Patent 12161628
Litigation summary
Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.
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No PTAB proceedings on file. This patent has not been challenged through Inter Partes Review, Post-Grant Review, or Covered Business Method review at the USPTO. The absence is itself a signal — well-asserted patents eventually attract IPRs.
Cases on file (5)
Group view →Specific litigation cases in our database that name US patent 12161628. The free-form analysis below may also discuss cases beyond this list.
- Astellas US LLC et al. v. Dr Reddys Laboratories Ltdfiled Apr 17, 20263:26-cv-04101New Jersey District CourtOpen
Defendants: Dr Reddys Laboratories Ltd
Other patents asserted: 12447128, 12502357, 11839689
The accused products are generic versions of Xtandi 40 mg and 80 mg tablets.
- Astellas Pharma Inc. et al. v. Hikma Pharmaceuticals USA Inc.filed Jan 16, 20253:25-cv-00578U.S. District Court for the District of New JerseyDismissed
Defendants: Hikma Pharmaceuticals USA Inc.
- Astellas Pharma Inc. et al. v. Haimen Pharma Inc. et al.filed Jan 3, 20253:24-cv-09403U.S. District Court for the District of New JerseyOngoing
Defendants: Haimen Pharma Inc. and SinoTherapeutics Inc.
- Astellas Pharma Inc. et al. v. Zydus Pharmaceuticals (USA) Inc. et al.filed Oct 11, 20243:24-cv-09748U.S. District Court for the District of New JerseyConsolidated
Defendants: Zydus Pharmaceuticals (USA) Inc. and Zydus Lifesciences Ltd.
- 3:25-cv-00035U.S. District Court for the District of New JerseyUnknown
Defendants: Ascent Pharmaceuticals, Inc.
Litigation summary
Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.
Multiple Lawsuits Filed Against Generic Drug Makers Over Prostate Cancer Treatment Patent
As of May 7, 2026, U.S. Patent No. 12,161,628, which covers a combination therapy for prostate cancer, is at the center of several lawsuits filed by owner Astellas Pharma Inc. and other related entities. The lawsuits, all filed in the U.S. District Court for the District of New Jersey, target pharmaceutical companies seeking to market generic versions of Astellas's drug, Xtandi® (enzalutamide). The core of the patent's Claim 1 is a "method of treating prostate cancer in a patient to whom rifampin is administered, comprising co-administering to the patient a daily dose of 240 mg enzalutamide."
The litigations are a response to Abbreviated New Drug Applications (ANDAs) filed with the U.S. Food and Drug Administration (FDA) by the generic manufacturers, a standard procedure for seeking approval of generic drugs. The plaintiffs allege that by filing these ANDAs, the defendants are infringing on the '628 patent.
Known litigation involving U.S. Patent 12,161,628 includes the following cases:
1. Astellas Pharma Inc. et al v. Hikma Pharmaceuticals USA Inc.
- Jurisdiction: U.S. District Court for the District of New Jersey
- Case Number: 3:25-cv-00578
- Filing Date: January 16, 2025
- Plaintiffs: Astellas Pharma Inc., Astellas US LLC, Astellas Pharma US, Inc., Medivation LLC, Medivation Prostate Therapeutics LLC
- Defendant: Hikma Pharmaceuticals USA Inc.
- Outcome/Status: The claims and counterclaims in this case were dismissed with prejudice, with each party bearing its own costs. This confirms the information from the previously generated summary.
2. Astellas Pharma Inc. et al v. Haimen Pharma Inc. et al
- Jurisdiction: U.S. District Court for the District of New Jersey
- Case Number: 3:24-cv-09403
- Filing Date: The original complaint was filed in 2024, with an amended complaint that included the '628 patent filed on January 3, 2025.
- Plaintiffs: Astellas Pharma Inc., Astellas US LLC, Astellas Pharma US, Inc., Medivation LLC, Medivation Prostate Therapeutics LLC, The Regents of the University of California
- Defendants: Haimen Pharma Inc., SinoTherapeutics Inc.
- Outcome/Status: This case has been consolidated with case 3:24-cv-09748 for all purposes. All future filings are to be made in the '9403 case. The case appears to be ongoing.
3. Astellas Pharma Inc. et al v. Zydus Pharmaceuticals (USA) Inc. et al
- Jurisdiction: U.S. District Court for the District of New Jersey
- Case Number: 3:24-cv-09748
- Filing Date: October 11, 2024. An amended complaint including the '628 patent was filed on January 3, 2025.
- Plaintiffs: Astellas Pharma Inc., Astellas US LLC, Astellas Pharma US, Inc., Medivation LLC, Medivation Prostate Therapeutics LLC
- Defendants: Zydus Pharmaceuticals (USA) Inc., Zydus Lifesciences Ltd.
- Outcome/Status: This case has been consolidated with case 3:24-cv-09403 and appears to be ongoing.
4. Astellas Pharma Inc. et al v. Ascent Pharmaceuticals, Inc. et al
- Jurisdiction: U.S. District Court for the District of New Jersey
- Case Number: 3:25-cv-00035
- Filing Date: January 2025
- Outcome/Status: Mentioned in court filings for the Hikma case, but further details on the specific defendants and current status are not available in the provided search results.
In addition to the cases listed above, the patent's Google Patents page indicates two other lawsuits in the same jurisdiction, 3:25-cv-15434 and 3:25-cv-13779, though specific details about these cases were not found in the immediate search results. The pattern of litigation suggests an active enforcement strategy by Astellas to protect its market for Xtandi®.
Generated 5/7/2026, 2:06:45 PM