Impax Drug Patent Portfolio

Impax owns 4 orange book drugs protected by 44 US patents Given below is the list of Impax's drug patents along with their expiration dates.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US11986449 Levodopa dosing regimen 21 Dec, 2041
Active
US12109185 Levodopa dosing regimen 21 Dec, 2041
Active
US12194150 Levodopa dosing regimen 21 Dec, 2041
Active
US12201596 Levodopa dosing regimen 21 Dec, 2041
Active
US12263148 Levodopa dosing regimen 21 Dec, 2041
Active
US12263149 Levodopa dosing regimen 21 Dec, 2041
Active
US12295931 Levodopa dosing regimen 21 Dec, 2041
Active
US12303481 Levodopa dosing regimen 21 Dec, 2041
Active
US12303482 Levodopa dosing regimen 21 Dec, 2041
Active
US12370163 Levodopa Dosing Regimen 21 Dec, 2041
Active
US12447139 Levodopa Dosing Regimen 21 Dec, 2041
Active
US12453710 Levodopa Dosing Regimen 21 Dec, 2041
Active
US12458616 Levodopa Dosing Regimen 21 Dec, 2041
Active
US10098845 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US10292935 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US10688058 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US10973769 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US10987313 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US11357733 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US11622941 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US11666538 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US12064521 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US12128141 Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US12178918 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US12178919 Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US12274793 Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US12303605 Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
Active
US12403099 Muco-Adhesive, Controlled Release Formulation Of Levodopa And/Or Esters Of Levodopa And Uses Thereof 07 Oct, 2034
Active
US12491164 Muco-Adhesive, Controlled Release Formulation Of Levodopa And/Or Esters Of Levodopa And Uses Thereof 07 Oct, 2034
Active
US8377474 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
Active
US8454998 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
Active
US8557283 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
Active
US9089607 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
Active
US9089608 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
Active
US9463246 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
Active
US9533046 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
Active
US9901640 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
Active
US7905352 Kits containing medicine injection devices and containers 12 Apr, 2027
Active
US7621891 Method and apparatus for delivering epinephrine 04 Feb, 2025 Expired
US10166334 Medicine injection apparatuses 21 Jan, 2025 Expired
US10166344 Injection needle assembly 21 Jan, 2025 Expired
US7297136 Medicine injection devices and methods 18 Jan, 2025 Expired
US7094427 Combination immediate release controlled release levodopa/carbidopa dosage forms 29 May, 2022 Expired
US5665071 Reloadable automatic or manual emergency injection system 27 May, 2013 Expired


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

Activity Date Patent Number
Patent litigations
Dispatch to FDC 24 Sep, 2025 US12447139
Application Is Considered Ready for Issue 24 Sep, 2025 US12447139
Application Is Considered Ready for Issue 23 Sep, 2025 US12453710
Dispatch to FDC 23 Sep, 2025 US12453710
Issue Fee Payment Verified 22 Sep, 2025 US12453710
Amendment after Notice of Allowance (Rule 312) 22 Sep, 2025 US12491164
Issue Fee Payment Verified 22 Sep, 2025 US12447139
Issue Fee Payment Received 22 Sep, 2025 US12447139
Issue Fee Payment Received 22 Sep, 2025 US12453710
Email Notification 17 Sep, 2025 US12491164
Mail Notice of Allowance 17 Sep, 2025 US12491164
Notice of Allowance Data Verification Completed 16 Sep, 2025 US12491164
Recordation of Patent Grant Mailed 09 Sep, 2025 US12403099
Patent Issue Date Used in PTA Calculation 02 Sep, 2025 US12403099
Patent eGrant Notification 02 Sep, 2025 US12403099


Impax Drug Patents' Oppositions Filed in EPO

Impax drug patents have faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 07, 2021, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP08866933A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP08866933A Jan, 2021 Luigi, Rumi Granted and Under Opposition
EP08866933A Jan, 2021 Teva Pharmaceutical Industries Ltd. Granted and Under Opposition


Impax's Family Patents

Impax drugs have patent protection in a total of 18 countries. It's US patent count contributes only to 37.8% of its total global patent coverage. 3 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 Impax

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
Duloxetine Hydrochloride ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 18 Nov, 2010
Venlafaxine Hydrochloride ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 16 Oct, 2007
Oxycodone Hydrochloride ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 04 Sep, 2003

Impax Drug List

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


1. Adrenaclick

Adrenaclick is protected by 4 patents, out of which 3 have expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US7905352 Kits containing medicine injection devices and containers 12 Apr, 2027
(1 year, 13 days from now)
Active
US10166334 Medicine injection apparatuses 21 Jan, 2025
(1 year, 2 months ago)
Expired
US10166344 Injection needle assembly 21 Jan, 2025
(1 year, 2 months ago)
Expired
US5665071 Reloadable automatic or manual emergency injection system 27 May, 2013
(12 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 Adrenaclick's drug page


2. Crexont

Crexont is protected by 29 patents, out of which none have expired yet. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US11986449 Levodopa dosing regimen 21 Dec, 2041
(15 years from now)
Active
US12109185 Levodopa dosing regimen 21 Dec, 2041
(15 years from now)
Active
US12194150 Levodopa dosing regimen 21 Dec, 2041
(15 years from now)
Active
US12201596 Levodopa dosing regimen 21 Dec, 2041
(15 years from now)
Active
US12263148 Levodopa dosing regimen 21 Dec, 2041
(15 years from now)
Active
US12263149 Levodopa dosing regimen 21 Dec, 2041
(15 years from now)
Active
US12295931 Levodopa dosing regimen 21 Dec, 2041
(15 years from now)
Active
US12303481 Levodopa dosing regimen 21 Dec, 2041
(15 years from now)
Active
US12303482 Levodopa dosing regimen 21 Dec, 2041
(15 years from now)
Active
US12370163 Levodopa Dosing Regimen 21 Dec, 2041
(15 years from now)
Active
US12447139 Levodopa Dosing Regimen 21 Dec, 2041
(15 years from now)
Active
US12453710 Levodopa Dosing Regimen 21 Dec, 2041
(15 years from now)
Active
US12458616 Levodopa Dosing Regimen 21 Dec, 2041
(15 years from now)
Active
US10098845 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US10292935 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US10688058 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US10973769 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US10987313 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US11357733 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US11622941 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US11666538 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US12064521 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US12128141 Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US12178918 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US12178919 Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US12274793 Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US12303605 Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof 07 Oct, 2034
(8 years from now)
Active
US12403099 Muco-Adhesive, Controlled Release Formulation Of Levodopa And/Or Esters Of Levodopa And Uses Thereof 07 Oct, 2034
(8 years from now)
Active
US12491164 Muco-Adhesive, Controlled Release Formulation Of Levodopa And/Or Esters Of Levodopa And Uses Thereof 07 Oct, 2034
(8 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 Crexont's drug page


3. Rytary

Rytary is protected by 9 patents, out of which 1 has expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US8377474 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
(2 years from now)
Active
US8454998 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
(2 years from now)
Active
US8557283 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
(2 years from now)
Active
US9089607 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
(2 years from now)
Active
US9089608 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
(2 years from now)
Active
US9463246 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
(2 years from now)
Active
US9533046 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
(2 years from now)
Active
US9901640 Controlled release formulations of levodopa and uses thereof 26 Dec, 2028
(2 years from now)
Active
US7094427 Combination immediate release controlled release levodopa/carbidopa dosage forms 29 May, 2022
(3 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 Rytary's drug page


4. Twinject

Twinject is protected by 2 patents, out of which all have expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US7621891 Method and apparatus for delivering epinephrine 04 Feb, 2025
(1 year, 1 month ago)
Expired
US7297136 Medicine injection devices and methods 18 Jan, 2025
(1 year, 2 months 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 Twinject's drug page


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