NORMODYNE Drug Patent Profile
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Which patents cover Normodyne, and what generic alternatives are available?
Normodyne is a drug marketed by Schering and is included in two NDAs.
The generic ingredient in NORMODYNE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Normodyne
A generic version of NORMODYNE was approved as labetalol hydrochloride by HERITAGE PHARMA on August 3rd, 1998.
Summary for NORMODYNE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 74 |
Clinical Trials: | 2 |
Patent Applications: | 4,301 |
Formulation / Manufacturing: | see details |
DailyMed Link: | NORMODYNE at DailyMed |
Recent Clinical Trials for NORMODYNE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Nebraska Methodist Health System | Phase 4 |
Lyndon B Johnson General Hospital | Phase 4 |
Northwestern | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for NORMODYNE
US Patents and Regulatory Information for NORMODYNE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Schering | NORMODYNE | labetalol hydrochloride | INJECTABLE;INJECTION | 018686-001 | Aug 1, 1984 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-003 | Aug 1, 1984 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-001 | Aug 31, 1987 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-002 | Aug 1, 1984 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-004 | Aug 1, 1984 | DISCN | Yes | No | ⤷ 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 NORMODYNE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-003 | Aug 1, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-002 | Aug 1, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
Schering | NORMODYNE | labetalol hydrochloride | INJECTABLE;INJECTION | 018686-001 | Aug 1, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-001 | Aug 31, 1987 | ⤷ Try a Trial | ⤷ Try a Trial |
Schering | NORMODYNE | labetalol hydrochloride | INJECTABLE;INJECTION | 018686-001 | Aug 1, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NORMODYNE
See the table below for patents covering NORMODYNE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
France | 8010 | ⤷ Try a Trial | |
Denmark | 133279 | ⤷ Try a Trial | |
Switzerland | 592051 | ⤷ Try a Trial | |
Israel | 28643 | 1-PHENYL-2-AMINOETHANOL DERIVATIVES | ⤷ Try a Trial |
Greece | 34663 | ΜΕΘΟΔΟΣ ΔΙΑ ΤΗΝ ΠΑΡΑΣΚΕΥΗΝ ΠΑΡΑΓΩΓΩΝ ΦΕΝΥΛΑΜΙΝΟΕΘΑΝΟΛΗΣ. | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |