Macleods Drug Patent Portfolio
Macleods's Family Patents
Recent FDA approvals and tentative approvals for Macleods
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 Sodium |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | Type 5 - New Formulation or New Manufacturer | 16 Mar, 2021 |
| Dolutegravir; Lamivudine; Tenofovir Disoproxil Fumarate |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | Type 4 - New Combination | 25 Mar, 2019 |
| Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | Type 5 - New Formulation or New Manufacturer | 14 Aug, 2014 |
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 |
|---|---|---|---|
| Vortioxetine Hydrobromide |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 10 Nov, 2025 |
| Dapagliflozin |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 15 Oct, 2025 |
| Canagliflozin And Metformin Hydrochloride |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 01 Oct, 2025 |
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