NEBIVOLOL HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for nebivolol hydrochloride and what is the scope of patent protection?
Nebivolol hydrochloride
is the generic ingredient in four branded drugs marketed by Allergan, 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, Watson Labs Inc, and Abbvie, and is included in nineteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are thirteen drug master file entries for nebivolol hydrochloride. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for NEBIVOLOL HYDROCHLORIDE
| US Patents: | 2 |
| Tradenames: | 4 |
| Applicants: | 18 |
| NDAs: | 19 |
| Drug Master File Entries: | 13 |
| Finished Product Suppliers / Packagers: | 19 |
| Raw Ingredient (Bulk) Api Vendors: | 158 |
| Clinical Trials: | 94 |
| Patent Applications: | 139 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NEBIVOLOL HYDROCHLORIDE |
| What excipients (inactive ingredients) are in NEBIVOLOL HYDROCHLORIDE? | NEBIVOLOL HYDROCHLORIDE excipients list |
| 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 |
Generic filers with tentative approvals for NEBIVOLOL HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 20MG | TABLET;ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 10MG | TABLET;ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 5MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for NEBIVOLOL HYDROCHLORIDE
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories 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
Expired US Patents for NEBIVOLOL HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-003 | Dec 17, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-003 | Dec 17, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-004 | Dec 17, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-002 | Dec 17, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-004 | Dec 17, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-005 | Oct 8, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-005 | Oct 8, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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