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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). |
|---|---|---|---|---|
| Ferring Pharms. Inc. v. Eugia Pharma Specialties Ltd., 22-0017 (D. Del.) | Jan. 4, 2022 | Hon. Maryellen Noreika | Firmagon® (degarelix for injection) | 9,579,359 10,729,739 10,973,870 9,415,085 10,695,398 8,841,081 9,877,999 8,828,938 |
| Novartis Pharms. Corp. v. Alkem Labs. Ltd., 22-0032 (D. Del.) | Jan. 7, 2022 | Hon. Leonard P. Stark | Entresto® (sacubitril / valsartan tablets) | 11,058,667 |
| Amgen Inc. v. Aurobindo Pharma Ltd., 22-0037 (D. Del.) | Jan. 10, 2022 | Hon. Maryellen Noreika | Parsabiv® (etelcalcetide injection) | 11,162,500 |
| Eagle Pharms., Inc. v. Celerity Pharms., LLC, 22-0042 (D. Del.) | Jan. 11, 2022 | Hon. Colm F. Connolly | Belrapzo® (bendamustine HCl for injection) | 11,103,483 |
| Arbor Pharms., LLC v. Alkem Labs. Ltd., 22-0143 (D.N.J.) | Jan. 11, 2022 | Hon. Karen M. Williams | Nymalize® (nimodipine oral solution) | 10,342,787 10,576,070 |
| Pfizer Inc. v. Synthon Pharms., Inc., 22-0045 (D. Del.) | Jan. 12, 2022 | Hon. Colm F. Connolly | Ibrance® (palbociclib tablets) | 11,065,250 |
| Nexus Pharms., Inc. v. Nephron SC, Inc., 22-0137 (D.S.C.) | Jan. 14, 2022 | Hon. Mary Geiger Lewis | Emerphed® (ephedrine sulfate for injection) | 11,090,278 |
| Novartis Pharms. Corp. v. Teva Pharms. USA, Inc., 22-0083 (D. Del.) | Jan. 21, 2022 | Hon. Leonard P. Stark | Entresto® (sacubitril / valsartan tablets) | 11,058,667 |
| Neurocrine Biosciences, Inc. v. Teva Pharms., Inc., 22-0092 (D. Del.) | Jan. 21, 2022 | Hon. Maryellen Noreika | Ingrezza® (valbenazine capsules) | 11,026,931 11,026,939 11,040,029 |
| Supernus Pharms., Inc. v. Apotex Inc., 22-0322 (D.N.J.) | Jan. 24, 2022 | Hon. Freda L. Wolfson | Oxtellar XR® (oxcarbazepine extended-release tablets) | 11,166,960 |
| Sanofi-Aventis U.S. LLC v. Aurobindo Pharma Ltd., 22-0141 (D. Del.) | Jan. 31, 2022 | Hon. Richard G. Andrews | Jevtana® Kit (cabazitaxel injection) | 10,583,110 10,716,777 8,927,592 |
| Acerta Pharma B.V. v. Alembic Pharms. Ltd., 22-0154 (D. Del.) | Feb. 2, 2022 | Hon. Richard G. Andrews | Calquence® (acalabrutinib capsules) | 9,758,524 10,239,883 9,796,721 10,167,291 10,272,083 |
| Acerta Pharma B.V. v. Natco Pharma Ltd., 22-0155 (D. Del.) | Feb. 2, 2022 | Hon. Richard G. Andrews | Calquence® (acalabrutinib capsules) | 9,290,504 9,758,524 10,239,883 9,796,721 10,167,291 10,272,083 |
| Bausch & Lomb, Inc. v. Lupin Ltd., 22-0534 (D.N.J.) | Feb. 2, 2022 | Hon. Michael A. Shipp | Lumify® (brimonidine tartrate ophthalmic solution) | 8,293,742 9,259,425 |
| Mylan Pharms. Inc. v. Bayer Pharma Aktiengesellschaft, IPR2022-00517 (PTAB) | Feb. 2, 2022 | N/A | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Dr. Reddy’s Labs., Inc. v. Genentech, Inc., PGR2022-00023 (PTAB) | Feb. 3, 2022 | N/A | Venclexta® (venetoclax tablets) | 10,993,942 |
| Pfizer Inc. v. Sun Pharm. Indus. Ltd., 22-0161 (D. Del.) | Feb. 4, 2022 | Hon. Colm F. Connolly | Ibrance® (palbociclib tablets) | 11,065,250 |
| Acerta Pharma B.V. v. Cipla Ltd., 22-0162 (D. Del.) | Feb. 4, 2022 | Hon. Richard G. Andrews | Calquence® (acalabrutinib capsules) | 9,758,524 10,239,883 9,796,721 10,167,291 10,272,083 |
| Acerta Pharma B.V. v. MSN Pharms. Inc., 22-0163 (D. Del.) | Feb. 4, 2022 | Hon. Richard G. Andrews | Calquence® (acalabrutinib capsules) | 9,290,504 9,758,524 10,239,883 9,796,721 10,167,291 10,272,083 |
| Acerta Pharma B.V. v. Sandoz Inc., 22-0164 (D. Del.) | Feb. 4, 2022 | Hon. Richard G. Andrews | Calquence® (acalabrutinib capsules) | 9,290,504 9,758,524 10,239,883 9,796,721 10,167,291 10,272,083 |
| Bayer Pharma AG v. Micro Labs Ltd., 22-0165 (D. Del.) | Feb. 4, 2022 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Allergan USA, Inc. v. MSN Labs. Private Ltd., 22-0181 (D. Del.) | Feb. 9, 2022 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 11,229,627 |
| Allergan USA, Inc. v. Sun Pharm. Indus. Ltd., 22-0182 (D. Del.) | Feb. 9, 2022 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 11,229,627 |
| Novartis Pharms. Corp. v. Laurus Labs Ltd., 22-0186 (D. Del.) | Feb. 10, 2022 | Hon. Leonard P. Stark | Entresto® (sacubitril / valsartan tablets) | 11,058,667 |
| Pacira Pharms., Inc. v. eVenus Pharms. Labs. Inc., 22-0718 (D.N.J.) | Feb. 10, 2022 | Hon. Madeline Cox Arleo | Exparel® (bupivacaine liposome injectable suspension) | 11,033,495 11,179,336 |
| Pfizer Inc. v. Slayback Pharma LLC, 22-0191 (D. Del.) | Feb. 11, 2022 | Hon. Leonard P. Stark | Xeljanz® (tofacitinib oral solution) | RE41,783 |
| Pfizer Inc. v. Teva Pharms. USA, Inc., 22-0192 (D. Del.) | Feb. 11, 2022 | Hon. Leonard P. Stark | Xeljanz® XR (tofacitinib extended-release tablets) | 10,639,309 |
| Astellas US LLC v. Curia Missouri, Inc., 22-0199 (D. Del.) | Feb. 14, 2022 | Hon. Colm F. Connolly | Lexiscan® (regadenoson for injection) | 6,403,567 |
| Pfizer Inc. v. Zydus Pharms. (USA) Inc., 22-0210 (D. Del.) | Feb. 16, 2022 | Hon. Colm F. Connolly | Ibrance® (palbociclib tablets) | 10,723,730 11,065,250 |
| Janssen Pharms., Inc. v. Accord Healthcare, Inc., 22-0856 (D.N.J.) | Feb. 16, 2022 | Hon. Claire C. Cecchi | Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) | 9,439,906 |
| Fresenius Kabi USA, LLC v. Sintetica S.A., 22-0217 (D. Del.) | Feb. 18, 2022 | Hon. Maryellen Noreika | Naropin® (ropivacaine HCl injection) | 8,118,802 |
| Boehringer Ingelheim Pharms. Inc. v. Laurus Labs Ltd., 22-0220 (D. Del.) | Feb. 18, 2022 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) | 11,090,323 |
| Otsuka Pharm. Co., Ltd. v. Teva Pharms. USA, Inc., 22-0221 (D. Del.) | Feb. 18, 2022 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 RE48,059 8,349,840 8,618,109 9,839,637 10,307,419 |
| AstraZeneca AB v. Taro Pharms. U.S.A., Inc., 22-0892 (D.N.J.) | Feb. 18, 2022 | Hon. Karen M. Williams | Brilinta® (ticagrelor tablets) | 10,300,065 |
| Pfizer Inc. v. Zydus Pharms. (USA) Inc., 22-0899 (D.N.J.) | Feb. 18, 2022 | Hon. Renee Marie Bumb | Ibrance® (palbociclib tablets) | 10,723,730 11,065,250 |
| AstraZeneca AB v. Taro Pharms. U.S.A., Inc., 22-1405 (S.D.N.Y.) | Feb. 18, 2022 | Hon. Vernon S. Broderick | Brilinta® (ticagrelor tablets) | 10,300,065 |
| Amgen Inc. v. Aurobindo Pharma Ltd., 22-0227 (D. Del.) | Feb. 22, 2022 | Hon. Maryellen Noreika | Parsabiv® (etelcalcetide injection) | 11,162,500 |
| Bausch Health Companies Inc. v. Gland Pharma Ltd., 22-0939 (D.N.J.) | Feb. 22, 2022 | Hon. Claire C. Cecchi | Relistor® (methylnaltrexone bromide injection) | 8,247,425 8,420,663 8,552,025 8,822,490 9,180,125 9,492,445 9,669,096 10,376,584 |
| Exelixis, Inc. v. MSN Labs. Private Ltd., 22-0228 (D. Del.) | Feb. 23, 2022 | Hon. Richard G. Andrews | Cabometyx® (cabozantinib (S)-malate tablets) | 11,091,439 11,091,440 11,098,015 |
| Bristol-Myers Squibb Co. v. Xspray Pharma AB, 22-0964 (D.N.J.) | Feb. 23, 2022 | Hon. Noel L. Hillman | Sprycel® (dasatinib tablets) | 7,491,725 8,680,103 |
| Sun Pharm. Indus. Ltd. v. Aurinia Pharms. Inc., IPR2022-00617 (PTAB) | Feb. 24, 2022 | N/A | Lupkynis® (voclosporin capsules) | 10,286,036 |
| Journey Medical Corp. v. Teva Pharms., Inc. 22-0288 (D. Del.) | Mar. 4, 2022 | Hon. Colm F. Connolly | Qbrexza® (glycopyrronium cloth) | 8,618,160 8,859,610 9,259,414 9,744,105 10,004,717 10,052,267 10,543,192 10,548,875 |
| Novo Nordisk Inc. v. Rio Biopharms. Inc., 22-0294 (D. Del.) | Mar. 4, 2022 | Hon. Colm F. Connolly | Ozempic® (semaglutide injection) | 8,129,343 9,132,239 9,457,154 9,687,611 10,335,462 |
| Novo Nordisk Inc. v. Aurobindo Pharma USA, Inc., 22-0295 (D. Del.) | Mar. 4, 2022 | Hon. Colm F. Connolly | Ozempic® (semaglutide injection) | 7,762,994 8,114,833 8,129,343 8,536,122 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 10,220,155 10,335,462 10,357,616 10,376,652 11,097,063 RE46,363 |
| Novo Nordisk Inc. v. Sun Pharm. Indus. Ltd., 22-0296 (D. Del.) | Mar. 4, 2022 | Hon. Colm F. Connolly | Ozempic® (semaglutide injection) | 9,132,239 10,335,462 |
| Novo Nordisk Inc. v. Zydus Worldwide DMCC., 22-0297 (D. Del.) | Mar. 4, 2022 | Hon. Colm F. Connolly | Ozempic® (semaglutide injection) | 9,132,239 10,335,462 |
| Novo Nordisk Inc. v. Dr. Reddy’s Labs., Ltd., 22-0298 (D. Del.) | Mar. 4, 2022 | Hon. Colm F. Connolly | Ozempic® (semaglutide injection) | 8,129,343 8,920,383 9,132,239 9,457,154 9,687,611 9,775,953 10,220,155 10,335,462 11,097,063 RE46,363 |
| Novo Nordisk Inc. v. Alvogen, Inc., 22-0299 (D. Del.) | Mar. 4, 2022 | Hon. Colm F. Connolly | Ozempic® (semaglutide injection) | 8,129,343 8,920,383 9,132,239 9,457,154 9,687,611 9,775,953 10,220,155 10,335,462 11,097,063 RE46,363 |
| Cipla Ltd. v. Boehringer Ingelheim Pharms. Inc., 22-0300 (D. Del.) | Mar. 4, 2022 | Hon. Maryellen Noreika | Ofev® (nintedanib capsules) | 9,907,756 10,105,323 10,154,990 6,762,180 7,119,093 |
| Otsuka Pharm. Co., Ltd. v. MSN Labs. Private Ltd., 22-0316 (D. Del.) | Mar. 10, 2022 | Hon. Richard G. Andrews | Samsca® (tolvaptan tablets) | 8,501,730 10,905,694 |
| Aerie Pharms., Inc. v. Gland Pharma Ltd., 22-1359 (D.N.J.) | Mar. 14, 2022 | Hon. Michael A. Shipp | Rhopressa® (netarsudil dimesylate ophthalmic solution) | 9,415,043 9,931,336 11,185,538 10,588,901 |
| Aerie Pharms., Inc. v. Orbicular Pharm. Technologies, 22-1364 (D.N.J.) | Mar. 14, 2022 | Hon. Michael A. Shipp | Rocklatan® (netarsudil / latanoprost ophthalmic solution) | 9,415,043 9,931,336 11,185,538 10,588,901 9,993,470 11,197,853 |
| Aerie Pharms., Inc. v. Micro Labs Ltd., 22-1365 (D.N.J.) | Mar. 14, 2022 | Hon. Michael A. Shipp | Rhopressa® (netarsudil ophthalmic solution) | 8,394,826 10,174,017 10,654,844 11,028,081 9,415,043 9,931,336 11,185,538 10,588,901 |
| Horizon Orphan LLC v. Teva Pharms., Inc., 22-1382 (D.N.J.) | Mar. 15, 2022 | Hon. Renee Marie Bumb | Procysbi® (cysteamine bitartrate delayed-release capsules) | 8,026,284 9,192,590 9,198,882 9,173,851 9,233,077 10,143,665 |
| Arbor Pharms., LLC v. Saba Ilac Sanayi ve Ticaret AS, 22-0353 (D. Del.) | Mar. 18, 2022 | Hon. Maryellen Noreika | Edarbi® (azilsartan medoxomil tablets) | 7,157,584 7,572,920 9,066,936 |
| AstraZeneca AB v. Alkem Labs. Ltd., 22-0354 (D. Del.) | Mar. 18, 2022 | Hon. Richard G. Andrews | Brilinta® (ticagrelor tablets) | RE46,276 10,300,065 |
| Novo Nordisk Inc. v. Mylan Pharms. Inc., 22-0023 (N.D.W.V.) | Mar. 18, 2022 | Hon. Irene M. Keeley | Ozempic® (semaglutide injection) | 8,114,833 8,129,343 8,536,122 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 10,355,462 10,357,616 10,376,652 11,097,063 RE46,363 |
| Mallinckrodt Pharms. Ireland Ltd. v. Zydus Pharms. (USA) Inc., 22-1592 (D.N.J.) | Mar. 21, 2022 | Hon. Claire C. Cecchi | Ofirmev® (acetaminophen injection) | 9,399,012 9,610,265 9,987,238 10,383,834 |
| Mylan Pharms. Inc. v. Bausch Health Ireland Ltd., IPR2022-00722 (PTAB) | Mar. 21, 2022 | N/A | Trulance® (plecanatide tablets) | 7,041,786 |
| Merck Sharp & Dohme Corp. v. Aurobindo Pharma Ltd., 22-0377 (D. Del.) | Mar. 23, 2022 | Hon. Richard G. Andrews | Steglatro® (ertugliflozin tablets) | 8,080,580 |
| Merck Sharp & Dohme Corp. v. Hetero Labs Ltd., 22-0378 (D. Del.) | Mar. 23, 2022 | Vacant Judgeship | Steglatro® (ertugliflozin tablets) | 8,080,580 |
| Merck Sharp & Dohme Corp. v. Zenara Pharma Private Ltd., 22-0379 (D. Del.) | Mar. 23, 2022 | Vacant Judgeship | Steglatro® (ertugliflozin tablets) | 8,080,580 |
| Amgen Inc. v. USV Private Ltd., 22-0387 (D. Del.) | Mar. 25, 2022 | Hon. Maryellen Noreika | Parsabiv® (etelcalcetide injection) | 9,820,938 10,344,765 11,162,500 |
| Fresenius Kabi USA, LLC v. Zydus Pharms. (USA) Inc., 22-1702 (D.N.J.) | Mar. 25, 2022 | Hon. Michael A. Shipp | Levothyroxine sodium powder for injection | 9,006,289 9,168,238 9,168,239 |
| La Jolla Pharm. Co. v. Gland Pharma Ltd., 22-1754 (D.N.J.) | Mar. 29, 2022 | Hon. Julien Xavier Neals | Giapreza® (angiotensin II acetate injection) | 11,219,662 9,220,745 10,028,995 10,493,124 11,096,983 9,572,856 9,867,863 10,335,451 10,500,247 10,548,943 |
| Eisai Co., Ltd. v. Hetero USA Inc., 22-1795 (D.N.J.) | Mar. 31, 2022 | Hon. Christine P. O’Hearn | Banzel® (rufinamide oral suspension) | 6,740,669 |
| Fresenius Kabi USA, LLC v. Steriscience PTE Ltd., 22-1810 (D.N.J.) | Mar. 31, 2022 | Hon. Michael A. Shipp | Levothyroxine sodium powder for injection | 9,006,289 9,168,238 9,168,239 |
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