TARGRETIN Drug Patent Profile
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When do Targretin patents expire, and what generic alternatives are available?
Targretin is a drug marketed by Valeant Luxembourg and Bausch and is included in two NDAs.
The generic ingredient in TARGRETIN is bexarotene. There are seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the bexarotene profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Targretin
A generic version of TARGRETIN was approved as bexarotene by BIONPHARMA on August 12th, 2014.
Summary for TARGRETIN
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 130 |
| Clinical Trials: | 30 |
| Patent Applications: | 4,256 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TARGRETIN |
| What excipients (inactive ingredients) are in TARGRETIN? | TARGRETIN excipients list |
| DailyMed Link: | TARGRETIN at DailyMed |
Recent Clinical Trials for TARGRETIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Medical Research Council (NMRC), Singapore | Phase 1 |
| National Cancer Centre, Singapore | Phase 1 |
| The Cleveland Clinic | Phase 2 |
Pharmacology for TARGRETIN
| Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for TARGRETIN
US Patents and Regulatory Information for TARGRETIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Valeant Luxembourg | TARGRETIN | bexarotene | CAPSULE;ORAL | 021055-001 | Dec 29, 1999 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Bausch | TARGRETIN | bexarotene | GEL;TOPICAL | 021056-001 | Jun 28, 2000 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 TARGRETIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Valeant Luxembourg | TARGRETIN | bexarotene | CAPSULE;ORAL | 021055-001 | Dec 29, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Valeant Luxembourg | TARGRETIN | bexarotene | CAPSULE;ORAL | 021055-001 | Dec 29, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Valeant Luxembourg | TARGRETIN | bexarotene | CAPSULE;ORAL | 021055-001 | Dec 29, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Valeant Luxembourg | TARGRETIN | bexarotene | CAPSULE;ORAL | 021055-001 | Dec 29, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for TARGRETIN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Eisai GmbH | Targretin | bexarotene | EMEA/H/C/000326 Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment. |
Authorised | no | no | no | 2001-03-29 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for TARGRETIN
See the table below for patents covering TARGRETIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Greece | 3030104 | ⤷ Try a Trial | |
| Japan | 3727334 | ⤷ Try a Trial | |
| Spain | 2149814 | ⤷ Try a Trial | |
| Australia | 5586894 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TARGRETIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0637297 | SPC013/2001 | Ireland | ⤷ Try a Trial | SPC013/2001: 20031205, EXPIRES: 20160328 |
| 0637297 | C300054 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: BEXAROTENE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVER- BINDING MET DE FORMULE R9OH, WAARIN R9 EEN; NAT. REGISTRATION NO/DATE: EU/1/01/178/001 20010329; FIRST REGISTRATION: EU/1/01/178/001 20010329 |
| 0637297 | SPC/GB01/041 | United Kingdom | ⤷ Try a Trial | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB01/041 GRANTED TO EISAI R + D MANAGEMENT., LTD. IN RESPECT OF THE PRODUCT BEXAROTENE (4-(1-(3, 5, 5, 8, 8-PENTAMETHYL-5, 6, 7, 8-TETRAHYDRO-2-NAPHTHALENYL)VINYL)BENZOIC ACID), WHICH WAS ADVERTISED AS COMING INTO FORCE IN JOURNAL NO 6469 DATED 15/05/2013 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, IT WILL EXPIRE ON 01/04/2016. |
| 0637297 | 01C0027 | France | ⤷ Try a Trial | PRODUCT NAME: BEXAROTENE; REGISTRATION NO/DATE: EU/1/01/178/001 20010329 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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