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Last Updated: March 29, 2024

Acebutolol hydrochloride - Generic Drug Details


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What are the generic 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, Mylan, 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
Recent Clinical Trials for acebutolol hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute on Aging (NIA)Phase 4
The New York Community TrustPhase 4
Weill Medical College of Cornell UniversityPhase 4

See all acebutolol hydrochloride clinical trials

Pharmacology for acebutolol hydrochloride
Medical Subject Heading (MeSH) Categories 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
Amneal Pharm ACEBUTOLOL HYDROCHLORIDE acebutolol hydrochloride CAPSULE;ORAL 075047-001 Dec 30, 1999 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Promius Pharma SECTRAL acebutolol hydrochloride CAPSULE;ORAL 018917-003 Dec 28, 1984 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan ACEBUTOLOL HYDROCHLORIDE acebutolol hydrochloride CAPSULE;ORAL 074288-002 Apr 24, 1995 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms ACEBUTOLOL HYDROCHLORIDE acebutolol hydrochloride CAPSULE;ORAL 074007-002 Oct 18, 1995 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharm ACEBUTOLOL HYDROCHLORIDE acebutolol hydrochloride CAPSULE;ORAL 075047-002 Dec 30, 1999 AB RX No Yes ⤷  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 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 ⤷  Try a Trial ⤷  Try a Trial
Promius Pharma SECTRAL acebutolol hydrochloride CAPSULE;ORAL 018917-001 Dec 28, 1984 ⤷  Try a Trial ⤷  Try a Trial
Promius Pharma SECTRAL acebutolol hydrochloride CAPSULE;ORAL 018917-003 Dec 28, 1984 ⤷  Try a Trial ⤷  Try a Trial
Promius Pharma SECTRAL acebutolol hydrochloride CAPSULE;ORAL 018917-003 Dec 28, 1984 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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