Cipla Usa Drug Patent Portfolio

Cipla Usa owns 1 orange book drug protected by 4 US patents Given below is the list of Cipla Usa's drug patents along with their expiration dates.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US8383596 Antibacterial aminoglycoside analogs 02 Jun, 2031
Active
US8822424 Antibacterial aminoglycoside analogs 21 Nov, 2028
Active
US9266919 Antibacterial aminoglycoside analogs 21 Nov, 2028
Active
US9688711 Antibacterial aminoglycoside analogs 21 Nov, 2028
Active


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

Activity Date Patent Number
Patent litigations
FDA Final Eligibility Letter 30 Jan, 2024 US8822424
FDA Final Eligibility Letter 30 Jan, 2024 US8383596
Payment of Maintenance Fee, 8th Yr, Small Entity 23 Aug, 2023 US9266919
transaction for FDA Determination of Regulatory Review Period 15 May, 2023 US8383596
transaction for FDA Determination of Regulatory Review Period 15 May, 2023 US8822424
transaction for FDA Determination of Regulatory Review Period 18 Apr, 2023 US8383596
transaction for FDA Determination of Regulatory Review Period 18 Apr, 2023 US8822424
Payment of Maintenance Fee, 8th Yr, Small Entity 02 Mar, 2022 US8822424
Payment of Maintenance Fee, 4th Yr, Small Entity 28 Dec, 2020 US9688711
Second letter to regulating agency to determine regulatory review period 24 Sep, 2020 US8822424
Second letter to regulating agency to determine regulatory review period 24 Sep, 2020 US8383596
7.5 yr surcharge - late pmt w/in 6 mo, Small Entity 28 Aug, 2020 US8383596
Payment of Maintenance Fee, 8th Yr, Small Entity 28 Aug, 2020 US8383596
Email Notification 14 May, 2020 US8822424
Change in Power of Attorney (May Include Associate POA) 14 May, 2020 US8383596


Cipla Usa's Family Patents

Cipla Usa drugs have patent protection in a total of 21 countries. It's US patent count contributes only to 32.4% 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 Cipla Usa

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 30 Mar, 2022
Abacavir And Lamivudine ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
Type 3 - New Dosage Form 06 Apr, 2017
Lopinavir And Ritonavir ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
Type 5 - New Formulation or New Manufacturer 21 May, 2015

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
Bictegravir, Emtricitabine And Tenofovir Alafenamide ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 14 Oct, 2025
Emtricitabine And Tenofovir Alafenamide ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 10 Oct, 2025
Nintedanib ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 02 Jul, 2025

Explore deeper patents analysis

Cipla Usa Drug List

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


1. Zemdri

Zemdri is protected by 4 patents, out of which none have expired yet. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US8383596 Antibacterial aminoglycoside analogs 02 Jun, 2031
(5 years from now)
Active
US8822424 Antibacterial aminoglycoside analogs 21 Nov, 2028
(2 years from now)
Active
US9266919 Antibacterial aminoglycoside analogs 21 Nov, 2028
(2 years from now)
Active
US9688711 Antibacterial aminoglycoside analogs 21 Nov, 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 Zemdri's drug page


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