Dexamethasone Patent Expiration

Dexamethasone is Used for treating eye conditions such as diabetic macular edema, macular edema, non-infectious uveitis, and uveitis by delivering an ocular implant. It was first introduced by Merck And Co Inc in its drug Decadron on Approved Prior to Jan 1, 1982. Other drugs containing Dexamethasone are Hemady, Decaspray, Decaderm, Dexycu Kit, Ozurdex, Hexadrol, Maxidex, Dextenza. 36 different companies have introduced drugs containing Dexamethasone.


Dexamethasone Patents

Given below is the list of patents protecting Dexamethasone, 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
Dextenza US11458041 Punctal plug and bioadhesives Nov 16, 2037 Ocular Therapeutix
Dextenza US8409606 Drug delivery through hydrogel plugs May 14, 2030 Ocular Therapeutix
Dextenza US8563027 Drug delivery through hydrogel plugs Feb 12, 2030 Ocular Therapeutix
Dextenza US9254267 Composite hydrogel drug delivery systems Sep 11, 2024 Ocular Therapeutix
Dexycu Kit US10022502 Dose guides for injection syringe Jun 22, 2034 Eyepoint Pharms
Dexycu Kit US10028965 Use of sustained release dexamethasone in post-cataract surgery inflammation May 23, 2034 Eyepoint Pharms
Dexycu Kit US10159683 Use of sustained release dexamethasone in post-cataract surgery inflammation May 23, 2034 Eyepoint Pharms
Dexycu Kit US10799642 Dose guides for injection syringe May 11, 2032 Eyepoint Pharms
Dexycu Kit US11097061 Systems, kits and methods for loading and delivering a small volume dose from a syringe Jun 23, 2039 Eyepoint Pharms
Dexycu Kit US6960346 Vehicles for delivery of biologically active substances Jul 03, 2023

(Expired)

Eyepoint Pharms
Dexycu Kit US7560120 Vehicles for delivery of biologically active substances Sep 05, 2022

(Expired)

Eyepoint Pharms
Hemady US10537585 Compositions comprising dexamethasone Dec 18, 2037 Dexcel
Hemady US11304961 Compositions comprising dexamethasone Dec 18, 2037 Dexcel
Ozurdex US10076526 Ocular implant made by a double extrusion process Jan 09, 2023

(Expired)

Abbvie
Ozurdex US10702539 Ocular implant made by a double extrusion process Jan 09, 2023

(Expired)

Abbvie
Ozurdex US6726918 Methods for treating inflammation-mediated conditions of the eye Oct 20, 2020

(Expired)

Abbvie
Ozurdex US6899717 Methods and apparatus for delivery of ocular implants Nov 01, 2023

(Expired)

Abbvie
Ozurdex US7033605 Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor Oct 20, 2020

(Expired)

Abbvie
Ozurdex US7767223 Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use Nov 28, 2021

(Expired)

Abbvie
Ozurdex US8034366 Ocular implant made by a double extrusion process Jan 09, 2023

(Expired)

Abbvie
Ozurdex US8034370 Ocular implant made by a double extrusion process Jan 09, 2023

(Expired)

Abbvie
Ozurdex US8043628 Methods for reducing edema Oct 20, 2020

(Expired)

Abbvie
Ozurdex US8063031 Implants and methods for treating inflammation-mediated conditions of the eye Oct 20, 2020

(Expired)

Abbvie
Ozurdex US8088407 Method for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor Oct 20, 2020

(Expired)

Abbvie
Ozurdex US8506987 Ocular implant made by a double extrusion process Jan 09, 2023

(Expired)

Abbvie
Ozurdex US9012437 Implants and methods for treating inflammation-mediated conditions of the eye Oct 20, 2020

(Expired)

Abbvie
Ozurdex US9192511 Ocular implant made by a double extrusion process Jan 09, 2023

(Expired)

Abbvie
Ozurdex US9283178 Methods for treating edema in the eye and intraocular implants for use therefor Oct 20, 2020

(Expired)

Abbvie
Ozurdex US9592242 Methods for treating edema in the eye and intraocular implants for use therefor Oct 20, 2020

(Expired)

Abbvie
Ozurdex US9775849 Implants and methods for treating inflammation-mediated conditions of the eye Oct 20, 2020

(Expired)

Abbvie


Coming Soon

Patent Strength Analyzer

Will this be useful for you?

YesNo

Thank you for your response 🥳

Dexamethasone Generics

Several generic applications have been filed for Dexamethasone. The first generic version for Dexamethasone was by Sun Pharmaceutical Industries Inc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Zydus Lifesciences Ltd and was approved on May 9, 2024.

Given below is the list of companies who have filed for Dexamethasone generic.


1. AMNEAL

Amneal Eu Ltd has filed for 3 different strengths of generic version for Dexamethasone. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG tablet Prescription ORAL AB Oct 14, 2021
6MG tablet Prescription ORAL AB Oct 14, 2021
2MG tablet Prescription ORAL AB Sep 8, 2022


2. IMPAX LABS

Impax Laboratories Inc has filed for 1 generic for Dexamethasone. 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
0.75MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982


3. ALPHARMA US PHARMS

Alpharma Us Pharmaceuticals Division has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Alpharma Us Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG/5ML elixir Discontinued ORAL N/A Oct 10, 1986


4. APOTEX

Apotex Inc has filed for 7 different strengths of generic version for Dexamethasone. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG tablet Prescription ORAL AB Aug 23, 2023
6MG tablet Prescription ORAL AB Aug 23, 2023
4MG tablet Prescription ORAL AB Aug 23, 2023
2MG tablet Prescription ORAL AB Aug 23, 2023
0.5MG tablet Prescription ORAL AB Aug 23, 2023
0.75MG tablet Prescription ORAL AB Aug 23, 2023
1MG tablet Prescription ORAL AB Aug 23, 2023


5. PHOENIX LABS NY

Phoenix Laboratories Inc has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Phoenix Labs Ny.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982


6. PRASCO

Prasco Llc Dba Prasco Laboratories has filed for 2 different strengths of generic version for Dexamethasone. Given below are the details of the strengths of this generic introduced by Prasco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
4MG tablet Prescription ORAL AB Apr 20, 2022


7. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 9 different strengths of generic version for Dexamethasone. Out of these 1mg/ml version comes by the name DEXAMETHASONE INTENSOL. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG

(reference listed drug)

tablet Prescription ORAL AB Approved Prior to Jan 1, 1982
0.5MG

(reference listed drug)

tablet Prescription ORAL AB Approved Prior to Jan 1, 1982
4MG

(reference listed drug)

tablet Prescription ORAL AB Approved Prior to Jan 1, 1982
0.75MG

(reference listed drug)

tablet Prescription ORAL AB Approved Prior to Jan 1, 1982
2MG

(reference standard)

(reference listed drug)

tablet Prescription ORAL AB Aug 26, 1982
0.5MG/5ML

(reference standard)

(reference listed drug)

solution Prescription ORAL N/A Sep 1, 1983
1MG/ML

(reference standard)

concentrate Prescription ORAL N/A Sep 1, 1983
6MG

(reference standard)

(reference listed drug)

tablet Prescription ORAL AB Sep 15, 1983
1MG

(reference standard)

(reference listed drug)

tablet Prescription ORAL AB Sep 15, 1983


8. WATSON LABS

Watson Laboratories Inc has filed for 5 different strengths of generic version for Dexamethasone. 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
0.75MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
0.25MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
0.5MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
1.5MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
0.1% suspension/drops Discontinued OPHTHALMIC N/A May 9, 1989


9. ZYDUS LIFESCIENCES

Zydus Lifesciences Ltd has filed for 7 different strengths of generic version for Dexamethasone. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75MG tablet Prescription ORAL AB Feb 7, 2024
0.5MG tablet Prescription ORAL AB Feb 7, 2024
4MG tablet Prescription ORAL AB Feb 7, 2024
6MG tablet Prescription ORAL AB Feb 7, 2024
2MG tablet Prescription ORAL AB Feb 7, 2024
1.5MG tablet Prescription ORAL AB Feb 7, 2024
1MG tablet Prescription ORAL AB May 9, 2024


10. KEY THERAP

Key Therapeutics Llc has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Key Therap.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG tablet Discontinued ORAL N/A Apr 28, 1983


11. ALLERGAN HERBERT

Allergan Herbert Div Allergan Inc has filed for 1 generic for Dexamethasone. This 0.01% **federal register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** version comes by the name AEROSEB-DEX. Given below are the details of the strengths of this generic introduced by Allergan Herbert.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** aerosol Discontinued TOPICAL N/A Approved Prior to Jan 1, 1982


12. SOLVAY

Solvay Pharmaceuticals has filed for 4 different strengths of generic version for Dexamethasone. Out of these 1.5mg version comes by the name DEXONE 1.5, 0.5mg version comes by the name DEXONE 0.5, 4mg version comes by the name DEXONE 4, 0.75mg version comes by the name DEXONE 0.75. Given below are the details of the strengths of this generic introduced by Solvay.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
0.5MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
4MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
0.75MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982


13. WHITEWORTH TOWN PLSN

Whiteworth Towne Paulsen Inc has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Whiteworth Town Plsn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982


14. UPSHER SMITH

Upsher Smith Laboratories Inc has filed for 2 different strengths of generic version for Dexamethasone. Given below are the details of the strengths of this generic introduced by Upsher Smith.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
0.75MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982


15. BIONPHARMA

Bionpharma Inc has filed for 3 different strengths of generic version for Dexamethasone. Given below are the details of the strengths of this generic introduced by Bionpharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG tablet Prescription ORAL AB Apr 19, 2023
4MG tablet Prescription ORAL AB Apr 19, 2023
2MG tablet Prescription ORAL AB Apr 26, 2023


16. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982


17. ROXANE

Roxane Laboratories Inc has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Roxane.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982


18. PANGEA

Pangea Pharmaceuticals Llc has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Pangea.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25MG tablet Discontinued ORAL N/A Apr 28, 1983


19. LYNE

Lyne Laboratories Inc has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Lyne.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG/5ML elixir Prescription ORAL AA Jul 12, 2011


20. BAUSCH

Bausch Health Americas Inc has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Bausch.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG tablet Discontinued ORAL N/A Aug 15, 2008


21. SUN PHARM INDUSTRIES

Sun Pharmaceutical Industries Inc has filed for 4 different strengths of generic version for Dexamethasone. Given below are the details of the strengths of this generic introduced by Sun Pharm Industries.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
0.25MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
0.5MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
1.5MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982


22. ALVOGEN

Alvogen Inc has filed for 4 different strengths of generic version for Dexamethasone. Given below are the details of the strengths of this generic introduced by Alvogen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75MG tablet Prescription ORAL BP Apr 28, 1983
0.5MG tablet Prescription ORAL BP Apr 28, 1983
4MG tablet Prescription ORAL AB Apr 28, 1983
6MG tablet Prescription ORAL AB Nov 28, 1983


23. LARKEN LABS INC

Larken Laboratories Inc has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Larken Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG tablet Prescription ORAL AB Jul 17, 2017


24. NOVITIUM PHARMA

Novitium Pharma Llc has filed for 6 different strengths of generic version for Dexamethasone. Given below are the details of the strengths of this generic introduced by Novitium Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG tablet Prescription ORAL AB Aug 8, 2022
1.5MG tablet Prescription ORAL AB Aug 8, 2022
6MG tablet Prescription ORAL AB Aug 8, 2022
2MG tablet Prescription ORAL AB May 9, 2023
0.75MG tablet Prescription ORAL AB Oct 5, 2023
0.5MG tablet Prescription ORAL AB Oct 5, 2023


25. PVT FORM

Private Formulations Inc has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Pvt Form.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982


26. CHARTWELL MOLECULAR

Chartwell Molecular Holdings Llc has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Chartwell Molecular.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG/5ML elixir Prescription ORAL AA May 11, 2011


27. ANIMA

Anima Pharmaceuticals Pvt Ltd has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Anima.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG/5ML

(reference standard)

elixir Prescription ORAL AA Approved Prior to Jan 1, 1982


28. PAR PHARM

Par Pharmaceutical Inc has filed for 3 different strengths of generic version for Dexamethasone. Given below are the details of the strengths of this generic introduced by Par Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75MG tablet Prescription ORAL BP Apr 28, 1983
4MG tablet Prescription ORAL BP Apr 28, 1983
0.5MG tablet Prescription ORAL BP Apr 28, 1983


29. PHARMOBEDIENT CNSLTG

Pharmobedient Consulting has filed for 1 generic for Dexamethasone. Given below are the details of the strengths of this generic introduced by Pharmobedient Cnsltg.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG/5ML

(reference listed drug)

elixir Discontinued ORAL N/A Jul 27, 1983