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Doxercalciferol Patent Expiration

Doxercalciferol is used for managing secondary hyperparathyroidism in chronic kidney disease patients undergoing dialysis. It was first introduced by Sanofi Genzyme in its drug Hectorol on Jun 9, 1999. Another drug containing Doxercalciferol is Doxercalciferol. 14 different companies have introduced drugs containing Doxercalciferol.


Doxercalciferol Patents

Given below is the list of patents protecting Doxercalciferol, 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
Hectorol US7148211 Formulation for lipophilic agents Sep 14, 2023

(Expired)

 Sanofi
Hectorol US6903083 Stabilized hydroxyvitamin D Jul 18, 2021

(Expired)

 Sanofi
Hectorol US5602116 Method for treating and preventing secondary hyperparathyroidism Feb 11, 2014

(Expired)

 Sanofi



Doxercalciferol's Family Patents

Family Patents

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Doxercalciferol Generic API Manufacturers

Several generic applications have been filed for Doxercalciferol. The first generic version for Doxercalciferol was by Hikma Pharmaceuticals Usa Inc and was approved on Sep 23, 2011. And the latest generic version is by Alembic Pharmaceuticals Ltd and was approved on Jun 15, 2023.

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


1. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 1 generic for Doxercalciferol. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MCG/2ML (2MCG/ML)

injectable Prescription INJECTION AP Jun 15, 2023


Manufacturing Plant Locations
New

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

Country City Firm Name
India
Vadodara Alembic Pharmaceuticals Ltd
Panelav Alembic Pharmaceuticals Limited
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Vadodara Alembic Pharmaceuticals, Ltd
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited





2. AMNEAL

Amneal Eu Ltd has filed for 2 different strengths of generic version for Doxercalciferol. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MCG/2ML (2MCG/ML)

injectable Discontinued INJECTION N/A May 24, 2017
2MCG/ML (2MCG/ML)

injectable Discontinued INJECTION N/A May 24, 2017


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
Glasgow Amneal Pharmaceuticals LLC
Piscataway 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
Bridgewater Amneal Complex Products Research LLC
Branchburg Amneal Pharmaceuticals, LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Hyderabad Amneal Oncology Private Limited
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.





3. AVET

Avet Pharmaceuticals Inc has filed for 3 different strengths of generic version for Doxercalciferol. Given below are the details of the strengths of this generic introduced by Avet.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MCG

capsule Prescription ORAL AB Sep 15, 2020
1MCG

capsule Prescription ORAL AB Sep 15, 2020
0.5MCG

capsule Prescription ORAL AB Sep 15, 2020


Manufacturing Plant Locations
New

Avet'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 Avet as present at those locations.

Country City Firm Name
United States
Bedford Aveta Biomics





4. EPIC PHARMA LLC

Epic Pharma Llc has filed for 2 different strengths of generic version for Doxercalciferol. 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
4MCG/2ML (2MCG/ML)

injectable Discontinued INJECTION N/A May 7, 2015
2MCG/ML (2MCG/ML)

injectable Discontinued INJECTION N/A Mar 28, 2016





5. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 2 different strengths of generic version for Doxercalciferol. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MCG/ML (2MCG/ML)

injectable Prescription INJECTION AP Jan 24, 2022
4MCG/2ML (2MCG/ML)

injectable Prescription INJECTION AP Jan 24, 2022


Manufacturing Plant Locations
New

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

Country City Firm Name
India
Riico Industrial Area EUGIA Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited





6. GLAND

Gland Pharma Ltd has filed for 1 generic for Doxercalciferol. Given below are the details of the strengths of this generic introduced by Gland.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MCG/2ML (2MCG/ML)

injectable Prescription INJECTION AP Sep 26, 2019


Manufacturing Plant Locations
New

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

Country City Firm Name
India
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Aurangabad Gland Chemical Private Limited
Hyderabad Gland Pharma Limited
Parawada, Visakhapatnam Gland Pharma Limited
Visakhapatnam Gland Pharma Limited
Sriperumbudur Gland Chemical Private Limited
Malur Gland Chemicals Pvt Ltd.





7. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Doxercalciferol. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MCG

capsule Discontinued ORAL N/A Sep 23, 2011
4MCG/2ML (2MCG/ML)

injectable Prescription INJECTION AP Aug 30, 2013
1MCG

capsule Discontinued ORAL N/A Jan 14, 2014
2.5MCG

capsule Discontinued ORAL N/A Jan 14, 2014


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.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





8. LUPIN LTD

Lupin Ltd has filed for 1 generic for Doxercalciferol. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MCG/2ML (2MCG/ML)

injectable Prescription INJECTION AP Nov 1, 2018


Manufacturing Plant Locations
New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





9. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Doxercalciferol. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MCG/2ML (2MCG/ML)

injectable Prescription INJECTION AP Feb 7, 2020





10. RISING

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MCG

capsule Prescription ORAL AB Sep 9, 2016
2.5MCG

capsule Prescription ORAL AB Sep 9, 2016
1MCG

capsule Prescription ORAL AB Sep 9, 2016


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





11. SANDOZ

Sandoz Inc has filed for 1 generic for Doxercalciferol. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MCG/2ML (2MCG/ML)

injectable Prescription INJECTION AP May 5, 2014


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Langkampfen Sandoz GmbH
Kundl Sandoz GmbH
United States
East Hanover Sandoz Incorporated
Princeton Sandoz Inc
Spain
Les Franqueses Del Valles Sandoz Industrial Products S.A.
Palafolls Sandoz Industrial Products, S.A.
India
Navi Mumbai Sandoz Private Limited





12. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Doxercalciferol. 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
4MCG/2ML (2MCG/ML)

injectable Discontinued INJECTION N/A Nov 14, 2019
2MCG/ML (2MCG/ML)

injectable Discontinued INJECTION N/A Nov 14, 2019


Manufacturing Plant Locations
New

Sun Pharm'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 Sun Pharm as present at those locations.

Country City Firm Name
United States
Lexington Sun Pharmaceutical Industries Inc
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Billerica Sun Pharmaceutical Industries, Inc.
India
Punjab Sun Pharmaceutical Industries, Inc.
New Delhi Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd.
Mohali Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Dadra Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Ahmednagar Sun Pharmaceutical Industries Limited
Bharuch Sun Pharmaceutical Industries Ltd
Vadodara Sun Pharmaceutical Industries Ltd
Halol Sun Pharmaceutical Industries Ltd.
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Baruch Sun Pharmaceutical Industries Ltd.
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)