Carbidopa; Levodopa Patent Expiration

Carbidopa; Levodopa is Used for treating Parkinson's disease and related conditions such as post-encephalitic parkinsonism and parkinsonism from carbon monoxide or manganese intoxication. It was first introduced by Organon Llc A Sub Of Organon And Co in its drug Sinemet on Approved Prior to Jan 1, 1982. Other drugs containing Carbidopa; Levodopa are Rytary, Dhivy, Duopa, Sinemet Cr, Crexont. 27 different companies have introduced drugs containing Carbidopa; Levodopa.


Carbidopa; Levodopa Patents

Given below is the list of patents protecting Carbidopa; Levodopa, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Crexont US11986449 Levodopa dosing regimen Dec 21, 2041 Impax
Dhivy US11033521 Levodopa fractionated dose composition and use Mar 28, 2039 Avion Pharms
Dhivy US11439613 Levodopa fractionated dose composition and use Mar 28, 2039 Avion Pharms
Dhivy US11819485 Levodopa fractionated dose composition and use Mar 28, 2039 Avion Pharms
Crexont US10098845 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Oct 07, 2034 Impax
Crexont US10292935 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Oct 07, 2034 Impax
Crexont US10688058 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Oct 07, 2034 Impax
Crexont US10973769 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Oct 07, 2034 Impax
Crexont US10987313 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Oct 07, 2034 Impax
Crexont US11357733 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Oct 07, 2034 Impax
Crexont US11622941 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Oct 07, 2034 Impax
Crexont US11666538 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Oct 07, 2034 Impax
Crexont US12064521 Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Oct 07, 2034 Impax
Rytary US8377474 Controlled release formulations of levodopa and uses thereof Dec 26, 2028 Impax
Rytary US8454998 Controlled release formulations of levodopa and uses thereof Dec 26, 2028 Impax
Rytary US8557283 Controlled release formulations of levodopa and uses thereof Dec 26, 2028 Impax
Rytary US9089607 Controlled release formulations of levodopa and uses thereof Dec 26, 2028 Impax
Rytary US9089608 Controlled release formulations of levodopa and uses thereof Dec 26, 2028 Impax
Rytary US9463246 Controlled release formulations of levodopa and uses thereof Dec 26, 2028 Impax
Rytary US9533046 Controlled release formulations of levodopa and uses thereof Dec 26, 2028 Impax
Rytary US9901640 Controlled release formulations of levodopa and uses thereof Dec 26, 2028 Impax
Rytary US7094427 Combination immediate release controlled release levodopa/carbidopa dosage forms May 29, 2022

(Expired)

Impax



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Carbidopa; Levodopa's patents.

Given below is the list recent legal activities going on the following patents of Carbidopa; Levodopa.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 03 Jul, 2024 US9533046
Payment of Maintenance Fee, 8th Year, Large Entity 11 Apr, 2024 US9463246(Litigated)
Email Notification 24 May, 2023 US8377474(Litigated)
Change in Power of Attorney (May Include Associate POA) 24 May, 2023 US8377474(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 30 Jan, 2023 US9089607(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 30 Jan, 2023 US9089608(Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 11 Aug, 2021 US9901640
Payment of Maintenance Fee, 8th Year, Large Entity 31 Mar, 2021 US8557283(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 25 Sep, 2020 US8454998(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 06 Aug, 2020 US8377474(Litigated)


Carbidopa; Levodopa's Family Patents

Family Patents

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Carbidopa; Levodopa Generics

Several generic applications have been filed for Carbidopa; Levodopa. The first generic version for Carbidopa; Levodopa was by Dr Reddys Laboratories Sa and was approved on Aug 28, 1992. And the latest generic version is by Rubicon Research Private Ltd and was approved on Jun 4, 2024.

Given below is the list of companies who have filed for Carbidopa; Levodopa generic.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 2 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG; 100MG tablet, extended release Prescription ORAL AB Feb 8, 2013
50MG; 200MG tablet, extended release Prescription ORAL AB Feb 8, 2013


2. ACTAVIS ELIZABETH

Actavis Elizabeth Llc has filed for 3 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Actavis Elizabeth.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG; 250MG

(reference standard)

tablet Prescription ORAL AB Sep 3, 1993
25MG; 100MG tablet Prescription ORAL AB Sep 3, 1993
10MG; 100MG tablet Prescription ORAL AB Sep 3, 1993


3. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG; 100MG tablet, extended release Prescription ORAL AB Jun 5, 2019
50MG; 200MG tablet, extended release Prescription ORAL AB Jun 5, 2019


4. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 3 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Ani Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG; 100MG tablet Discontinued ORAL N/A Jun 29, 1995
25MG; 100MG tablet Discontinued ORAL N/A Jun 29, 1995
25MG; 250MG tablet Discontinued ORAL N/A Jun 29, 1995


5. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG; 200MG tablet, extended release Prescription ORAL AB Jun 16, 2004
25MG; 100MG tablet, extended release Prescription ORAL AB Jun 16, 2004


6. APOTEX INC

Apotex Inc has filed for 3 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Apotex Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG; 250MG tablet Prescription ORAL AB Jun 2, 2008
10MG; 100MG tablet Prescription ORAL AB Jun 2, 2008
25MG; 100MG tablet Prescription ORAL AB Jun 2, 2008


7. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG; 100MG tablet Prescription ORAL AB Nov 28, 2022
10MG; 100MG tablet Prescription ORAL AB Nov 28, 2022
25MG; 250MG tablet Prescription ORAL AB Nov 28, 2022


8. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 3 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG; 100MG tablet Prescription ORAL AB Aug 28, 1992
25MG; 100MG tablet Prescription ORAL AB Aug 28, 1992
25MG; 250MG tablet Prescription ORAL AB Aug 28, 1992


9. IMPAX LABS

Impax Laboratories Inc has filed for 4 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Impax Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG; 100MG tablet, orally disintegrating Discontinued ORAL N/A Jun 8, 2010
50MG; 200MG tablet, extended release Prescription ORAL AB May 14, 2004
10MG; 100MG tablet, orally disintegrating Discontinued ORAL N/A Jun 8, 2010
25MG; 250MG tablet, orally disintegrating Discontinued ORAL N/A Jun 8, 2010


10. KV PHARM

Kv Pharmaceutical Co has filed for 1 generic for Carbidopa; Levodopa. This 50mg;200mg version comes by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Kv Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG; 200MG tablet, extended release Discontinued ORAL N/A Jun 24, 2004


11. MYLAN

Mylan Pharmaceuticals Inc has filed for 4 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG; 200MG tablet, extended release Prescription ORAL AB Sep 30, 1999
25MG; 100MG tablet Prescription ORAL AB Sep 28, 2009
10MG; 100MG tablet Prescription ORAL AB Sep 28, 2009
25MG; 250MG tablet Prescription ORAL AB Sep 28, 2009


12. RANBAXY

Ranbaxy Laboratories Ltd has filed for 3 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBILEV. Given below are the details of the strengths of this generic introduced by Ranbaxy.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG; 100MG tablet, for suspension Discontinued ORAL N/A Jun 10, 2005
25MG; 250MG tablet, for suspension Discontinued ORAL N/A Jun 10, 2005
25MG; 100MG tablet, for suspension Discontinued ORAL N/A Jun 10, 2005


13. RISING

Rising Pharma Holding Inc has filed for 3 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG; 250MG tablet, orally disintegrating Discontinued ORAL N/A Sep 18, 2008
10MG; 100MG tablet, orally disintegrating Discontinued ORAL N/A Sep 18, 2008
25MG; 100MG tablet, orally disintegrating Discontinued ORAL N/A Sep 18, 2008


14. RUBICON

Rubicon Research Private Ltd has filed for 4 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Rubicon.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG; 100MG tablet Prescription ORAL AB Sep 21, 2022
25MG; 250MG tablet Prescription ORAL AB Sep 21, 2022
25MG; 100MG tablet, extended release Prescription ORAL AB Jun 4, 2024
50MG; 200MG tablet, extended release Prescription ORAL AB Jun 4, 2024


15. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG; 100MG tablet Discontinued ORAL N/A Jun 29, 1995
25MG; 250MG tablet Discontinued ORAL N/A Jun 29, 1995


16. SCIEGEN PHARMS INC

Sciegen Pharmaceuticals Inc has filed for 4 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Sciegen Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG; 100MG tablet Prescription ORAL AB May 7, 2021
25MG; 250MG tablet Prescription ORAL AB May 7, 2021
25MG; 100MG tablet, extended release Prescription ORAL AB Oct 5, 2021
50MG; 200MG

(reference standard)

tablet, extended release Prescription ORAL AB Oct 5, 2021


17. SCS

Scs Pharmaceuticals has filed for 3 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Scs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG; 100MG tablet Discontinued ORAL N/A Mar 25, 1994
25MG; 250MG tablet Discontinued ORAL N/A Mar 25, 1994
25MG; 100MG tablet Discontinued ORAL N/A Mar 25, 1994


18. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG; 100MG tablet, orally disintegrating Prescription ORAL N/A Jul 31, 2009
25MG; 250MG

(reference standard)

tablet, orally disintegrating Prescription ORAL N/A Jul 31, 2009
10MG; 100MG tablet, orally disintegrating Prescription ORAL N/A Jul 31, 2009


19. SUN PHARM INDS

Sun Pharmaceutical Industries Ltd has filed for 4 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG; 100MG tablet Prescription ORAL AB Oct 28, 2008
50MG; 200MG tablet, extended release Prescription ORAL AB Aug 23, 2007
25MG; 250MG tablet Prescription ORAL AB Oct 28, 2008
10MG; 100MG tablet Prescription ORAL AB Oct 28, 2008


20. UCB INC

Ucb Inc has filed for 3 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name PARCOPA. Given below are the details of the strengths of this generic introduced by Ucb Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** tablet, orally disintegrating Discontinued ORAL N/A Aug 27, 2004
25MG; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** tablet, orally disintegrating Discontinued ORAL N/A Aug 27, 2004
25MG; 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** tablet, orally disintegrating Discontinued ORAL N/A Aug 27, 2004


21. WATSON LABS

Watson Laboratories Inc has filed for 3 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG; 250MG tablet Discontinued ORAL N/A Sep 28, 1993
10MG; 100MG tablet Discontinued ORAL N/A Sep 28, 1993
25MG; 100MG tablet Discontinued ORAL N/A Sep 28, 1993


22. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Carbidopa; Levodopa. All of these versions come by the name CARBIDOPA AND LEVODOPA. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG; 100MG tablet Discontinued ORAL N/A Apr 4, 2023
25MG; 250MG tablet Discontinued ORAL N/A Apr 4, 2023
10MG; 100MG tablet Discontinued ORAL N/A Apr 4, 2023