ROCALTROL Drug Patent Profile

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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-four 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.

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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
Drug Prices:	Drug price information for ROCALTROL
What excipients (inactive ingredients) are in ROCALTROL?	ROCALTROL excipients list
DailyMed Link:	ROCALTROL at DailyMed

Drug patent expirations by year 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

US Patents and Regulatory Information for ROCALTROL

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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
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	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
Ss Pharma	ROCALTROL	calcitriol	SOLUTION;ORAL	021068-001	Nov 20, 1998	AA	RX	Yes	Yes	⤷ 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 ROCALTROL

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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	⤷ 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
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

International Patents for ROCALTROL

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

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Country	Patent Number	Title	Estimated Expiration
Japan	H0115484		⤷ Sign Up
France	2126414		⤷ Sign Up
Japan	S5626820	IMMUNOSUPPRESSING AGENT	⤷ Sign Up
United Kingdom	1331011		⤷ Sign Up
Germany	2209352		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for ROCALTROL

Recent Clinical Trials for ROCALTROL

Pharmacology for ROCALTROL

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