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Last Updated: November 24, 2024

Calcitriol - Generic Drug Details

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What are the generic drug sources for calcitriol and what is the scope of freedom to operate?

Calcitriol is the generic ingredient in four branded drugs marketed by Amneal Pharms, Bionpharma, Hikma, Strides Pharma, Sun Pharm, Teva, Ss Pharma, Abbvie, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland Pharma Ltd, Hospira, Long Grove Pharms, Rockwell Medcl, Sagent Pharms, Teva Parenteral, Galderma Labs Lp, Anda Repository, and Rising, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for calcitriol. Twenty-four suppliers are listed for this compound.

Summary for calcitriol

US Patents:	0
Tradenames:	4
Applicants:	20
NDAs:	22
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	173
Patent Applications:	6,144
Drug Prices:	Drug price trends for calcitriol
Drug Sales Revenues:	Drug sales revenues for calcitriol
What excipients (inactive ingredients) are in calcitriol?	calcitriol excipients list
DailyMed Link:	calcitriol at DailyMed

Drug Prices for calcitriol

See drug prices for calcitriol

Drug Sales Revenue Trends for calcitriol

See drug sales revenues for calcitriol

Recent Clinical Trials for calcitriol

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Chugai Pharma China Co., Ltd.	Phase 4
Shanghai Jiao Tong University Affiliated Sixth People's Hospital	Phase 4
Xiaoyan Jia	Phase 4

See all calcitriol clinical trials

Pharmacology for calcitriol

Drug Class	Vitamin D3 Analog

Medical Subject Heading (MeSH) Categories for calcitriol

Bone Density Conservation Agents
Calcium Channel Agonists
Vitamins

Anatomical Therapeutic Chemical (ATC) Classes for calcitriol

A11CC	Vitamin D and analogues
A11C	VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO
A11	VITAMINS
A	Alimentary tract and metabolism

D05AX	Other antipsoriatics for topical use
D05A	ANTIPSORIATICS FOR TOPICAL USE
D05	ANTIPSORIATICS
D	Dermatologicals

US Patents and Regulatory Information for calcitriol

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	CALCITRIOL	calcitriol	SOLUTION;ORAL	076242-001	Jul 18, 2003	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	CALCITRIOL	calcitriol	INJECTABLE;INJECTION	075816-001	Jan 16, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-002	Sep 25, 1986		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	CALCITRIOL	calcitriol	INJECTABLE;INJECTION	075746-001	Sep 26, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	CALCITRIOL	calcitriol	CAPSULE;ORAL	203289-002	Jun 14, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for calcitriol

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-002	Sep 25, 1986	⤷ Sign Up	⤷ Sign Up
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-001	Sep 25, 1986	⤷ Sign Up	⤷ Sign Up
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-001	Sep 25, 1986	⤷ Sign Up	⤷ Sign Up
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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