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Prednisolone Sodium Phosphate Patent Expiration

Prednisolone Sodium Phosphate was first introduced by Merck And Co Inc in its drug Hydeltrasol on Approved Prior to Jan 1, 1982. Other drugs containing Prednisolone Sodium Phosphate are Orapred Odt, Pediapred. 26 different companies have introduced drugs containing Prednisolone Sodium Phosphate.


Prednisolone Sodium Phosphate Patents

Given below is the list of patents protecting Prednisolone Sodium Phosphate, 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
Orapred Odt US6740341 Taste masking rapid release coating system Nov 24, 2019

(Expired)

 Concordia Pharms Inc
Orapred Odt US6024981 Rapidly dissolving robust dosage form Apr 09, 2018

(Expired)

 Concordia Pharms Inc
Orapred Odt US6221392 Rapidly dissolving robust dosage form Apr 09, 2018

(Expired)

 Concordia Pharms Inc



Prednisolone Sodium Phosphate's Family Patents

Family Patents

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Prednisolone Sodium Phosphate Generic API Manufacturers

Several generic applications have been filed for Prednisolone Sodium Phosphate. The first generic version for Prednisolone Sodium Phosphate was by Novartis Pharmaceuticals Corp and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Edenbridge Pharmaceuticals Llc and was approved on Feb 6, 2023.

Given below is the list of companies who have filed for Prednisolone Sodium Phosphate generic, along with the locations of their manufacturing plants worldwide.


1. ALCON PHARMS LTD

Alcon Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Alcon Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.11% PHOSPHATE

solution/drops Discontinued OPHTHALMIC N/A Oct 24, 1991
EQ 0.9% PHOSPHATE

solution/drops Discontinued OPHTHALMIC N/A Oct 24, 1991





2. AMNEAL

Amneal Pharmaceuticals Llc has filed for 1 generic for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 15MG BASE/5ML

solution Prescription ORAL AA Oct 25, 2022


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Piscataway Amneal Pharmaceuticals, LLC
Branchburg Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited





3. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 1 generic for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 15MG BASE/5ML

solution Discontinued ORAL N/A Mar 10, 2009





4. BAUSCH

Bausch Health Us Llc has filed for 1 generic for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Bausch.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 15MG BASE/5ML

solution Discontinued ORAL N/A Jul 12, 2002


Manufacturing Plant Locations
New

Bausch's manufacturing plants are situated in 2 countries - United States, Canada. Given below are the details of these plant locations as well as the firm names of Bausch as present at those locations.

Country City Firm Name
United States
Bridgewater Bausch and Lomb, Inc
Rochester Bausch Health Americas, Inc.
Irvine Bausch and Lomb, Incorporated
Rochester Bausch & Lomb Incorporated
Saint Louis Bausch & Lomb Inc
Petaluma Bausch Health Americas, Inc.
Woodruff Bausch & Lomb Inc
Wilmington Bausch & Lomb Incorporated
Rancho Cucamonga Bausch and Lomb, Incorporated
Bridgewater Bausch Health Companies, Inc.
Lancaster Bausch & Lomb Incorporated
Manchester Bausch & Lomb, Inc.
Greenville Bausch & Lomb Incorporated
Canada
Steinbach Bausch Health Companies Inc.
Laval Bausch Health Companies Inc.





5. BAUSCH AND LOMB

Bausch And Lomb Pharmaceuticals Inc has filed for 2 different strengths of generic version for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Bausch And Lomb.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.11% PHOSPHATE

solution/drops Discontinued OPHTHALMIC N/A Jul 29, 1994
EQ 0.9% PHOSPHATE

(reference standard)

solution/drops Prescription OPHTHALMIC N/A Jul 29, 1994


Manufacturing Plant Locations
New

Bausch And Lomb's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Bausch And Lomb as present at those locations.

Country City Firm Name
United States
Bridgewater Bausch and Lomb, Inc
Rancho Cucamonga Bausch and Lomb, Incorporated
Irvine Bausch and Lomb, Incorporated





6. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Prednisolone Sodium Phosphate. 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
EQ 5MG BASE/5ML

solution Prescription ORAL AA May 25, 2004





7. CONCORDIA PHARMS INC

Concordia Pharmaceuticals Inc has filed for 1 generic for Prednisolone Sodium Phosphate. This eq 15mg base/5ml **federal register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** version comes by the name ORAPRED. Given below are the details of the strengths of this generic introduced by Concordia Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 15MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

solution Discontinued ORAL N/A Dec 14, 2000





8. EDENBRIDGE PHARMS

Edenbridge Pharmaceuticals Llc has filed for 4 different strengths of generic version for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Edenbridge Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 10MG BASE/5ML

solution Prescription ORAL AA Dec 20, 2016
EQ 20MG BASE/5ML

solution Prescription ORAL AA Dec 20, 2016
EQ 15MG BASE/5ML

solution Prescription ORAL AA Feb 6, 2023
EQ 25MG BASE/5ML

solution Prescription ORAL AA Feb 6, 2023





9. ENDO OPERATIONS

Endo Operations Ltd has filed for 1 generic for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 15MG BASE/5ML

solution Discontinued ORAL N/A May 26, 2009





10. EPIC PHARMA LLC

Epic Pharma Llc has filed for 2 different strengths of generic version for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.9% PHOSPHATE

solution/drops Discontinued OPHTHALMIC N/A Approved Prior to Jan 1, 1982
EQ 0.11% PHOSPHATE

solution/drops Discontinued OPHTHALMIC N/A Approved Prior to Jan 1, 1982





11. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Hikma.

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

solution Discontinued ORAL N/A Mar 26, 2003


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





12. MISSION PHARMA

Mission Pharmacal Co has filed for 1 generic for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Mission Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 25MG BASE/5ML

(reference standard)

solution Prescription ORAL AA Sep 13, 2010


Manufacturing Plant Locations
New

Mission Pharma's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Mission Pharma as present at those locations.

Country City Firm Name
United States
Boerne Mission Pharmacal Company
San Antonio Mission Pharmacal Co





13. NESHER PHARMS

Nesher Pharmaceuticals Usa Llc has filed for 2 different strengths of generic version for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Nesher Pharms.

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

solution Discontinued ORAL N/A May 24, 2005
EQ 15MG BASE/5ML

solution Discontinued ORAL N/A May 24, 2005





14. NOVARTIS

Novartis Pharmaceuticals Corp has filed for 2 different strengths of generic version for Prednisolone Sodium Phosphate. Out of these eq 0.9% phosphate version comes by the name INFLAMASE FORTE, eq 0.11% phosphate version comes by the name INFLAMASE MILD. Given below are the details of the strengths of this generic introduced by Novartis.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.9% PHOSPHATE

solution/drops Discontinued OPHTHALMIC N/A Approved Prior to Jan 1, 1982
EQ 0.11% PHOSPHATE

solution/drops Discontinued OPHTHALMIC N/A Approved Prior to Jan 1, 1982


Manufacturing Plant Locations
New

Novartis's manufacturing plants are situated in 8 countries - Slovenia, Italy, United States, United Kingdom, India, Switzerland, Germany, France. Given below are the details of these plant locations as well as the firm names of Novartis as present at those locations.

Country City Firm Name
Slovenia
Menges Novartis d.o.o.
Ljubljana Novartis d.o.o.
Italy
Torre Annunziata Novartis Farma S.P.A.
United States
San Diego Novartis Gene Therapies, Inc.
Vacaville Novartis Pharmaceuticals Corporation
Libertyville Novartis Gene Therapies, Inc.
Suffern Novartis Pharmaceuticals Corp.
East Hanover Novartis Pharmaceuticals Corporation
Morris Plains Novartis Pharmaceuticals Corporation
Durham Novartis Gene Therapies Inc.
Broomfield Novartis Pharmaceuticals A. G.
Indianapolis Novartis Pharmaceutical Corporation
United Kingdom
Grimsby Novartis Grimsby Limited
India
Shaikpet Novartis Healthcare Pvt. Ltd.
Thane Novartis Healthcare Private, Limited
Switzerland
Pratteln Novartis Pharma Schweizerhalle Ag
Stein Ag Novartis Pharma Stein AG
Basel Novartis Pharma AG
Germany
Wehr Novartis Pharma Produktions GmbH
France
Huningue Novartis Pharma S.A.S. - Centre de Biotechnologie





15. PHARM ASSOC

Pharmaceutical Associates Inc has filed for 5 different strengths of generic version for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Pharm Assoc.

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

solution Discontinued ORAL N/A Dec 23, 2002
EQ 15MG BASE/5ML

(reference standard)

solution Prescription ORAL AA Apr 25, 2005
EQ 10MG BASE/5ML

(reference standard)

solution Prescription ORAL AA Mar 7, 2008
EQ 20MG BASE/5ML

(reference standard)

solution Prescription ORAL AA Jun 9, 2008
EQ 30MG BASE/5ML

solution Discontinued ORAL N/A Mar 11, 2020





16. PHARMAFAIR

Pharmafair Inc has filed for 2 different strengths of generic version for Prednisolone Sodium Phosphate. Out of these eq 0.9% phosphate version comes by the name PREDAIR FORTE, eq 0.11% phosphate version comes by the name PREDAIR. Given below are the details of the strengths of this generic introduced by Pharmafair.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.9% PHOSPHATE

solution/drops Discontinued OPHTHALMIC N/A Mar 28, 1983
EQ 0.11% PHOSPHATE

solution/drops Discontinued OPHTHALMIC N/A Feb 29, 1984





17. PHARMOBEDIENT

Pharmobedient Consulting Llc has filed for 1 generic for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Pharmobedient.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 15MG BASE/5ML

solution Discontinued ORAL N/A Oct 4, 2004





18. PHARMOBEDIENT CNSLTG

Pharmobedient Consulting has filed for 1 generic for Prednisolone Sodium Phosphate. 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
EQ 5MG BASE/5ML

solution Discontinued ORAL N/A Jun 28, 2002





19. RISING

Rising Pharma Holdings Inc has filed for 3 different strengths of generic version for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 10MG BASE

tablet, orally disintegrating Discontinued ORAL N/A Apr 10, 2013
EQ 15MG BASE

tablet, orally disintegrating Discontinued ORAL N/A Apr 10, 2013
EQ 30MG BASE

tablet, orally disintegrating Discontinued ORAL N/A Apr 10, 2013


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Rising Sun Rising Sun Veterinary Clinic
Fort Bragg Rising Tide Sea Vegetables
Mount Morris Rising Creek Bakery LLC
Decatur Rising Pharma Holdings, Inc
Saddle Brook Rising Pharmaceuticals, Inc.
East Brunswick Rising Pharma Holding, Inc.
Livingston Risingsun Iodine Products Corp.
Phoenix Rising Sun Farms Inc
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





20. SCHERING

Schering Corp Sub Schering Plough Corp has filed for 1 generic for Prednisolone Sodium Phosphate. This eq 0.5% phosphate version comes by the name METRETON. Given below are the details of the strengths of this generic introduced by Schering.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% PHOSPHATE

solution/drops Discontinued OPHTHALMIC N/A Approved Prior to Jan 1, 1982


Manufacturing Plant Locations
New

Schering's manufacturing plants are situated in 2 countries - Ireland, United Kingdom. Given below are the details of these plant locations as well as the firm names of Schering as present at those locations.

Country City Firm Name
Ireland
Wicklow Schering-Plough (Avondale) Company
Bray Schering-Plough (Bray) Ltd.
United Kingdom
Welwyn Garden City Schering-Plough Ltd





21. SOLA BARNES HIND

Sola Barnes Hind has filed for 2 different strengths of generic version for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Sola Barnes Hind.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.9% PHOSPHATE

solution/drops Discontinued OPHTHALMIC N/A Approved Prior to Jan 1, 1982
EQ 0.11% PHOSPHATE

solution/drops Discontinued OPHTHALMIC N/A Approved Prior to Jan 1, 1982





22. VINTAGE PHARMS

Vintage Pharmaceuticals has filed for 1 generic for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by Vintage Pharms.

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

solution Discontinued ORAL N/A Oct 31, 2007





23. WATSON LABS

Watson Laboratories Inc has filed for 1 generic for Prednisolone Sodium Phosphate. 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
EQ 20MG PHOSPHATE/ML

injectable Discontinued INJECTION N/A Approved Prior to Jan 1, 1982





24. WE PHARMS

We Pharmaceuticals Inc has filed for 1 generic for Prednisolone Sodium Phosphate. Given below are the details of the strengths of this generic introduced by We Pharms.

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

solution Discontinued ORAL N/A Dec 23, 2002