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Last Updated: April 16, 2024

Calcitriol - Generic Drug Details

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What are the generic 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, Patrin, 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-three 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:	23
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	172
Patent Applications:	6,144
Formulation / Manufacturing:	see details
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

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

US Patents and Regulatory Information for calcitriol

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Glossary

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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
Fresenius Kabi Usa	CALCITRIOL	calcitriol	INJECTABLE;INJECTION	075836-002	Dec 31, 2002		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Long Grove Pharms	CALCITRIOL	calcitriol	INJECTABLE;INJECTION	078066-002	Jan 29, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Abbvie	CALCIJEX	calcitriol	INJECTABLE;INJECTION	018874-002	Sep 25, 1986	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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