NORMODYNE Drug Patent Profile
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Which patents cover Normodyne, and when can generic versions of Normodyne launch?
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.
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Summary for NORMODYNE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 2 |
| Patent Applications: | 4,247 |
| 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 |
| TriHealth Inc. | Phase 4 |
| University of Kansas Medical Center | Phase 4 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-003 | Aug 1, 1984 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-001 | Aug 31, 1987 | 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 NORMODYNE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Schering | NORMODYNE | labetalol hydrochloride | INJECTABLE;INJECTION | 018686-001 | Aug 1, 1984 | ⤷ Sign Up | ⤷ Sign Up |
| Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-001 | Aug 31, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-001 | Aug 31, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NORMODYNE
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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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