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 thirty-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:
- What is the 5 year forecast for TRANDATE?
- What are the global sales for TRANDATE?
- What is Average Wholesale Price for TRANDATE?
Summary for TRANDATE
US Patents: | 0 |
Applicants: | 3 |
NDAs: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 74 |
Clinical Trials: | 10 |
Patent Applications: | 804 |
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 | ⤷ 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 | ||||
Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-003 | Aug 1, 1984 | DISCN | Yes | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-001 | May 24, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Sebela Ireland Ltd | TRANDATE | labetalol hydrochloride | INJECTABLE;INJECTION | 019425-001 | Dec 31, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-003 | Aug 1, 1984 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Cyprus | 806 | PHENYLAMINOETHANOL DERIVATIVES | ⤷ Sign Up |
Greece | 34663 | ΜΕΘΟΔΟΣ ΔΙΑ ΤΗΝ ΠΑΡΑΣΚΕΥΗΝ ΠΑΡΑΓΩΓΩΝ ΦΕΝΥΛΑΜΙΝΟΕΘΑΝΟΛΗΣ. | ⤷ Sign Up |
Kenya | 2539 | PHENYLAMINOETHANOL DERIVATIVES | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |