ROCALTROL Drug Patent Profile

When do Rocaltrol patents expire, and when can generic versions of Rocaltrol launch?

Rocaltrol is a drug marketed by Ss Pharma and is included in two NDAs.

The generic ingredient in ROCALTROL is calcitriol. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcitriol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rocaltrol

A generic version of ROCALTROL was approved as calcitriol by TEVA on October 12^th, 2001.

Summary for ROCALTROL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	27
Patent Applications:	4,220
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ROCALTROL
What excipients (inactive ingredients) are in ROCALTROL?	ROCALTROL excipients list
DailyMed Link:	ROCALTROL at DailyMed

See drug prices for ROCALTROL

See drug sales revenues for ROCALTROL

Recent Clinical Trials for ROCALTROL

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

Sponsor	Phase
RenJi Hospital	N/A
Institut de Recerca Biomèdica de Lleida	Phase 4
Berta Alemany	Phase 4

See all ROCALTROL clinical trials

Pharmacology for ROCALTROL

Drug Class

Vitamin D3 Analog

Anatomical Therapeutic Chemical (ATC) Classes for ROCALTROL

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 ROCALTROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Ss Pharma	ROCALTROL	calcitriol	SOLUTION;ORAL	021068-001	Nov 20, 1998	AA	RX	Yes	Yes

Expired US Patents for ROCALTROL

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
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982

International Patents for ROCALTROL

See the table below for patents covering ROCALTROL around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H0115484
Japan	S57149224	TUMOR-SUPPRESSING AGENT
Canada	962666	1,25-DIHYDROXYCHOLECALIFEROL
Japan	S5626820	IMMUNOSUPPRESSING AGENT