Exela Pharma Sciences, LLC v. Nivagen Pharmaceuticals, Inc. et al.
Infringement action filed 6 Feb 2023 in the United States District Court for the District of Delaware and closed 30 Jun 2023, with 2 patents asserted. Recorded basis of termination: case dismissed.
Case record
- Patents involved
- US10583155B1US11510941B1
- Case no.
- 1:23-cv-00137
- Verdict cause
- Infringement action
- Court
- D. Del.
- Court level
- District Court
- Case region
- Delaware
- Chief judge
- Maryellen Noreika
- Trial level
- First instance
- Filed – Closed
- 6 Feb 2023 – 30 Jun 2023
- Duration
- 144 days
- Basis of termination
- Case Dismissed
- Products & marks
- Stable, highly pure L-cysteine compositions for injection and methods of use
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Stable, highly pure L-cysteine compositions for injection and methods of use
The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace O2 that is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.
- Legal status
- Active
- Granted
- 10 Mar 2020
- Est. expiry
- 15 Jan 2039
- Validity challenges
- 1 on recordPGR2020-00068 · Other · filed by Eton Pharmaceuticals Inc.
- Licences recorded
- None recorded
- Inventors
- MALONEY, JOHN · KOGANTI, ARUNA · KONERU, PHANESH
- Classification
- A61K33/06A61K33/241A61K31/401A23L33/175A23L33/16A61K33/28A61K33/36A61K31/405A61K31/095A61K9/00A61K33/00A61K47/02A61K31/191A61K31/198A61K31/4172A61J1/14
- Prosecution counsel
- ALSTON & BIRD LLP
- Examiner
- PACKARD, BENJAMIN J
Stable, highly pure L-cysteine compositions for injection and methods of use
The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace O2 that is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.
- Legal status
- Active
- Granted
- 29 Nov 2022
- Est. expiry
- 2 Mar 2039
- Validity challenges
- None recorded
- Licences recorded
- None recorded
- Inventors
- MALONEY, JOHN · KOGANTI, ARUNA · KONERU, PHANESH
- Classification
- A61K31/4172A61K33/06A61K31/191A61K47/02A61K33/36A61K33/241A61K33/28A61K33/00A61K31/405A61K31/401A61K9/00A23L33/175A23L33/16A61K31/198A61K31/095A61J1/14
- Prosecution counsel
- ALSTON & BIRD LLP
- Examiner
- PACKARD, BENJAMIN J
Parties of record
Exela Pharma Sciences, LLC
- Core tech
- A61K33/06A61K33/241A61K31/401A23L33/175
- Counsel
- Christina D. Brown-Marshall · Corrin N. Drakulich · Deanna J. Reichel · Douglas Edward McCann · Elizabeth M. Flanagan · Gregory Robert Booker · Karrie Wheatley
- Firm
- Cooley LLP (Library), Fish & Richardson PC
Nivagen Pharmaceuticals, Inc.
- Core tech
- Not recorded
- Counsel
- Brent A. Batzer · Richard Charles Weinblatt · Shashank D. Upadhye · Stamatios Stamoulis · Yixin Tang
- Firm
- Stamoulis & Weinblatt LLC
- Also named
- Hikma Pharmaceuticals USA, Inc.
Counsel of record
Basis of termination
From the record · verbatim“[SEALED] STIPULATION ofDismissal byExela Pharma Sciences, LLC. (Booker, Gregory) (Entered: 06/30/2023).”
Case 1:23-cv-00137 · D. Del. · closed 30 June 2023
Related cases
Three questions this record usually leads to. Each one runs against the full litigation and patent corpus, and cites what it finds.
Frequently asked questions
What is case 1:23-cv-00137?
1:23-cv-00137 is a patent infringement action brought by Exela Pharma Sciences, LLC against Nivagen Pharmaceuticals, Inc., filed on 6 Feb 2023 in the United States District Court for the District of Delaware. The case closed on 30 June 2023.
Which patents were asserted in 1:23-cv-00137?
US10583155B1 (“Stable, highly pure L-cysteine compositions for injection and methods of use”), assigned to EXELA PHARMA SCIENCES, LLC, currently active; US11510941B1 (“Stable, highly pure L-cysteine compositions for injection and methods of use”), assigned to EXELA PHARMA SCIENCES, LLC, currently active. The record also lists Stable, highly pure L-cysteine compositions for injection and methods of use.
How was case 1:23-cv-00137 terminated?
The recorded basis of termination is case dismissed. The termination text reads: “[SEALED] STIPULATION ofDismissal byExela Pharma Sciences, LLC. (Booker, Gregory) (Entered: 06/30/2023).”
How long did case 1:23-cv-00137 take?
144 calendar days, from filing on 6 Feb 2023 to closure on 30 June 2023.
Who were the attorneys and the judge in 1:23-cv-00137?
Chief Judge Maryellen Noreika presided. Christina D. Brown-Marshall, Corrin N. Drakulich, Deanna J. Reichel, Douglas Edward McCann, Elizabeth M. Flanagan, Gregory Robert Booker and Karrie Wheatley are recorded as counsel for plaintiff Exela Pharma Sciences. Brent A. Batzer, Richard Charles Weinblatt, Shashank D. Upadhye, Stamatios Stamoulis and Yixin Tang appear for defendant Nivagen Pharmaceuticals.
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