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Mirum Pharmaceuticals, Inc. v. Annora Pharma Private Limited - 1:25-cv-01537

Mirum Pharmaceuticals, Inc. v. Annora Pharma Private Limited (Case No. 1:25-cv-01537), filed on Dec 19, 2025 in the District Court, D. Delaware involving patent infringement. This case involves patent infringement claims between the parties. Explore details about the litigants, key filings, and major docket updates.

Case Details

Case Number
1:25-cv-01537
Filing Date
Dec 19, 2025
Cause of Action
Patent Infringement
Status
-
Court
District Court, D. Delaware
Nature of Suit
Patent - Abbreviated New Drug Application(ANDA)

Parties Involved

The following parties are involved in this case, with their respective legal representatives for the case.

NameRepresented By
Mirum Pharmaceuticals, Inc. -
Annora Pharma Private Limited -

Patents Involved

This case involves 8 patents, each of which is central to the dispute. These patents may be subject to claims of infringement, challenges to their validity, or other issues concerning their scope and enforcement.

Application NumberPatent Number
-US10512657B2
-US11497745B2
-US11376251B2
-US11229647B2
-US11229661B2
-US11260053B2
-US12350267B2
-US11918578B2

Docket Entries

The Docket Entries section provides a chronological list of all significant filings and court actions in this case.

DateDocket EntryType

Set alerts for critical docket entry

Dec 19, 2025Summons Issued as to Annora Pharma Private Limited on 12/19/2025; Hetero Labs Limited on 12/19/2025; Hetero USA Inc. on 12/19/2025. (Attachments: # 1 Summons Issued, # 2 Summons Issued)(cdd) (Entered: 12/19/2025)PACER Document
Dec 19, 2025Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Mirum Pharmaceuticals, Inc. for Satiogen Pharmaceuticals, Inc.; and Corporate Parent Takeda Pharmaceuticals U.S.A., Inc. and Other Affiliates Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals International AG, Takeda Pharmaceutical Company Limited and The Master Trust Bank of Japan, Ltd. for Shire Human Genetic Therapies, Inc., filed by Mirum Pharmaceuticals, Inc., Satiogen Pharmaceuticals, Inc., and Shire Human Genetic Therapies, Inc. (cdd) (Entered: 12/19/2025)PACER Document
Dec 19, 2025Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) US 10,512,657 B2; US 11,229,661 B2; US 12,350,267 B2; US 11,229,647 B2 ; US 11,376,251 B2; US 11,497,745 B2 ; US 11,918,578 B2; US 11,260,053 B2. (cdd) (Entered: 12/19/2025)PACER Document
Dec 19, 2025Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) - Date Patentee(s) Received Notice: 11/18/2025. Date of Expiration of Patent(s): US 10,512,657 B2 - 10/26/2032; US 11,229,661 B2 - 10/26/2032; US 12,350,267 B2 - 10/26/2032; US 11,229,647 B2 - 02/12/2040; US 11,376,251 B2 - 10/26/2032; US 11,497,745 B2 - 02/12/2040; US 11,918,578 B2 - 02/12/2040; US 11,260,053 B2 - 05/26/2031 Thirty Month Stay Deadline: 3/29/2029. (cdd) (Entered: 12/19/2025)PACER Document
Dec 19, 2025Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (cdd) (Entered: 12/19/2025)PACER Document
Dec 19, 2025COMPLAINT against Annora Pharma Private Limited, Hetero Labs Limited, Hetero USA Inc. (Filing fee $ 405, receipt number ADEDC-4862707) - filed by Satiogen Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc., Shire Human Genetic Therapies, Inc. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Civil Cover Sheet)(cdd) (Entered: 12/19/2025)PACER Document
Dec 23, 2025WAIVER OF SERVICE returned executed by Satiogen Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc., Shire Human Genetic Therapies, Inc.: For Hetero USA Inc. waiver sent on 12/22/2025, answer due 2/20/2026. (Keller, Karen) (Entered: 12/23/2025)PACER Document
Dec 23, 2025WAIVER OF SERVICE returned executed by Satiogen Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc., Shire Human Genetic Therapies, Inc.: For Hetero Labs Limited waiver sent on 12/22/2025, answer due 2/20/2026. (Keller, Karen) (Entered: 12/23/2025)PACER Document
Dec 23, 2025WAIVER OF SERVICE returned executed by Satiogen Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc., Shire Human Genetic Therapies, Inc.: For Annora Pharma Private Limited waiver sent on 12/22/2025, answer due 2/20/2026. (Keller, Karen) (Entered: 12/23/2025)PACER Document
Dec 23, 2025Case Assigned to Judge Jennifer L. Hall. Please include the initials of the Judge (JLH) after the case number on all documents filed. Associated Cases: 1:25-cv-01537-UNA, 1:25-cv-01538-UNA, 1:25-cv-01539-UNA, 1:25-cv-01541-UNA (alb)PACER Document
Dec 19, 2025COMPLAINT against Annora Pharma Private Limited, Hetero Labs Limited, Hetero USA Inc. (Filing fee $ 405, receipt number ADEDC-4862707) - filed by Satiogen Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc., Shire Human Genetic Therapies, Inc. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Civil Cover Sheet)(cdd) (Entered: 12/19/2025)Attachment
Dec 19, 2025COMPLAINT against Annora Pharma Private Limited, Hetero Labs Limited, Hetero USA Inc. (Filing fee $ 405, receipt number ADEDC-4862707) - filed by Satiogen Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc., Shire Human Genetic Therapies, Inc. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Civil Cover Sheet)(cdd) (Entered: 12/19/2025)Attachment
Dec 19, 2025COMPLAINT against Annora Pharma Private Limited, Hetero Labs Limited, Hetero USA Inc. (Filing fee $ 405, receipt number ADEDC-4862707) - filed by Satiogen Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc., Shire Human Genetic Therapies, Inc. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Civil Cover Sheet)(cdd) (Entered: 12/19/2025)Attachment
Dec 19, 2025COMPLAINT against Annora Pharma Private Limited, Hetero Labs Limited, Hetero USA Inc. (Filing fee $ 405, receipt number ADEDC-4862707) - filed by Satiogen Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc., Shire Human Genetic Therapies, Inc. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Civil Cover Sheet)(cdd) (Entered: 12/19/2025)Attachment
Dec 19, 2025COMPLAINT against Annora Pharma Private Limited, Hetero Labs Limited, Hetero USA Inc. (Filing fee $ 405, receipt number ADEDC-4862707) - filed by Satiogen Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc., Shire Human Genetic Therapies, Inc. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Civil Cover Sheet)(cdd) (Entered: 12/19/2025)Attachment
Dec 19, 2025COMPLAINT against Annora Pharma Private Limited, Hetero Labs Limited, Hetero USA Inc. (Filing fee $ 405, receipt number ADEDC-4862707) - filed by Satiogen Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc., Shire Human Genetic Therapies, Inc. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Civil Cover Sheet)(cdd) (Entered: 12/19/2025)Attachment
Dec 19, 2025COMPLAINT against Annora Pharma Private Limited, Hetero Labs Limited, Hetero USA Inc. (Filing fee $ 405, receipt number ADEDC-4862707) - filed by Satiogen Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc., Shire Human Genetic Therapies, Inc. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Civil Cover Sheet)(cdd) (Entered: 12/19/2025)Attachment
Dec 19, 2025COMPLAINT against Annora Pharma Private Limited, Hetero Labs Limited, Hetero USA Inc. (Filing fee $ 405, receipt number ADEDC-4862707) - filed by Satiogen Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc., Shire Human Genetic Therapies, Inc. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Civil Cover Sheet)(cdd) (Entered: 12/19/2025)Attachment
Dec 19, 2025COMPLAINT against Annora Pharma Private Limited, Hetero Labs Limited, Hetero USA Inc. (Filing fee $ 405, receipt number ADEDC-4862707) - filed by Satiogen Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc., Shire Human Genetic Therapies, Inc. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Civil Cover Sheet)(cdd) (Entered: 12/19/2025)Attachment