NADOLOL - Generic Drug Details
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What are the generic drug sources for nadolol and what is the scope of freedom to operate?
Nadolol
is the generic ingredient in two branded drugs marketed by Uswm, Alembic, Amneal Pharms Co, Aurobindo Pharma, Beximco Pharms Usa, Chartwell Rx, Heritage Pharma, Invagen Pharms, Novast Labs, Rising, Rk Pharma, Sandoz, Teva Pharms, and Zydus Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for nadolol. Fifteen suppliers are listed for this compound.
Summary for NADOLOL
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 14 |
| NDAs: | 15 |
| Drug Master File Entries: | 5 |
| Finished Product Suppliers / Packagers: | 15 |
| Raw Ingredient (Bulk) Api Vendors: | 59 |
| Clinical Trials: | 23 |
| Patent Applications: | 6,813 |
| Drug Prices: | Drug price trends for NADOLOL |
| Drug Sales Revenues: | Drug sales revenues for NADOLOL |
| What excipients (inactive ingredients) are in NADOLOL? | NADOLOL excipients list |
| DailyMed Link: | NADOLOL at DailyMed |
Recent Clinical Trials for NADOLOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Unity Health Toronto | N/A |
| National Institute on Aging (NIA) | Phase 4 |
| The New York Community Trust | Phase 4 |
Pharmacology for NADOLOL
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for NADOLOL
Anatomical Therapeutic Chemical (ATC) Classes for NADOLOL
US Patents and Regulatory Information for NADOLOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rk Pharma | NADOLOL | nadolol | TABLET;ORAL | 212856-003 | Sep 13, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Heritage Pharma | NADOLOL | nadolol | TABLET;ORAL | 074255-002 | Jan 24, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Pharms | NADOLOL | nadolol | TABLET;ORAL | 074368-001 | Aug 31, 1994 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma | NADOLOL | nadolol | TABLET;ORAL | 201893-001 | Sep 16, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma | NADOLOL | nadolol | TABLET;ORAL | 201893-002 | Sep 16, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alembic | NADOLOL | nadolol | TABLET;ORAL | 211763-002 | Jun 2, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | NADOLOL | nadolol | TABLET;ORAL | 207761-003 | Jul 28, 2017 | 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 |
Expired US Patents for NADOLOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-004 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-003 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-005 | Oct 28, 1986 | ⤷ Sign Up | ⤷ Sign Up |
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-004 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Uswm | CORGARD | nadolol | TABLET;ORAL | 018063-003 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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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