TRANDATE Drug Patent Profile
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When do Trandate patents expire, and what generic alternatives are available?
Trandate is a drug marketed by Sebela Ireland Ltd, Alvogen, and Glaxosmithkline. and is included in three NDAs.
The generic ingredient in TRANDATE is hydrochlorothiazide; labetalol hydrochloride. There are two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; labetalol hydrochloride profile page.
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Questions you can ask:
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Summary for TRANDATE
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 10 |
| Patent Applications: | 1,193 |
| What excipients (inactive ingredients) are in TRANDATE? | TRANDATE excipients list |
| DailyMed Link: | TRANDATE at DailyMed |
Recent Clinical Trials for TRANDATE
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sebela Ireland Ltd | TRANDATE | labetalol hydrochloride | INJECTABLE;INJECTION | 019425-001 | Dec 31, 1985 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-002 | Apr 10, 1987 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-003 | Aug 1, 1984 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-003 | Apr 10, 1987 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-001 | May 24, 1985 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 TRANDATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sebela Ireland Ltd | TRANDATE | labetalol hydrochloride | INJECTABLE;INJECTION | 019425-001 | Dec 31, 1985 | 4,012,444 | ⤷ Start Trial |
| Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-003 | Aug 1, 1984 | 4,066,755 | ⤷ Start Trial |
| Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-004 | Aug 1, 1984 | 4,012,444 | ⤷ Start Trial |
| Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-003 | Aug 1, 1984 | 4,012,444 | ⤷ Start Trial |
| Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-001 | May 24, 1985 | 4,066,755 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TRANDATE
See the table below for patents covering TRANDATE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 280996 | ⤷ Start Trial | |
| Austria | 300763 | ⤷ Start Trial | |
| Belgium | 704037 | ⤷ Start Trial | |
| Belgium | 752892 | ⤷ Start Trial | |
| Canada | 932734 | PHENYLAMINOETHANOL DERIVATIVES | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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