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TENORMIN Drug Profile
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When do Tenormin patents expire, and what generic alternatives are available?
Tenormin is a drug marketed by Astrazeneca and Alvogen and is included in two NDAs.
The generic ingredient in TENORMIN is atenolol. There are thirty-four drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the atenolol profile page.
US ANDA Litigation and Generic Entry Outlook for Tenormin
A generic version of TENORMIN was approved as atenolol by ALVOGEN on July 15th, 1988.
Summary for TENORMIN
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 125 |
| Clinical Trials: | 7 |
| Patent Applications: | 4,488 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TENORMIN |
| DailyMed Link: | TENORMIN at DailyMed |
Recent Clinical Trials for TENORMIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| High Risk Obstetrical Consultants | Early Phase 1 |
| University of Tennessee Graduate School of Medicine | Early Phase 1 |
| BioHealthonomics Inc. | Phase 2 |
Pharmacology for TENORMIN
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
US Patents and Regulatory Information for TENORMIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | TENORMIN | atenolol | INJECTABLE;INJECTION | 019058-001 | Sep 13, 1989 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Alvogen | TENORMIN | atenolol | TABLET;ORAL | 018240-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Alvogen | TENORMIN | atenolol | TABLET;ORAL | 018240-004 | Apr 9, 1990 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Alvogen | TENORMIN | atenolol | TABLET;ORAL | 018240-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| >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 TENORMIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alvogen | TENORMIN | atenolol | TABLET;ORAL | 018240-002 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Alvogen | TENORMIN | atenolol | TABLET;ORAL | 018240-004 | Apr 9, 1990 | Start Trial | Start Trial |
| Alvogen | TENORMIN | atenolol | TABLET;ORAL | 018240-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Alvogen | TENORMIN | atenolol | TABLET;ORAL | 018240-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TENORMIN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 376788 | Start Trial |
| Austria | 304472 | Start Trial |
| Austria | 305245 | Start Trial |
| Czechoslovakia | 153063 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
