TRANDATE HCT Drug Patent Profile
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When do Trandate Hct patents expire, and when can generic versions of Trandate Hct launch?
Trandate Hct is a drug marketed by Glaxosmithkline and is included in one NDA.
The generic ingredient in TRANDATE HCT is hydrochlorothiazide; labetalol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; labetalol hydrochloride profile page.
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Summary for TRANDATE HCT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 10 |
| DailyMed Link: | TRANDATE HCT at DailyMed |
Recent Clinical Trials for TRANDATE HCT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Loma Linda University | N/A |
| Nebraska Methodist Health System | Phase 4 |
| Wright State University | Phase 4 |
US Patents and Regulatory Information for TRANDATE HCT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-001 | Apr 10, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-004 | Apr 10, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-002 | Apr 10, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-003 | Apr 10, 1987 | DISCN | No | No | ⤷ 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 TRANDATE HCT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-002 | Apr 10, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-001 | Apr 10, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-004 | Apr 10, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-002 | Apr 10, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TRANDATE HCT
See the table below for patents covering TRANDATE HCT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Cyprus | 806 | PHENYLAMINOETHANOL DERIVATIVES | ⤷ Sign Up |
| Greece | 34663 | ΜΕΘΟΔΟΣ ΔΙΑ ΤΗΝ ΠΑΡΑΣΚΕΥΗΝ ΠΑΡΑΓΩΓΩΝ ΦΕΝΥΛΑΜΙΝΟΕΘΑΝΟΛΗΣ. | ⤷ Sign Up |
| Kenya | 2539 | PHENYLAMINOETHANOL DERIVATIVES | ⤷ Sign Up |
| Netherlands | 160805 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TRANDATE HCT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0565634 | 06C0030 | France | ⤷ Sign Up | PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607 |
| 0502314 | SPC/GB02/037 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419 |
| 0454511 | 99C0009 | Belgium | ⤷ Sign Up | PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015 |
| 0480717 | 98C0025 | Belgium | ⤷ Sign Up | PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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