Calcifediol - Generic Drug Details

What are the generic sources for calcifediol and what is the scope of patent protection?

Calcifediol is the generic ingredient in two branded drugs marketed by Eirgen and Organon Usa Inc, and is included in two NDAs. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Calcifediol has one hundred and fifty patent family members in thirty-five countries.

There are two drug master file entries for calcifediol. One supplier is listed for this compound.

Summary for calcifediol

International Patents:	150
US Patents:	15
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	23
Patent Applications:	6,455
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in calcifediol?	calcifediol excipients list
DailyMed Link:	calcifediol at DailyMed

Recent Clinical Trials for calcifediol

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

Sponsor	Phase
Shanghai Jiao Tong University School of Medicine	Phase 3
Indonesia University	Phase 2
Faes Farma, S.A.	Phase 2/Phase 3

See all calcifediol clinical trials

Pharmacology for calcifediol

Drug Class

Vitamin D3 Analog

Medical Subject Heading (MeSH) Categories for calcifediol

Bone Density Conservation Agents

Vitamins

US Patents and Regulatory Information for calcifediol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes			Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes			Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes

Expired US Patents for calcifediol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982

International Patents for calcifediol

Country	Patent Number	Title	Estimated Expiration
Spain	2904546
Eurasian Patent Organization	038867	СТАБИЛИЗИРОВАННЫЙ СОСТАВ ВИТАМИНА D С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ (STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION)
South Korea	20140113374	STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING SAME
Poland	3095447

Supplementary Protection Certificates for calcifediol

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2481400	CA 2020 00059	Denmark		PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: UK PL 50784/0005-0001 20200721
2968172	122021000009	Germany		PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; REGISTRATION NO/DATE: 2202115.00.00 20200818
2481400	122020000079	Germany		PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; NAT. REGISTRATION NO/DATE: 2202115.00.00 20200818; FIRST REGISTRATION: VEREINIGTES KOENIGREICH GROSSBRITANNIEN UND NORDIRLAND PL 50784/0005 - 0001 20200721
2968172	301095	Netherlands		PRODUCT NAME: CALCIFEDIOL IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; NATIONAL REGISTRATION NO/DATE: 124799 20200922; FIRST REGISTRATION: DE 2202115.00.00 20200819