LABETALOL HYDROCHLORIDE Drug Patent Profile
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When do Labetalol Hydrochloride patents expire, and what generic alternatives are available?
Labetalol Hydrochloride is a drug marketed by Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience Speclts, Andas 5 Holding, Appco, Cadila Pharms Ltd, Endo Operations, Epic Pharma Llc, Heritage Pharma, Hibrow Hlthcare, Rubicon, Sandoz, Teva, Unichem, Watson Labs, and Zydus Pharms. and is included in twenty-six NDAs.
The generic ingredient in LABETALOL HYDROCHLORIDE 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 Labetalol Hydrochloride
A generic version of LABETALOL HYDROCHLORIDE was approved as labetalol hydrochloride by HERITAGE PHARMA on August 3rd, 1998.
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Questions you can ask:
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Summary for LABETALOL HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 21 |
| NDAs: | 26 |
| Finished Product Suppliers / Packagers: | 40 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 69 |
| Patent Applications: | 804 |
| What excipients (inactive ingredients) are in LABETALOL HYDROCHLORIDE? | LABETALOL HYDROCHLORIDE excipients list |
| DailyMed Link: | LABETALOL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for LABETALOL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Boston Medical Center | Phase 4 |
| Marshall University | Phase 2 |
| Loma Linda University | N/A |
Pharmacology for LABETALOL HYDROCHLORIDE
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for LABETALOL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for LABETALOL HYDROCHLORIDE
US Patents and Regulatory Information for LABETALOL HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 075113-001 | Aug 4, 1998 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Heritage Pharma | LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 074787-001 | Aug 3, 1998 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Unichem | LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 212719-003 | Aug 8, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 074989-002 | Sep 30, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | LABETALOL HYDROCHLORIDE | labetalol hydrochloride | TABLET;ORAL | 075133-001 | Aug 3, 1998 | AB | RX | No | 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 |
