Shandong Drug Patent Portfolio

Shandong owns 1 orange book drug protected by 5 US patents Given below is the list of Shandong's drug patents along with their expiration dates.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US10098882 Risperidone sustained release microsphere composition 10 Apr, 2032
Active
US10406161 Risperidone sustained release microsphere composition 10 Apr, 2032
Active
US11110094 Risperidone sustained release microsphere composition 10 Apr, 2032
Active
US9446135 Risperidone sustained release microsphere composition 10 Apr, 2032
Active
US9532991 Risperidone sustained release microsphere composition 10 Apr, 2032
Active


Given below is the list of recent legal activities going on the following drug patents of Shandong.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 06 Mar, 2025 US11110094
Payment of Maintenance Fee, 8th Year, Large Entity 03 Jul, 2024 US9532991
Payment of Maintenance Fee, 8th Year, Large Entity 19 Mar, 2024 US9446135
Payment of Maintenance Fee, 4th Year, Large Entity 10 Mar, 2023 US10406161
Payment of Maintenance Fee, 4th Year, Large Entity 28 Mar, 2022 US10098882
Patent Issue Date Used in PTA Calculation 07 Sep, 2021 US11110094
Recordation of Patent Grant Mailed 07 Sep, 2021 US11110094
Email Notification 19 Aug, 2021 US11110094
Issue Notification Mailed 18 Aug, 2021 US11110094
Application Is Considered Ready for Issue 05 Aug, 2021 US11110094
Dispatch to FDC 05 Aug, 2021 US11110094
Issue Fee Payment Received 04 Aug, 2021 US11110094
Issue Fee Payment Verified 04 Aug, 2021 US11110094
Electronic Review 05 May, 2021 US11110094
Email Notification 05 May, 2021 US11110094


Shandong Drug Patents' Oppositions Filed in EPO

Shandong drug patents have faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 20, 2017, by Lecomte & Partners. This opposition was filed on patent number EP12777430A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP19176691A Jul, 2021 Alkermes Pharma Ireland Limited Opposition rejected
EP16179390A Apr, 2020 Alkermes Pharma Ireland Limited Opposition rejected
EP16179390A Apr, 2020 Aera A/S Opposition rejected
EP12777430A Jun, 2017 Lecomte & Partners Opposition rejected


Shandong's Family Patents

Shandong drugs have patent protection in a total of 14 countries. It's US patent count contributes only to 17.1% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree.

Family Patents



Recent FDA approvals and tentative approvals for Shandong

This section lists recent FDA approvals and tentative approvals for Lupin, covering innovator and generic drugs with key regulatory details and timelines.


Generic drugs

Includes generic drug submissions with tentative FDA approvals, not yet marketable due to patent or exclusivity restrictions.

Drug Name Submission class (FDA) Submission Category Submission Date
Brivaracetam ORIG-1
ⓘ
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 26 Feb, 2026


Clinical Trials

Recent Clinical Trials by Shandong:

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Adaptive Boost Radiotherapy to Primary Lesions and Positive Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer Shandong Cancer Hospital and Institute NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + Surgery/SBRT for BCLC-C HCC With PVTT and/or Oligometastases Shandong Cancer Hospital and Institute NA RECRUITING
(Sep 1, 2026)
PHASE2
A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis Shandong Suncadia Medicine Co., Ltd. NA COMPLETED
(Sep 1, 2026)
PHASE1
Tislelizumab Combined With Anlotinib and Nab-paclitaxel in III Resectable Non-small Cell Lung Cancer : A Prospective, Single-Arm, Phase II Study Qilu Hospital of Shandong University NA RECRUITING
(Aug 1, 2026)
PHASE2
Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in pMMR/MSS Locally Advanced Rectal Cancer Shandong Cancer Hospital and Institute NA RECRUITING
(Aug 1, 2026)
PHASE3
A Phase II/III Study of F520 Combined With Paclitaxel Plus Carboplatin in the Treatment of Cancer of Unknown Primary (CUP) Shandong New Time Pharmaceutical Co., LTD NA RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
A Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese or Overweight Subjects Shandong Suncadia Medicine Co., Ltd. NA COMPLETED
(Jun 1, 2026)
PHASE1
A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in Healthy Participants Shandong Suncadia Medicine Co., Ltd. NA RECRUITING
(Jun 1, 2026)
PHASE1
Fluzoparib + Bevacizumab vs Olaparib + Bevacizumab for Maintenance Therapy in HRD-Positive Advanced Ovarian Cancer Shandong University NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
SBRT Followed by Ipilimumab N01, Sintilimab, Nab-Paclitaxel and Gemcitabine for Locally Advanced Pancreatic Cancer Shandong Cancer Hospital and Institute NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Clinical Study of HRS-2129 for Postoperative Analgesia in Orthopaedics Shandong Suncadia Medicine Co., Ltd. NA COMPLETED
(May 1, 2026)
PHASE1, PHASE2
Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer Shandong Cancer Hospital and Institute NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer Shandong Suncadia Medicine Co., Ltd. NA RECRUITING
(May 1, 2026)
PHASE3
Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy Qilu Hospital of Shandong University NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Progesterone-modified Natural Cycle for FET Shandong University of Traditional Chinese Medicine NA RECRUITING
(Apr 1, 2026)
PHASE3
Study on Drug Interaction of Metformin Tablets and HRS-7535 Tablets in Healthy Human Shandong Suncadia Medicine Co., Ltd. NA COMPLETED
(Apr 1, 2026)
PHASE1
Clinical Study of Low-dose Interval Radiotherapy Combined With Tirelizumab and SOX Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Shandong Provincial Hospital NA RECRUITING
(Apr 1, 2026)
PHASE2
Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND) Shandong Cancer Hospital and Institute NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain Shandong Suncadia Medicine Co., Ltd. NA RECRUITING
(Apr 1, 2026)
PHASE1
High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia Shandong University NA RECRUITING
(Apr 1, 2026)
PHASE3
Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases Shandong Cancer Hospital and Institute NA RECRUITING
(Mar 1, 2026)
PHASE2
Carilizumab and Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer Shandong Tumor Hospital NA RECRUITING
(Mar 1, 2026)
PHASE2
A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer Shandong Suncadia Medicine Co., Ltd. NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2


Shandong Drug List

Given below is the complete list of Shandong's drugs and the patents protecting them.


1. Rykindo

Rykindo is protected by 5 patents, out of which none have expired yet. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US10098882 Risperidone sustained release microsphere composition 10 Apr, 2032
(5 years from now)
Active
US10406161 Risperidone sustained release microsphere composition 10 Apr, 2032
(5 years from now)
Active
US11110094 Risperidone sustained release microsphere composition 10 Apr, 2032
(5 years from now)
Active
US9446135 Risperidone sustained release microsphere composition 10 Apr, 2032
(5 years from now)
Active
US9532991 Risperidone sustained release microsphere composition 10 Apr, 2032
(5 years from now)
Active

Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Rykindo's drug page


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