Sunshine Lake Drug Patent Portfolio

Sunshine Lake's Family Patents


Family Patents



Recent FDA approvals and tentative approvals for Sunshine Lake

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
Mirabegron ORIG-1
ⓘ
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 10 Dec, 2025
Tenofovir Alafenamide ORIG-1
ⓘ
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 08 Jul, 2021
Apixaban ORIG-1
ⓘ
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 10 Sep, 2019


Clinical Trials

Recent Clinical Trials by Sunshine Lake:

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
HEC-921 Injection as Monotherapy and in Combination With Antineoplastic Therapies in Patients With Advanced Malignant Solid Tumors Sunshine Lake Pharma Co., Ltd. NA RECRUITING
(Sep 1, 2026)
PHASE1
Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer Sunshine Lake Pharma Co., Ltd. NA RECRUITING
(Aug 1, 2026)
PHASE3
A Phase I Clinical Trial to Evaluate HECN30227 Injection in Healthy Subjects and Subjects With Chronic Hepatitis B Sunshine Lake Pharma Co., Ltd. NA RECRUITING
(Aug 1, 2026)
PHASE1
Ningetinib (CT053PTSA) Plus Gefitinib in Stage IIIB or IV NSCLC Patients With EGFR Mutation and T790M Negative Sunshine Lake Pharma Co., Ltd. NA COMPLETED
(May 1, 2026)
PHASE1, PHASE2
A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML Sunshine Lake Pharma Co., Ltd. NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Phase ll Study of HEC585 in Patients With IPF Sunshine Lake Pharma Co., Ltd. NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML Sunshine Lake Pharma Co., Ltd. NA RECRUITING
(Apr 1, 2026)
PHASE3
Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF Sunshine Lake Pharma Co., Ltd. NA RECRUITING
(Apr 1, 2026)
PHASE3


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Drugs Generating Over $1 Billion in Annual Revenue
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NCE-1 Patent Expiry in the Next 1 Year
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