Lupin Ltd Drug Patent Portfolio

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

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US9233112 Pharmaceutical compositions of cefixime 14 Dec, 2028
Active


Lupin Ltd's Family Patents

Lupin Ltd drugs have patent protection in a total of 3 countries. It's US patent count contributes only to 50.0% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree.

Family Patents



Recent FDA approvals and tentative approvals for Lupin Ltd

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;lamivudine;tenofovir Alafenamide ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
Type 4 - New Combination 18 Jul, 2023
Dolutegravir; Emtricitabine; Tenofovir Alafenamide ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
Type 4 - New Combination 19 Jan, 2023
Dolutegravir, Lamivudine And Tenofovir Disoproxil Fumarate ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
Type 4 - New Combination 25 Jun, 2021

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
Oxcarbazepine Extended Release Tablets ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 06 Jun, 2025
Ivacaftor ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 08 Jan, 2025
Abacavir; Dolutegravir; Lamivudine ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 03 Dec, 2024

Lupin Ltd Drug List

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


1. Suprax

Suprax is protected by 1 patent, which is still active. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US9233112 Pharmaceutical compositions of cefixime 14 Dec, 2028
(2 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 Suprax's drug page


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Lupin Ltd News

Upcoming expirations of GLP-1 drug patents attract generic manufacturers - C&EN

09 Dec, 2025

NCLAT rules that CCI is unable to investigate anti-competitive behavior related to patented medications - Bar and Bench

31 Oct, 2025

Boost for Indian pharmaceutical companies as US FDA relaxes regulations on biosimilar approvals.

31 Oct, 2025

ANDA Litigation Settlements for Q3 2025 | Robins Kaplan LLP - JDSupra

30 Oct, 2025

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