Nebivolol hydrochloride - Generic Drug Details
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What are the generic drug sources for nebivolol hydrochloride and what is the scope of freedom to operate?
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, MSN, Prinston Inc, Reyoung, Torrent, Unichem, Watson Labs Inc, and Abbvie, and is included in twenty 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. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for nebivolol hydrochloride
US Patents: | 2 |
Tradenames: | 4 |
Applicants: | 19 |
NDAs: | 20 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 23 |
Raw Ingredient (Bulk) Api Vendors: | 158 |
Clinical Trials: | 95 |
Patent Applications: | 137 |
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 |
⤷ Sign Up | ⤷ Sign Up | 20MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 10MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 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
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
Expired US Patents for nebivolol hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-005 | Oct 8, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-002 | Dec 17, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-003 | Dec 17, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-004 | Dec 17, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-003 | Dec 17, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-005 | Oct 8, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-002 | Dec 17, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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