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. 21 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.

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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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Clinical Trials

Recent Clinical Trials on Calcitriol:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
The GranStone Trial Martin Blomberg Jensen NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1 Calcilytix Therapeutics, Inc., a BridgeBio company NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Management of Iron Deficiency Anemia in Hemodialysis Patients Beni-Suef University NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis Sanofi NA TERMINATED
(Jun 1, 2026)
PHASE3
Vitamin D and Breast Cancer: Does Weight Make a Difference? Melinda Telli NA TERMINATED
(Apr 1, 2026)
PHASE2
Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia BPGbio NA COMPLETED
(Apr 1, 2026)
PHASE1


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 Humanwell Puracap Pharmaceutical Wuhan Co Ltd and was approved on Feb 27, 2026.

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