Calcifediol - Generic Drug Details

What are the generic drug 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 forty-nine patent family members in thirty-four countries.

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

Summary for calcifediol

International Patents:	149
US Patents:	15
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	23
Patent Applications:	6,310
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

Anatomical Therapeutic Chemical (ATC) Classes for calcifediol

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

H05BX	Other anti-parathyroid agents
H05B	ANTI-PARATHYROID AGENTS
H05	CALCIUM HOMEOSTASIS
H	Systemic hormonal preparations, excluding sex hormones and insulins

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
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
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
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes			Y

Expired US Patents for calcifediol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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

International Patents for calcifediol

Country	Patent Number	Title	Estimated Expiration
Spain	2496915
Portugal	2968172
South Korea	20140113374	STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING SAME
South Korea	20190028822	비타민 Ｄ 화합물과 밀랍성 담체를 포함하는 경구 조절성 방출 조성물 (ORAL CONTROLLED RELEASE COMPOSITIONS COMPRISING VITAMIN D COMPOUND AND WAXY CARRIER)
South Korea	20210078463	안정화되고 변형된 비타민 Ｄ 방출 제형 및 이의 투여 방법 (STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING SAME)
Australia	2014228069	Stabilized modified release vitamin D formulation and method of administring same

Supplementary Protection Certificates for calcifediol

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	132021000000074	Italy		PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
2481400	301085	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
2968172	CA 2021 00005	Denmark		PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: DE 2202115.00.00 20200818
2481400	CA 2020 00059	Denmark		PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: UK PL 50784/0005-0001 20200721