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EXELA PHARMA SCIENCES, LLC - COMPLAINT","","Civil complaint filed in the U.S. District Court for the District of Delaware by Nexus Pharmaceuticals, Inc. against Exela Pharma Sciences, LLC alleging patent infringement and seeking declaratory judgment. The claims focus on Exela’s manufacture, use, offer for sale, and sale of an ephedrine sulfate 25 mg/5 mL solution in a 5 mL prefilled syringe sold under the brand name AKOVAZ, alleged to infringe the ’369 patent. The pleading also describes jurisdiction, venue, the parties’ roles, and background regarding related FDA approvals and the development of ready-to-use ephedrine formulations.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":41,"@type":70,"position":76},"https://docshare.wps.com/template/letters/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/nexus-pharmaceuticals-inc-v-exela-pharma-sciences-llc-complaint/278129/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/nexus-pharmaceuticals-inc-v-exela-pharma-sciences-llc-complaint/278129.png","ImageObject",442,249,{"name":88,"@type":89},"Riley","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-27","2026-09-15",true,{"@type":98,"interactionType":99,"userInteractionCount":20},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"Who are the parties in the complaint and what roles do they have?","Question",{"text":108,"@type":109},"Nexus Pharmaceuticals, Inc. is the plaintiff. 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No.    \nJURY TRIAL DEMANDED  \nCOMPLAINT  \nPlaintiff Nexus Pharmaceuticals, Inc. (“Nexus” or “Plaintiff”) by its undersigned attorneys, for its Complaint against defendant Exela Pharma Sciences, LLC (“Exela” or “Defendant”), alleges as follows:  \nNATURE OF THE ACTION  \n1. This is a civil action for patent infringement arising under the patent laws of the United States, Title 35 of the United States Code, and for a declaratory judgment of patent infringement under 28 U.S.C. §§ 2201 and 2202 and the patent laws of the United States, Title 35, United States Code, that arises out of Defendant’s manufacturing, using, offering for sale, and selling an ephedrine sulfate 25 mg/5 mL (5 mg/mL) solution in a 5 mL prefilled syringe under the brand name AKOVAZ that infringes claims of Nexus’s U.S. Patent No. 11,426,369 (“the ’369 patent” or “the patent in suit”) .  \nPARTIES  \n2. Nexus is a corporation organized and existing under the laws of the State of Illinois, having its principal place of business at 400 Knightsbridge Parkway, Lincolnshire, Illinois.  \nRLF1 27888539v.1  \nCase 1:22-cv-01233-GBW Document 1 Filed 09/21/22 Page 2 of 7 PageID \\#: 2  \n3. Nexus is the holder of New Drug Application No. 213407 for EMERPHED®,(ephedrine sulfate) 50mg/10ml (5 mg/mL) IV solution. EMERPHED® was the first FDAapproved “ready to use” formulation with a 5 mg/mL concentration.  \n4. Nexus applied for and obtained patents related to its inventions for the ready to use 5 mg/mL concentration, including the ’369 patent. Nexus is the owner and assignee of the ’369 patent.  \n5. Exela is a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 1245 Blowing Rock Blvd, Lenoir, NC, 28645.  \n6. Upon information and belief, Exela is a pharmaceutical manufacturer and seller that specializes in “the development and manufacturing of generic and proprietary sterile injectable products with high barriers to market entry, via an Abbreviated New Drug Approval or 505(b)(2) regulatory pathway.”1  \n7. Upon information and belief, Exela derives substantial revenue from the manufacture, compounding, and/or sale of generic pharmaceutical products throughout the United States, including in Delaware.  \nJURISDICTION AND VENUE  \n8. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.  \n9. Personal jurisdiction and venue are proper in this Court under 28 U.S.C. §§ 1391 and 1400(b), at least because Exela is incorporated in Delaware. Exela is a company organized and existing under the laws of the State of Delaware, is registered to do business in this State, and has appointed a registered agent to accept service.  \n1 Corporate Overview, [https://www.exelapharma.com/overview/](https://www.exelapharma.com/overview/) (last visited August 20, 2022) .  \n2  \nRLF1 27888539v.1  \nCase 1:22-cv-01233-GBW Document 1 Filed 09/21/22 Page 3 of 7 PageID \\#: 3  \n10. On information and belief, Exela has manufactured and will manufacture a prefilled syringe product pursuant to its sNDA No. 208289/S-006 and has and will continue to offer for sale and sell its infringing prefilled syringe product in the United States, including in Delaware.  \nBACKGROUND  \n11. EMERPHED® is sold and marketed under New Drug Application No. 213407, which was approved by the FDA in April 2020.  \n12. Ephedrine, the active ingredient in EMERPHED®, is an alpha-and beta-adrenergic agonist and a norepinephrine-releasing agent. EMERPHED® is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.  \n13. The ’369 patent, entitled “Compositions comprising Ephedrine or an ephedrine salt and methods of making and using same” ","cbCaihrbUqkoOfEe","https://ap.wps.com/l/cbCaihrbUqkoOfEe","pdf",177452,7,"English","# Parties\n## Nexus Pharmaceuticals, Inc.\n## Exela Pharma Sciences, LLC\n# Nature of the Action\n## Patent infringement and declaratory judgment\n# Jurisdiction and Venue\n# Background\n## FDA approvals and related patents","[{\"question\":\"Who are the parties in the complaint and what roles do they have?\",\"answer\":\"Nexus Pharmaceuticals, Inc. is the plaintiff. Exela Pharma Sciences, LLC is the defendant and is alleged to manufacture and sell the accused pharmaceutical product.\"},{\"question\":\"What product and activity are alleged to infringe the asserted patent?\",\"answer\":\"The complaint alleges Exela’s manufacture, use, offering for sale, and sale of an ephedrine sulfate 25 mg/5 mL solution in a 5 mL prefilled syringe sold as AKOVAZ infringes Nexus’s ’369 patent claims.\"},{\"question\":\"On what legal bases does the complaint rely for jurisdiction and relief?\",\"answer\":\"The pleading invokes U.S. patent laws and seeks declaratory judgment under 28 U.S.C. §§ 2201 and 2202, along with provisions supporting subject-matter jurisdiction and venue.\"}]","NEXUS PHARMACEUTICALS, INC. v. EXELA PHARMA SCIENCES, LLC - COMPLAINT | PDF",1789507169]