 |
| AbbVie Inc. v. Qilu Pharma, Inc., 24-6759 (D.N.J.) | 6-Jun-24 | Hon. Zahid N. Quraishi | Avycaz® (ceftazidime / avibactam for injection) | 8,471,025 8,835,455 8,969,566 9,284,314 9,695,122 |
| Eisai R&D Management Co., Ltd. v. Dr. Reddy’s Labs., Inc., 24-6765 (D.N.J.) | 6-Jun-24 | Hon. Christine P. O'Hearn | Lenvima® (lenvatinib mesylate capsules) | 7,612,208 10,407,393 11,186,547 |
| Aragon Pharms., Inc. v. Hetero Labs Ltd. Unit V, 24-6784 (D.N.J.) | 6-Jun-24 | Hon. Stanley R. Chesler | Erleada® (apalutamide tablets) | 8,802,689 9,388,159 9,987,261 |
| Vifor (Int’l) AG v. Dr. Reddy’s Labs., Ltd., 24-6833 (D.N.J.) | 7-Jun-24 | Hon. Georgette Castner | Injectafer® (ferric carboxymaltose injection) | 7,612,109 7,754,702 8,895,612 11,364,260 11,433,091 11,478,502 |
| Amicus Therapeutics US, LLC v. Aurobindo Pharma Ltd., 24-0698 (D. Del.) | 13-Jun-24 | Hon. Colm F. Connolly | Galafold® (migalastat capsules) | 11,833,164 |
| Amicus Therapeutics US, LLC v. Aurobindo Pharma Ltd., 24-0698 (D. Del.) | 13-Jun-24 | Hon. Colm F. Connolly | Galafold® (migalastat capsules) | 11,833,164 |
| AbbVie Inc. v. Fresenius Kabi USA, LLC, 24-4914 (N.D. Ill.) | 13-Jun-24 | Hon. John Robert Blakey | Avycaz® (ceftazidime / avibactam for injection) | 8,471,025 8,835,455 8,969,566 9,284,314 9,695,122 |
| Merck KGaA v. TWi Pharms., Inc., 24-0700 (D. Del.) | 14-Jun-24 | Hon. Maryellen Noreika | Mavenclad® (cladribine tablets) | 7,713,947 8,377,903 |
| Eisai R&D Management Co., Ltd. v. Torrent Pharms. Ltd., 24-7067 (D.N.J.) | 17-Jun-24 | Hon. Christine P. O’Hearn | Lenvima® (lenvatinib mesylate capsules) | 7,612,208 10,407,393 11,186,547 |
| SK Biopharms. Co., Ltd. v. Aurobindo Pharma Ltd., 24-0718 (D. Del.) | 18-Jun-24 | Hon. Jennifer L. Hall | Xcopri® (cenobamate tablets) | 7,598,279 11,654,133 |
| Janssen Pharms., Inc. v. Qilu Pharm. Co., Ltd., 24-7094 (D.N.J.) | 18-Jun-24 | Hon. Claire C. Cecchi | Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) | 9,439,906 |
| Theravance Biopharma R&D IP, LLC v. Qilu Pharm. Co., Ltd., 24-2689 (E.D. Pa.) | 18-Jun-24 | Hon. Kai N. Scott | Yupelri® (revefenacin inhalation solution) | 8,541,451 9,765,028 10,550,081 11,008,289 11,484,531 11,691,948 11,858,898 |
| Veloxis Pharms., Inc. v. Sun Pharm. Indus. Ltd., 24-0726 (D. Del.) | 19-Jun-24 | Hon. Joshua D. Wolson | Envarsus XR® (tacrolimus extended-release tablets) | 8,685,998 9,549,918 10,166,190 10,864,199 11,110,081 11,123,331 11,419,823 |
| Exeltis USA, Inc. v. Lupin Ltd., 24-0732 (D. Del.) | 20-Jun-24 | Hon. Richard G. Andrews | Slynd® (drospirenone tablets) | 11,951,213 |
| Salix Pharms., Inc. v. Norwich Pharms., Inc., 24-7140 (D.N.J.) | 20-Jun-24 | Hon. Robert Kirsch | Xifaxan® (rifaximin tablets) | 11,779,571 11,564,912 |
| Otsuka Pharm. Co., Ltd. v. Sun Pharm. Indus. Ltd., 24-0740 (D. Del.) | 21-Jun-24 | Hon. Richard G. Andrews | Jynarque® (tolvaptan tablets) | 8,501,730 10,905,694 8,273,735 |
| Teva Branded Pharm. Products R&D, Inc. v. Cipla USA, Inc., 24-7162 (D.N.J.) | 21-Jun-24 | Hon. Stanley R. Chesler | Qvar RediHaler® (beclomethasone dipropionate inhalation aerosol) | 11,957,832 |
| Bausch Health Ireland Ltd. v. MSN Labs. Private Ltd., 24-7182 (D.N.J.) | 21-Jun-24 | Hon. Stanley R. Chesler | Trulance® (plecanatide tablets) | 11,834,521 |
| Boehringer Ingelheim Pharms. Inc. v. Granules India Ltd., 24-0753 (D. Del.) | 25-Jun-24 | Hon. Colm F. Connolly | Tradjenta® (linagliptin tablets) | 9,486,526 10,034,877 |
| Pfizer Inc. v. Biocon Ltd., 24-0757 (D. Del.) | 26-Jun-24 | Hon. Colm F. Connolly | Xeljanz® XR (tofacitinib citrate extended-release tablets) | RE41,783 |
| AstraZeneca Pharms. LP v. Cipla Ltd., 24-7346 (D.N.J.) | 28-Jun-24 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) | 8,859,562 11,970,530 11,975,001 8,475,842 11,633,396 |
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