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-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 12th, 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 |
Recent Clinical Trials for ROCALTROL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| RenJi Hospital | N/A |
| Universitat de Lleida | Phase 4 |
| Institut de Recerca Biomèdica de Lleida | Phase 4 |
Pharmacology for ROCALTROL
| Drug Class | Vitamin D3 Analog |
Anatomical Therapeutic Chemical (ATC) Classes for ROCALTROL
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 | ⤷ 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ss Pharma | ROCALTROL | calcitriol | CAPSULE;ORAL | 018044-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Ss Pharma | ROCALTROL | calcitriol | CAPSULE;ORAL | 018044-001 | 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 | 018044-001 | 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 |
| >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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | S57149224 | TUMOR-SUPPRESSING AGENT | ⤷ Sign Up |
| Japan | S5626820 | IMMUNOSUPPRESSING AGENT | ⤷ Sign Up |
| Japan | S6365646 | ⤷ Sign Up | |
| Netherlands | 7202496 | ⤷ Sign Up | |
| Canada | 962666 | 1,25-DIHYDROXYCHOLECALIFEROL | ⤷ Sign Up |
| United Kingdom | 1331011 | ⤷ Sign Up | |
| Japan | S5544727 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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