- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Entertainment and Media Litigation
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Fiduciary Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
May 13, 2024Robins Kaplan, Robert Bennett Recognized in Elite Trial Lawyers Awards
-
April 29, 2024Robins Kaplan Mourns Death of New York Associate Waleed Abbasi
-
April 29, 2024Robins Kaplan Secures $7.75 Million Verdict in Aerosol Dust Remover Abuse Case
-
May 20, 2024The Present and Future of DEI
-
May 23, 202414th Annual Disability Justice Seminar
-
June 10-11, 20242024 Probate and Trust Law Section Conference
-
May 2024Q&A with Anthony Froio
-
April 30, 2024A World Without Non-Competes: Protecting Confidential Information and Trade Secrets Following the FTC's Ban
-
First QuarterGENERICally Speaking: A Hatch-Waxman Litigation Bulletin
-
September 16, 2022Uber Company Systems Compromised by Widespread Cyber Hack
-
September 15, 2022US Averts Rail Workers Strike With Last-Minute Tentative Deal
-
September 14, 2022Hotter-Than-Expected August Inflation Prompts Massive Wall Street Selloff
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
Read our attorneys' take on the latest news and trends in the legal and business industries.
New ANDA Cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
First 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). |
---|---|---|---|---|
Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 24-0150 (D.N.J.) | Jan. 9, 2024 | Hon. Karen M. Williams | Yupelri® (revefenacin inhalation solution) | 11,858,898 |
Heron Therapeutics, Inc. v. Mylan Pharms. Inc., 24-0043 (D. Del.) | Jan. 11, 2024 | Hon. William C. Bryson | Aponvie® (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 11,744,800 |
Axsome Malta Ltd. v. Hetero USA Inc., 24-0196 (D.N.J.) | Jan. 11, 2024 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 11,771,666 11,771,667 11,779,554 11,793,776 |
Galderma Labs., L.P. v. Teva Pharms., Inc., 24-0197 (D.N.J.) | Jan. 11, 2024 | Hon. Michael A. Shipp | Aklief® (trifarotene cream) | 9,084,778 9,498,465 |
Novo Nordisk Inc. v. Mylan Pharms. Inc., 24-0050 (D. Del.) | Jan. 12, 2024 | Hon. Colm F. Connolly | Wegovy® (semaglutide injection) | 11,752,198 |
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 |
Eagle Pharms., Inc. v. Apotex Inc., 24-0064 (D. Del.) | Jan. 17, 2024 | Hon. Jennifer L. Hall | Belrapzo® (bendamustine HCl injection) | 11,844,783 11,872,214 |
Eagle Pharms., Inc. v. Slayback Pharma LLC, 24-0065 (D. Del.) | Jan. 17, 2024 | Hon. Jennifer L. Hall | Belrapzo® (bendamustine HCl injection) | 11,844,783 11,872,214 |
Eagle Pharms., Inc. v. Baxter Healthcare Corp., 24-0066 (D. Del.) | Jan. 17, 2024 | Hon. Jennifer L. Hall | Belrapzo® (bendamustine HCl injection) | 11,844,783 11,872,214 |
Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 24-0309 (D.N.J.) | Jan. 18, 2024 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 11,771,666 11,771,667 11,779,554 11,793,776 |
Novo Nordisk Inc. v. Rio Biopharms., Inc., 24-0330 (D.N.J.) | Jan. 19, 2024 | Hon. Renee Marie Bumb | Victoza® (liraglutide recombinant solution injection) | 8,114,833 9,265,893 |
Galderma Labs., L.P. v. Taro Pharms. Inc., 24-0333 (D.N.J.) | Jan. 19, 2024 | Hon. Michael A. Shipp | Aklief® (trifarotene cream) | 9,084,778 9,498,465 |
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. Granules India Ltd., 24-0081 (D. Del.) | Jan. 22, 2024 | Hon. Richard G. Andrews | Desyrel® (trazodone HCl tablets) | 8,133,893 |
Heron Therapeutics, Inc. v. Slayback Pharma LLC, 24-0423 (D.N.J.) | Jan. 24, 2024 | Hon. Jamel K. Semper | Cinvanti® (aprepitant injectable emulsion) | 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 11,744,800 |
Dr. Reddy’s Labs. S.A. v. Eye Therapies, LLC, IPR2024-00467 (PTAB) | Jan. 24, 2024 | N/A | Lumify® (brimonidine tartrate solution) | 11,833,245 |
Advanced Accelerator Applications USA, Inc. v. Lantheus Medical Imaging, Inc., 24-0095 (D. Del.) | Jan. 25, 2024 | Hon. Maryellen Noreika | Lutathera® (lutetium Lu 177 dotatate injection) | 10,596,276 |
Celgene Corp. v. Amneal Pharms. of NY, LLC, 24-0500 (D.N.J.) | Jan. 26, 2024 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,465,800 7,855,217 |
Bayer Pharma AG v. Lupin Ltd., 24-0138 (D. Del.) | Feb. 2, 2024 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
Eagle Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 24-0637 (D.N.J.) | Feb. 2, 2024 | Hon. Jamel K. Semper | Belrapzo® (bendamustine HCl injection) | 11,844,783 11,872,214 |
AstraZeneca Pharms. LP v. Sandoz Inc., 24-0641 (D.N.J.) | Feb. 2, 2024 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) | 7,449,464 8,475,842 8,859,562 11,633,396 |
AbbVie Inc. v. Hetero Labs Ltd., 24-0151 (D. Del.) | Feb. 5, 2024 | Hon. Jennifer L. Hall | Orilissa® (elagolix sodium tablets) | 11,690,845 11,690,854 |
AbbVie Inc. v. Prinston Pharm. Inc., 24-0152 (D. Del.) | Feb. 5, 2024 | Hon. Jennifer L. Hall | Orilissa® (elagolix sodium tablets) | 11,690,845 11,690,854 |
AbbVie Inc. v. Sun Pharm. Indus. Ltd., 24-0153 (D. Del.) | Feb. 5, 2024 | Hon. Jennifer L. Hall | Orilissa® (elagolix sodium tablets) | 11,690,845 11,690,854 |
AbbVie Inc. v. Zenara Pharma Private Ltd., 24-0154 (D. Del.) | Feb. 5, 2024 | Hon. Jennifer L. Hall | Orilissa® (elagolix sodium tablets) | 11,690,845 11,690,854 |
Novo Nordisk Inc. v. Rio Biopharmaceuticals, Inc., 24-0688 (D.N.J.) | Feb. 5, 2024 | Hon. Renee Marie Bumb | Saxenda® (liraglutide injection solution) | 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 10,220,155 10,357,616 10,376,652 11,097,063 11,311,679 11,446,443 RE46,363 |
Nexus Pharms., LLC v. Exela Pharma Sciences, LLC, PGR2024-00016 (PTAB) | Feb. 8, 2024 | N/A | Elcys® (cysteine HCl injection solution) | 11,642,370 |
UCB, Inc. v. Prinston Pharm. Inc., 24-0167 (D. Del.) | Feb. 8, 2024 | Hon. Colm F. Connolly | Briviact® (brivaracetam tablets) | 6,911,461 |
Axsome Malta Ltd. v. Sandoz Inc., 24-0860 (D.N.J.) | Feb. 14, 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 |
Eagle Pharms., Inc. v. Accord Healthcare Inc., 24-0095 (E.D.N.C.) | Feb. 16, 2024 | Hon. James C. Dever, III | Belrapzo® (bendamustine HCl injection) | 11,844,783 11,872,214 |
Teva Branded Pharm. Products R&D, Inc. v. Cipla USA, Inc., 24-0909 (D.N.J.) | Feb. 16, 2024 | Hon. Stanley R. Chesler | QVAR RediHaler® (beclomethasone dipropionate inhalation aerosol) | 8,132,712 8,931,476 10,022,509 10,022,510 10,086,156 10,561,808 10,695,512 10,792,447 11,395,888 11,395,889 11,559,637 11,583,643 |
Dr. Reddy’s Labs. S.A. v. Eye Therapies, LLC, IPR2024-00563 (PTAB) | Feb. 21, 2024 | N/A | Lumify® (brimonidine tartrate ophthalmic solution) | 11,596,600 |
American Regent, Inc. v. Somerset Therapeutics, LLC, 24-1022 (D.N.J.) | Feb. 22, 2024 | Hon. Brian R. Martinotti | Tralement® (trace elements injection 4*, USP) | 11,786,548 |
American Regent, Inc. v. Somerset Therapeutics, LLC, 24-1030 (D.N.J.) | Feb. 22, 2024 | Hon. Brian R. Martinotti | Multrys® (trace elements injection 4*, USP) | 11,786,548 |
American Regent, Inc. v. Somerset Therapeutics, LLC, 24-0248 (D Del.) | Feb. 23, 2024 | Hon. Maryellen Noreika | Tralement® (trace elements injection 4*, USP) | 11,786,548 |
American Regent, Inc. v. Somerset Therapeutics, LLC, 24-0249 (D. Del.) | Feb. 2324-, 2024 | Hon. Maryellen Noreika | Multrys® (trace elements injection 4*, USP) | 11,786,548 |
American Regent, Inc. v. RK Pharma, Inc., 24-1169 (D.N.J.) | Feb. 28, 2024 | Hon. Brian R. Martinotti | Tralement® (trace elements injection 4*, USP) Multrys® (trace elements injection 4*, USP) | 11,786,548 |
American Regent, Inc. v. RK Pharma, Inc., 24-0268 (D. Del.) | Feb. 29, 2024 | Hon. Maryellen Noreika | Tralement® (trace elements injection 4*, USP) Multrys® (trace elements injection 4*, USP) | 11,786,548 |
Apotex Inc. v. Novo Nordisk A/S, IPR2024-00631 (PTAB) | Mar. 1, 2024 | N/A | Ozempic® (semaglutide injection) | 10,335,462 |
Pfizer Inc. v. MSN Labs. Private Ltd., 24-0315 (D. Del.) | Mar. 8, 2024 | Hon. Jennifer L. Hall | Oxbryta® (voxelotor tablets) | 9,447,071 10,493,035 10,722,502 11,020,382 11,452,720 |
Pfizer Inc. v. Zydus Lifesciences Ltd., 24-0316 (D. Del.) | Mar. 8, 2024 | Hon. Jennifer L. Hall | Oxbryta® (voxelotor tablets) | 9,447,071 10,493,035 10,722,502 11,020,382 11,452,720 |
Beigene USA, Inc. v. MSN Pharms. Inc., 24-1971 (D.N.J.) | Mar. 8, 2024 | Hon. Zahid N. Quraishi | Brukinsa® (zanubrutinib capsules) | 10,927,117 11,591,340 11,786,531 11,851,437 |
Beigene USA, Inc. v. Sandoz Inc., 24-1972 (D.N.J.) | Mar. 8, 2024 | Hon. Zahid N. Quraishi | Brukinsa® (zanubrutinib capsules) | 10,927,117 11,591,340 |
American Regent, Inc. v. Apotex, Inc., 24-2268 (D.N.J.) | Mar. 11, 2024 | Hon. Brian R. Martinotti | Tralement® (trace elements injection 4*, USP) Multrys® (trace elements injection 4*, USP) | 11,786,548 |
America Regent, Inc. v. Apotex, Inc., 24-0327 (D. Del.) | Mar. 13, 2024 | Hon. Maryellen Noreika | Tralement® (trace elements injection 4*, USP) Multrys® (trace elements injection 4*, USP) | 11,786,548 |
Bayer Intellectual Property GmbH v. Prinston Pharm., Inc., 24-0336 (D. Del.) | Mar. 14, 2024 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 9,539,218 10,828,310 |
Merck Sharp & Dohme B.V. v. Hikma Pharms. USA Inc., 24-3206 (D.N.J.) | Mar. 15, 2024 | Hon. Claire C. Cecchi | Bridion® (sugammadex injection) | RE44,733 |
Actelion Pharms. Ltd. v. Torrent Pharms. Ltd., 24-3990 (D.N.J.) | Mar. 19, 2024 | Hon. Georgette Castner | Opsumit® (macitentan tablets) | 7,094,781 10,946,015 |
Axsome Malta Ltd. v. Hetero USA Inc., 24-3999 (D.N.J.) | Mar. 19, 2024 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 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 |
Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 24-4002 (D.N.J.) | Mar. 19, 2024 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 11,839,598 11,850,226 11,850,227 11,850,228 11,857,528 11,865,098 11,872,203 11,872,204 |
Arcutis Biotherapeutics, Inc. v. Padagis Israel Pharms. Ltd., 24-4231 (D.N.J.) | Mar. 26, 2024 | Hon. Edward S. Kiel | Zoryve® (roflumilast cream) | 9,884,050 9,907,788 10,940,142 11,129,818 11,793,796 11,819,496 |
Arcutis Biotherapeutics, Inc. v. Padagis Israel Pharms. Ltd., 24-0391 (D. Del.) | Mar. 27, 2024 | Hon. Colm F. Connolly | Zoryve® (roflumilast cream) | 9,884,050 9,907,788 10,940,142 11,129,818 11,793,796 11,819,496 |
Intra-Cellular Therapies, Inc. v. Aurobindo Pharma Ltd., 24-4264 (D.N.J.) | Mar. 27, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 9,956,227 10,695,345 10,960,009 11,026,951 11,690,842 11,753,419 11,806,348 RE48,839 |
Azurity Pharms., Inc. v. Hetero Labs Ltd., 24-0396 (D. Del.) | Mar. 28, 2024 | Hon. Maryellen Noreika | Edarbi® (azilsartan medoxomil tablets) | 9,066,936 |
Bayer Healthcare LLC v. Aurobindo Pharma Ltd., 24-0399 (D. Del.) | Mar. 28, 2024 | Hon. William C. Bryson | Children’s Astepro® Allergy OTC (azelastine HCl nasal spray) | 8,071,073 8,518,919 9,919,050 |
Intra-Cellular Therapies, Inc. v. Alkem Labs. Ltd., 24-4312 (D.N.J.) | Mar. 28, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 9,956,227 10,695,345 10,960,009 11,026,951 11,052,084 11,690,842 11,753,419 11,806,348 RE48,839 |
Intra-Cellular Therapies, Inc. v. Dr. Reddy’s Labs Inc., 24-4314 (D.N.J.) | Mar. 28, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 8,648,077 9,168,258 9,199,995 9,616,061 9,956,227 10,117,867 10,464,938 10,695,345 10,960,009 11,026,951 11,052,084 11,690,842 11,753,419 11,806,348 RE48,825 RE48,839 |
Intra-Cellular Therapies, Inc. v. Hetero USA, Inc., 24-4317 (D.N.J.) | Mar. 28, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 8,648,077 9,956,227 10,695,345 10,960,009 11,026,951 11,052,084 11,690,842 11,753,419 11,806,348 RE48,839 |
Intra-Cellular Therapies, Inc. v. MSN Labs. Private Ltd., 24-4325 (D.N.J.) | Mar. 28, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 9,956,227 10,695,345 10,960,009 11,026,951 11,052,084 11,690,842 11,753,419 11,806,348 RE48,839 |
Intra-Cellular Therapies, Inc. v. Sandoz Inc., 24-4327 (D.N.J.) | Mar. 28, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 8,648,077 9,168,258 9,199,995 9,616,061 9,956,227 10,117,867 10,464,938 10,695,345 10,960,009 11,026,951 11,052,084 11,690,842 11,753,419 11,806,348 RE48,825 RE48,839 |
Intra-Cellular Therapies, Inc. v. Zydus Pharms. (USA) Inc., 24-4330 (D.N.J.) | Mar. 28, 2024 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) | 10,695,345 11,052,084 11,690,842 11,753,419 11,806,348 |
Incyte Corp. v. Apotex Inc., 24-4366 (D.N.J.) | Mar. 28, 2024 | Hon. Christine P. O’Hearn | Jakafi® (ruxolitinib tablets) | 7,598,257 8,415,362 8,722,693 8,822,481 8,829,013 |
AbbVie Inc. v. Alembic Pharms. Ltd., 24-0405 (D. Del.) | Mar. 29, 2024 | Hon. Colm F. Connolly | Lastacaft® (alcaftadine ophthalmic solution) | 8,664,215 10,617,695 |
AbbVie Inc. v. Aurobindo Pharma U.S.A., Inc., 24-4403 (D.N.J.) | Mar. 29, 2024 | Hon. Zahid N. Quraishi | Ubrelvy® (Ubrogepant tablets) | 10,117,836 11,717,515 11,857,542 11,925,709 |
Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S., 24-4404 (D.N.J.) | Mar. 29, 2024 | Hon. Stanley R. Chesler | ProAir® HFA (albuterol sulfate inhalation aerosol) | 8,132,712 9,463,289 9,808,587 10,022,509 10,022,510 10,086,156 10,561,808 10,695,512 11,395,889 |
GENERICally Speaking Hatch Waxman Bulletin
GENERICally Speaking Hatch Waxman Bulletin
READ MORE Related Publications
First Quarter
GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Oren Langer, Christopher Pinahs, Emily Tremblay, and Christine May
March 25, 2024
Endo Ventures Unlimited Co. v. Nexus Pharms. Inc.
GENERICally Speaking Hatch Waxman Bulletin
March 22, 2024
Mallinckrodt plc v. Airgas Therapeutics LLC
GENERICally Speaking Hatch Waxman Bulletin
March 8, 2024
UCB, Inc. v. Mylan Techs. Inc.
GENERICally Speaking Hatch Waxman Bulletin
March 5, 2024
Genentech, Inc. v. Sandoz, Inc.
GENERICally Speaking Hatch Waxman Bulletin
Related News
October 14, 2022
September 9, 2022
Back to Top
Any information that you send us in an e-mail message should not be confidential or otherwise privileged information. Sending us an e-mail message will not make you a client of Robins Kaplan LLP. We do not accept representation until we have had an opportunity to evaluate your matter, including but not limited to an ethical evaluation of whether we are in a conflict position to represent you. Accordingly, the information you provide to us in an e-mail should not be information for which you would have an expectation of confidentiality.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.