Ani Pharma Drug Patent Portfolio

Ani Pharma owns 5 orange book drugs protected by 16 US patents with Innopran Xl having the least patent protection, holding only 1 patent. And Veregen with maximum patent protection, holding 5 patents. Given below is the list of Ani Pharma's drug patents along with their expiration dates.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US11975047 Methods for storing and warming purified corticotropin compositions 27 Oct, 2043
Active
US12102662 Methods for storing and warming purified corticotropin compositions 27 Oct, 2043
Active
US12233105 Methods for storing and warming purified corticotropin compositions 27 Oct, 2043
Active
US12324787 Contactless optical process for identifying objects 27 Oct, 2043
Active
US12440542 27 Oct, 2043
Active
US7858662 Medicament for the treatment of viral skin and tumour diseases 02 Oct, 2026
Active
US9770406 Medicament for the treatment of viral skin and tumour diseases 12 Jul, 2025 Expired
US10434059 Medicament for the treatment of viral skin and tumour diseases 18 Nov, 2022 Expired
US6500454 Timed, sustained release systems for propranolol 04 Oct, 2021 Expired
US5795911 Composition for treating Condyloma acuminata 31 Oct, 2020 Expired
US5968973 Method for treating hyperplasia 10 Apr, 2017 Expired
US5721263 Pharmaceutical composition for angiotensin II-mediated diseases 24 Feb, 2015 Expired
US5958961 Pharmaceutical composition for angiotensin II-mediated diseases 06 Jun, 2014 Expired
US5534534 Pharmaceutical compositions for oral use and method of preparing them 09 Jan, 2014 Expired
US5534534 Pharmaceutical compositions for oral use and method of preparing them 09 Jul, 2013 Expired
US5196444 1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylate and compositions and methods of pharmaceutical use thereof 04 Dec, 2012 Expired


Given below is the list of recent legal activities going on the following drug patents of Ani Pharma.

Activity Date Patent Number
Patent litigations
Information Disclosure Statement considered 04 Sep, 2025 US12440542
Date Forwarded to Examiner 28 Aug, 2025 US12440542
track 1 ON 28 Aug, 2025 US12440542
Response after Non-Final Action 18 Aug, 2025 US12440542
PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED 18 Aug, 2025 US12440542
Terminal Disclaimer Filed 18 Aug, 2025 US12440542
Electronic Review 16 Jul, 2025 US12440542
Email Notification 16 Jul, 2025 US12440542
Mail Non-Final Rejection 16 Jul, 2025 US12440542
Non-Final Rejection 12 Jul, 2025 US12440542
Information Disclosure Statement considered 12 Jul, 2025 US12440542
Case Docketed to Examiner in GAU 29 Jun, 2025 US12440542
Track 1 Request Granted 23 Jun, 2025 US12440542
Case Docketed to Examiner in GAU 19 Jun, 2025 US12440542
Application Dispatched from OIPE 19 Jun, 2025 US12440542


Ani Pharma's Drug Patent Litigations

Ani Pharma's drugs have been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Sep 08, 2015, against patent number US9770406. The petitioner , challenged the validity of this patent, with Yunik Chang et al as the respondent. Click below to track the latest information on how companies are challenging Ani Pharma's patents.

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9770406 September, 2015 Decision
(07 Feb, 2017)
Yunik Chang et al


Ani Pharma's Family Patents

Ani Pharma drugs have patent protection in a total of 21 countries. It's US patent count contributes only to 15.6% of its total global patent coverage. 14 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 Ani Pharma

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
Memantine Hydrochloride And Donepezil Hydrochloride ORIG-2
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 15 Dec, 2023

Ani Pharma Drug List

Given below is the complete list of Ani Pharma's drugs and the patents protecting them.


1. Atacand

Atacand is protected by 3 patents, out of which all have expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US5534534
(Pediatric)
Pharmaceutical compositions for oral use and method of preparing them 09 Jan, 2014
(12 years ago)
Expired
US5534534 Pharmaceutical compositions for oral use and method of preparing them 09 Jul, 2013
(12 years ago)
Expired
US5196444
(Pediatric)
1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylate and compositions and methods of pharmaceutical use thereof 04 Dec, 2012
(13 years ago)
Expired

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 Atacand's drug page


2. Atacand Hct

Atacand Hct is protected by 5 patents, out of which all have expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US5721263 Pharmaceutical composition for angiotensin II-mediated diseases 24 Feb, 2015
(11 years ago)
Expired
US5958961 Pharmaceutical composition for angiotensin II-mediated diseases 06 Jun, 2014
(11 years ago)
Expired
US5534534
(Pediatric)
Pharmaceutical compositions for oral use and method of preparing them 09 Jan, 2014
(12 years ago)
Expired
US5534534 Pharmaceutical compositions for oral use and method of preparing them 09 Jul, 2013
(12 years ago)
Expired
US5196444
(Pediatric)
1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylate and compositions and methods of pharmaceutical use thereof 04 Dec, 2012
(13 years ago)
Expired

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 Atacand Hct's drug page


3. Innopran Xl

Innopran Xl is protected by 1 patent, which has expired already. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US6500454 Timed, sustained release systems for propranolol 04 Oct, 2021
(4 years ago)
Expired

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 Innopran Xl's drug page


4. Purified Cortrophin Gel

Purified Cortrophin Gel is protected by 5 patents, out of which none have expired yet. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US11975047 Methods for storing and warming purified corticotropin compositions 27 Oct, 2043
(17 years from now)
Active
US12102662 Methods for storing and warming purified corticotropin compositions 27 Oct, 2043
(17 years from now)
Active
US12233105 Methods for storing and warming purified corticotropin compositions 27 Oct, 2043
(17 years from now)
Active
US12324787 Contactless optical process for identifying objects 27 Oct, 2043
(17 years from now)
Active
US12440542 27 Oct, 2043
(17 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 Purified Cortrophin Gel's drug page


5. Veregen

Veregen is protected by 5 patents, out of which 4 have expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US7858662 Medicament for the treatment of viral skin and tumour diseases 02 Oct, 2026
(6 months from now)
Active
US9770406 Medicament for the treatment of viral skin and tumour diseases 12 Jul, 2025
(8 months ago)
Expired
US10434059 Medicament for the treatment of viral skin and tumour diseases 18 Nov, 2022
(3 years ago)
Expired
US5795911 Composition for treating Condyloma acuminata 31 Oct, 2020
(5 years ago)
Expired
US5968973 Method for treating hyperplasia 10 Apr, 2017
(8 years ago)
Expired

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 Veregen's drug page


Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List