NEBIVOLOL HYDROCHLORIDE Drug Patent Profile
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When do Nebivolol Hydrochloride patents expire, and when can generic versions of Nebivolol Hydrochloride launch?
Nebivolol Hydrochloride is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Beximco Pharms Usa, Cadila Pharms Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Indchemie Health, Mankind Pharma, Prinston Inc, Reyoung, Torrent, Unichem, and Watson Labs Inc. and is included in sixteen NDAs.
The generic ingredient in NEBIVOLOL HYDROCHLORIDE is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nebivolol Hydrochloride
A generic version of NEBIVOLOL HYDROCHLORIDE was approved as nebivolol hydrochloride by ANI PHARMS on April 16th, 2015.
Summary for NEBIVOLOL HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 16 |
| NDAs: | 16 |
| Finished Product Suppliers / Packagers: | 18 |
| Raw Ingredient (Bulk) Api Vendors: | 158 |
| Clinical Trials: | 94 |
| Patent Applications: | 79 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NEBIVOLOL HYDROCHLORIDE |
| DailyMed Link: | NEBIVOLOL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for NEBIVOLOL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Clinical Hospital Center Zemun | Phase 4 |
| Daewoong Pharmaceutical Co. LTD. | Phase 1 |
| Menarini International Operations Luxembourg SA | Phase 4 |
Pharmacology for NEBIVOLOL HYDROCHLORIDE
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for NEBIVOLOL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for NEBIVOLOL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for NEBIVOLOL HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BYSTOLIC | Tablets | nebivolol hydrochloride | 2.5 mg, 5 mg, 10 mg, and 20 mg | 021742 | 7 | 2011-12-19 |
US Patents and Regulatory Information for NEBIVOLOL HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mankind Pharma | NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 216172-003 | Nov 14, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hetero Labs Ltd Iii | NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 203825-002 | Nov 3, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Reyoung | NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 212917-003 | Dec 17, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Watson Labs Inc | NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 203683-002 | Nov 27, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Prinston Inc | NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 212682-003 | Apr 7, 2022 | AB | RX | No | No | ⤷ 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 |
