Calcijex is a drug owned by Abbvie Inc. It is protected by 6 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 02, 2020. Details of Calcijex's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6051567 (Pediatric) | Low oxygen content compositions of 1α, 25-dihydroxycholecalciferol |
Feb, 2020
(6 years ago) |
Expired
|
|
US6274169 (Pediatric) | Low oxygen content compostions of 1α, 25-dihydroxycholecalciferol |
Feb, 2020
(6 years ago) |
Expired
|
|
US6265392 (Pediatric) | Low oxygen content compositions of 1α, 25-dihydroxycholeclciferol |
Feb, 2020
(6 years ago) |
Expired
|
| US6051567 | Low oxygen content compositions of 1α, 25-dihydroxycholecalciferol |
Aug, 2019
(7 years ago) |
Expired
|
| US6274169 | Low oxygen content compostions of 1α, 25-dihydroxycholecalciferol |
Aug, 2019
(7 years ago) |
Expired
|
| US6265392 | Low oxygen content compositions of 1α, 25-dihydroxycholeclciferol |
Aug, 2019
(7 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but
Calcijex is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Calcijex's family patents as well as insights into
ongoing legal events
on those patents.
Calcijex's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Calcijex:
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 |
|---|---|---|---|---|
 | ||||
| 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 |
Generic Launch
Generic Release Date:
Calcijex's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 02, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Calcijex Generic API suppliers:
Calcitriol is the generic name for the brand Calcijex. 18 different companies have already filed for the generic of Calcijex, with Teva Parenteral having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Calcijex's generic
How can I launch a generic of Calcijex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Calcijex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Calcijex's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Calcijex -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| None |
About Calcijex
Calcijex is a drug owned by Abbvie Inc. Calcijex uses Calcitriol as an active ingredient. Calcijex was launched by Abbvie in 1986.
Approval Date:
Calcijex was approved by FDA for market use on 25 September, 1986.
Active Ingredient:
Calcijex uses Calcitriol as the active ingredient. Check out other Drugs and Companies using Calcitriol ingredient
Dosage:
Calcijex is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |
| 0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |