ACEBUTOLOL HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for acebutolol hydrochloride and what is the scope of patent protection?
Acebutolol hydrochloride
is the generic ingredient in two branded drugs marketed by Amneal Pharm, Ani Pharms, Norvium Bioscience, and Promius Pharma, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for acebutolol hydrochloride. Six suppliers are listed for this compound.
Summary for ACEBUTOLOL HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: | 7 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 7 |
| Patent Applications: | 2,872 |
| What excipients (inactive ingredients) are in ACEBUTOLOL HYDROCHLORIDE? | ACEBUTOLOL HYDROCHLORIDE excipients list |
| DailyMed Link: | ACEBUTOLOL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for ACEBUTOLOL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Weill Medical College of Cornell University | Phase 4 |
| National Institute on Aging (NIA) | Phase 4 |
| The New York Community Trust | Phase 4 |
Pharmacology for ACEBUTOLOL HYDROCHLORIDE
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for ACEBUTOLOL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for ACEBUTOLOL HYDROCHLORIDE
US Patents and Regulatory Information for ACEBUTOLOL HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | ACEBUTOLOL HYDROCHLORIDE | acebutolol hydrochloride | CAPSULE;ORAL | 074007-002 | Oct 18, 1995 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Norvium Bioscience | ACEBUTOLOL HYDROCHLORIDE | acebutolol hydrochloride | CAPSULE;ORAL | 074288-002 | Apr 24, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal Pharm | ACEBUTOLOL HYDROCHLORIDE | acebutolol hydrochloride | CAPSULE;ORAL | 075047-002 | Dec 30, 1999 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ani Pharms | ACEBUTOLOL HYDROCHLORIDE | acebutolol hydrochloride | CAPSULE;ORAL | 074007-001 | Oct 18, 1995 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal Pharm | ACEBUTOLOL HYDROCHLORIDE | acebutolol hydrochloride | CAPSULE;ORAL | 075047-001 | Dec 30, 1999 | AB | RX | No | Yes | ⤷ 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 ACEBUTOLOL HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Promius Pharma | SECTRAL | acebutolol hydrochloride | CAPSULE;ORAL | 018917-001 | Dec 28, 1984 | ⤷ Sign Up | ⤷ Sign Up |
| Promius Pharma | SECTRAL | acebutolol hydrochloride | CAPSULE;ORAL | 018917-003 | Dec 28, 1984 | ⤷ Sign Up | ⤷ Sign Up |
| Promius Pharma | SECTRAL | acebutolol hydrochloride | CAPSULE;ORAL | 018917-003 | Dec 28, 1984 | ⤷ Sign Up | ⤷ Sign Up |
| Promius Pharma | SECTRAL | acebutolol hydrochloride | CAPSULE;ORAL | 018917-001 | Dec 28, 1984 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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. 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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