Amneal Pharmaceuticals, Inc. et al. vs. Nivagen Pharmaceuticals, Inc.

Explore the PTAB proceeding IPR2025-00731 filed by Amneal Pharmaceuticals, Inc. et al. on 2025-04-11. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Proceeding Overview

Proceeding Number

IPR2025-00731

Filing Date

2025-04-11

Accorded Filing Date

2025-04-11

Institution Decision Date

2025-09-03

Last Modified Date

2025-10-04

Proceeding Type

IPR

Termination Date

2025-09-03

Trial Status

Discretionary Denial

Parties & Counsel

Petitioner

Amneal Pharmaceuticals, Inc. et al.

Represented By

Briggs, Heathet al

Patent Owner / Respondent

Nivagen Pharmaceuticals, Inc.

Represented By

Upadhye, Shashanket al

Tribunal & Venue

Tribunal

Patent Trial and Appeal Board (USPTO)

Technology Center

TC 1600 - Biotechnology & Organic Chemistry

Patent Information

1 Patent Involved

Respondent Application Number 18460941

Respondent Patent Number 11925661

External Links

Espacenet

Google Patents

Respondent Inventor Brijeshkumar B. Pandya et al

Respondent Tech Center TC 1600 - Biotechnology & Organic Chemistry

Address and Attorney/Agent Information

6 Registered Practitioners

Power of Attorney & Correspondence

Firm / Entity Name Umberg Zipser LLP

Customer Number 149344

Address 1920 Main Street Suite 750, Irvine, CA, 92614, UNITED STATES

Attorney / Agent Information

Reg #	Name	Phone
46697	Martin Fessenmaier	949-679-0052
56122	Mei Tsang	949-679-0052
61570	Ryan Dean	949-679-0052
70109	Priti Phukan	949-679-0052
81519	Darian Mcmillan	858-922-4780
83775	Nasser Khateeb	949-679-0052

Proceeding Documents

Director Discretionary Decision: Deny RESPONSE

2025-09-03 FILING PARTY: BOARD

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20250825 Patent Owner Nivagen Updated Mandatory Notice 661 pat IPR 00731 NOTICE

2025-08-25 FILING PARTY: PATENT OWNER

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20250825 Patent Owner Nivagen Updated Power of Atty '661 IPR00731 (executed) NOTICE

2025-08-25 FILING PARTY: PATENT OWNER

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Petitioner's Opposition to Patent Owner's Brief in Support of Discretionary Denial RESPONSE

2025-08-20 FILING PARTY: PETITIONER

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1040

Ex1040-SchedulingOrder-1_22-cv-01190-GBW_280 Exhibit

2025-08-20 FILING PARTY: PETITIONER

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Amneal Pharmaceuticals, Inc. et al. vs. Nivagen Pharmaceuticals, Inc.

Proceeding Overview

Parties & Counsel

Petitioner

Amneal Pharmaceuticals, Inc. et al.

Represented By

Patent Owner / Respondent

Nivagen Pharmaceuticals, Inc.

Represented By

Tribunal & Venue

Patent Information

Address and Attorney/Agent Information

Power of Attorney & Correspondence

Attorney / Agent Information

Proceeding Documents

Director Discretionary Decision: Deny RESPONSE

20250825 Patent Owner Nivagen Updated Mandatory Notice 661 pat IPR 00731 NOTICE

20250825 Patent Owner Nivagen Updated Power of Atty '661 IPR00731 (executed) NOTICE

Petitioner's Opposition to Patent Owner's Brief in Support of Discretionary Denial RESPONSE

Ex1040-SchedulingOrder-1_22-cv-01190-GBW_280 Exhibit

Order: ORDER Granting Patent Owner’s Motion for Admission Pro Hac Vice of Yixin H. Tang 37 C.F.R. § 42.10 ORDER

Ex1038-JudgeWilliams-Stats Exhibit

Ex1039-SchedulingOrder-1_22-cv-00266-JDW_133 Exhibit

Ex1042-SchedulingOrder-1_23-cv-01095-GBW_36 Exhibit

Ex1041-SchedulingOrder-1_25-cv-00338-GBW_16 Exhibit

ORDER Conditionally Granting Patent Owner’s Motion for Admission Pro Hac Vice of Christopher M. Bruno 37 C.F.R. § 42.10 ORDER

Ex2032-RabinowDecl-POPR Exhibit

Ex2029-VanDerLinden Exhibit

Ex2030-NorwoodDecl-POPR Exhibit

Ex2027-ECETOC-TR-110-Guidance Exhibit

20250819 Nivagen's Pat Own Prelim Resp '661 patent IPR2025-00731 POPR

20250819 Patent Owner Nivagen Motion for C. Bruno PHV '661 pat IPR 00731 MOTION

Ex2031-NorwoodCV Exhibit

Ex2028-WHO-chapter5-dose-response Exhibit

Ex2023-DI102-Reply-MTD Exhibit

Ex2011-Graves-2011 Exhibit

Ex2009-Rosenthal-2004 Exhibit

Ex2018-DI42-Reply-PI Exhibit

Ex2021-DI95-MTD Exhibit

Ex2002-Sakowski-Decl-661 Exhibit

Ex2010-Franzetti-2009 Exhibit

Ex2007-RabinowCV Exhibit

Ex2006-Rabinow-Decl-661 Exhibit

Ex2001-US10632150-Thomas Exhibit

Ex2013-US11141430-Koneru Exhibit

Ex2008-Rangel-Frausto-2010 Exhibit

Ex2004-Examiner-ReportAL-AWADI Exhibit

Ex2026-DI29-AmijiDec Exhibit

Ex2015-Nivagen-v-Amneal-DDel-Docket Exhibit

20250717-Patent Owner Brief Support Request of Discr Denial IPR2025-00731 Patent No 11925661 RESPONSE

Ex2022-DI101-OppBr-MTD Exhibit

Ex2012-Lutwick2019 Exhibit

Ex2020-DI93-AnsCCs Exhibit

Ex2017-DI36-OppoBr-PI Exhibit

Ex2005-Compare-Thomas-Ex1007 Exhibit

Ex2014-JtComm-2013 Exhibit

Ex2003-CA-24-846-DI-61-Opinion Exhibit

Ex2016-DI22-OpenBr Exhibit

Ex2024-Email-Sotera Exhibit

Motion Pro Hac Vice - Yixin Tang MOTION

Notice: Mandatory Notice NOTICE

Notice: Power of Attorney NOTICE

Notice: Notice filing date accorded NOTICE

FDA, NDA approval letter to CMP Development LLC, Sept. 2019 Exhibit

U.S. Patent Application Publication No. 2022/0110969 Exhibit

U.S. Patent No. 5,783,269 Exhibit

Brunelli Exhibit

Declaration of Mina Ching from the Internet Archive (archive.org) Exhibit

U.S. Patent No. 11,925,661 Exhibit

Statistics for Judge Williams and D. Del. Exhibit

Wadsworth Exhibit

Dailymed CMP FDA Drug Label September 23, 2020, Internet Archive Exhibit

FDA Drug Label “POTASSIUM PHOSPHATES injection, for intravenous use,” 2019 Exhibit

Amended Complaint, Nivagen Pharma. Inc. v. Amneal Pharma. Inc. Exhibit

Terlevich Exhibit

U.S. Patent No. 5,896,989 Exhibit

Ex Parte Shirley Exhibit

Nema Exhibit

Declaration of Dr. Mansoor Amiji Exhibit

Rowe Exhibit