Laurus Drug Patent Portfolio
Laurus's Family Patents
Recent FDA approvals and tentative approvals for Laurus
This section lists recent FDA approvals and tentative approvals for Lupin, covering innovator and generic drugs with key regulatory details and timelines.
Innovator drugs
Includes innovator drug submissions that appear in FDA approval and tentative approval disclosures.
| Drug Name | Submission class (FDA) | Submission Category | Submission Date |
|---|---|---|---|
| Dolutegravir |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | Type 5 - New Formulation or New Manufacturer | 28 Apr, 2023 |
| Dolutegravir; Lamivudine; Tenofovir Disoproxil Fumarate |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | Type 4 - New Combination | 01 Feb, 2019 |
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 |
|---|---|---|---|
| Sitagliptin |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 12 Nov, 2025 |
| Canagliflozin |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 29 Sep, 2025 |
| Tenofovir Alafenamide Fumarate |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 22 Aug, 2025 |
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