ACEBUTOLOL HYDROCHLORIDE Drug Patent Profile
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When do Acebutolol Hydrochloride patents expire, and what generic alternatives are available?
Acebutolol Hydrochloride is a drug marketed by Amneal Pharm, Ani Pharms, and Mylan. and is included in three NDAs.
The generic ingredient in ACEBUTOLOL HYDROCHLORIDE is acebutolol hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acebutolol hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Acebutolol Hydrochloride
A generic version of ACEBUTOLOL HYDROCHLORIDE was approved as acebutolol hydrochloride by ANI PHARMS on October 18th, 1995.
Summary for ACEBUTOLOL HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 7 |
| Patent Applications: | 2,030 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | ACEBUTOLOL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for ACEBUTOLOL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute on Aging (NIA) | Phase 4 |
| The New York Community Trust | Phase 4 |
| Weill Medical College of Cornell University | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| 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 |
