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Calcitriol Patent Expiration

Calcitriol was first introduced by Esjay Pharma Llc in its drug Rocaltrol on Approved Prior to Jan 1, 1982. Other drugs containing Calcitriol are Vectical, Calcijex. 20 different companies have introduced drugs containing Calcitriol.


Calcitriol Patents

Given below is the list of patents protecting Calcitriol, 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
Calcijex US6051567

(Pediatric)

 Low oxygen content compositions of 1α, 25-dihydroxycholecalciferol Feb 02, 2020

(Expired)

 Abbvie
Calcijex US6265392

(Pediatric)

 Low oxygen content compositions of 1α, 25-dihydroxycholeclciferol Feb 02, 2020

(Expired)

 Abbvie
Calcijex US6274169

(Pediatric)

 Low oxygen content compostions of 1α, 25-dihydroxycholecalciferol Feb 02, 2020

(Expired)

 Abbvie
Calcijex US6051567 Low oxygen content compositions of 1α, 25-dihydroxycholecalciferol Aug 02, 2019

(Expired)

 Abbvie
Calcijex US6265392 Low oxygen content compositions of 1α, 25-dihydroxycholeclciferol Aug 02, 2019

(Expired)

 Abbvie
Calcijex US6274169 Low oxygen content compostions of 1α, 25-dihydroxycholecalciferol Aug 02, 2019

(Expired)

 Abbvie



Calcitriol's Family Patents

Family Patents

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Calcitriol Generic API Manufacturers

Several generic applications have been filed for Calcitriol. The first generic version for Calcitriol was by Teva Pharmaceuticals Usa Inc and was approved on Oct 12, 2001. And the latest generic version is by Anda Repository Llc and was approved on Jul 28, 2023.

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


1. AM REGENT

American Regent Inc has filed for 2 different strengths of generic version for Calcitriol. Given below are the details of the strengths of this generic introduced by Am Regent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.001MG/ML

injectable Discontinued INJECTION N/A Sep 26, 2003
0.002MG/ML

injectable Discontinued INJECTION N/A Sep 26, 2003





2. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 2 different strengths of generic version for Calcitriol. 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
0.5MCG

capsule Prescription ORAL AB Jun 14, 2017
0.25MCG

capsule Prescription ORAL AB Jun 14, 2017





3. ANDA REPOSITORY

Anda Repository Llc has filed for 1 generic for Calcitriol. Given below are the details of the strengths of this generic introduced by Anda Repository.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MCG/ML

solution Prescription ORAL AA Jul 28, 2023





4. BIONPHARMA

Bionpharma Inc has filed for 2 different strengths of generic version for Calcitriol. Given below are the details of the strengths of this generic introduced by Bionpharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25MCG

capsule Prescription ORAL AB May 24, 2013
0.5MCG

capsule Prescription ORAL AB May 24, 2013


Manufacturing Plant Locations
New

Bionpharma'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 Bionpharma as present at those locations.

Country City Firm Name
United States
Princeton Bionpharma Inc.





5. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 2 different strengths of generic version for Calcitriol. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.002MG/ML

injectable Discontinued INJECTION N/A Dec 31, 2002
0.001MG/ML

injectable Discontinued INJECTION N/A Dec 31, 2002


Manufacturing Plant Locations
New

Fresenius Kabi Usa'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 Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
North Andover Fresenius Kabi USA, LLC
Skokie Fresenius Kabi USA LLC
Wilson Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA LLC
Melrose Park Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
Lake Zurich Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC





6. FRESENIUS MEDCL

Fresenius Medical Care North America has filed for 2 different strengths of generic version for Calcitriol. Given below are the details of the strengths of this generic introduced by Fresenius Medcl.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.001MG/ML

injectable Discontinued INJECTION N/A Feb 20, 2003
0.002MG/ML

injectable Discontinued INJECTION N/A Feb 20, 2003





7. GLAND

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.001MG/ML

injectable Prescription INJECTION AP Feb 3, 2020


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





8. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Calcitriol. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MCG/ML

solution Prescription ORAL AA Jul 18, 2003
0.25MCG

capsule Prescription ORAL AB Mar 27, 2006


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





9. HOSPIRA

Hospira Inc has filed for 2 different strengths of generic version for Calcitriol. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.002MG/ML

injectable Discontinued INJECTION N/A Jan 16, 2004
0.001MG/ML

injectable Discontinued INJECTION N/A Jan 16, 2004


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Lake Forest Hospira Inc
Rocky Mount Hospira, Inc.
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Morgan Hill Hospira Inc
Mcpherson Hospira, Inc., A Pfizer Company
Clayton Hospira, Inc.
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





10. LONG GROVE PHARMS

Long Grove Pharmaceuticals Llc has filed for 2 different strengths of generic version for Calcitriol. Given below are the details of the strengths of this generic introduced by Long Grove Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.002MG/ML

injectable Discontinued INJECTION N/A Jan 29, 2008
0.001MG/ML

(reference standard)

injectable Prescription INJECTION AP Jan 29, 2008





11. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Calcitriol. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MCG/ML

solution Prescription ORAL AA Nov 21, 2018


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





12. ROCKWELL MEDCL

Rockwell Medical Technologies Inc has filed for 1 generic for Calcitriol. Given below are the details of the strengths of this generic introduced by Rockwell Medcl.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.001MG/ML

injectable Discontinued INJECTION N/A Sep 17, 2003





13. SAGENT PHARMS

Sagent Pharmaceuticals Inc has filed for 1 generic for Calcitriol. Given below are the details of the strengths of this generic introduced by Sagent Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.001MG/ML

injectable Discontinued INJECTION N/A Feb 8, 2006





14. STRIDES SOFTGELS

Strides Softgels Pte Ltd has filed for 2 different strengths of generic version for Calcitriol. Given below are the details of the strengths of this generic introduced by Strides Softgels.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25MCG

capsule Prescription ORAL AB Dec 12, 2014
0.5MCG

(reference standard)

capsule Prescription ORAL AB Dec 12, 2014





15. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Calcitriol. 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
0.25MCG

capsule Discontinued ORAL N/A Feb 21, 2019
0.5MCG

capsule Discontinued ORAL N/A Feb 21, 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
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Billerica Sun Pharmaceutical Industries, Inc.
Lexington Sun Pharmaceutical Industries Inc
India
Punjab Sun Pharmaceutical Industries, Inc.
Dadra Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Baruch Sun Pharmaceutical Industries Ltd.
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Vadodara Sun Pharmaceutical Industries Ltd
Vadodara Sun Pharmaceutical Industries Ltd.
Ahmednagar Sun Pharmaceutical Industries Limited
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
New Delhi Sun Pharmaceutical Industries Limited
Halol Sun Pharmaceutical Industries Ltd.
Mohali Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Bharuch Sun Pharmaceutical Industries Ltd





16. TEVA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Calcitriol. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25MCG

capsule Prescription ORAL AB Oct 12, 2001
0.5MCG

capsule Prescription ORAL AB Oct 12, 2001


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Miami Teva Branded Pharmaceutical Products R & D, Inc.
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Fort Dodge TEVA Animal Health Inc
Horsham Teva Branded Pharmaceutical Products R&D
India
Bhind Teva API India Ltd- Malanpur
Gajraula, Amroha Teva API India Private Ltd.
Canada
Markham Teva Canada Limited
Scarborough Teva Canada Limited
Stouffville Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





17. TEVA PARENTERAL

Teva Parenteral Medicines Inc has filed for 2 different strengths of generic version for Calcitriol. Given below are the details of the strengths of this generic introduced by Teva Parenteral.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.002MG/ML

injectable Discontinued INJECTION N/A Mar 31, 2003
0.001MG/ML

injectable Discontinued INJECTION N/A Mar 31, 2003


Manufacturing Plant Locations
New

Teva Parenteral'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 Teva Parenteral as present at those locations.

Country City Firm Name
United States
Irvine Teva Parenteral Medicines, Inc.