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Terazosin hydrochloride - Generic Drug Details
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What are the generic sources for terazosin hydrochloride and what is the scope of patent protection?
Terazosin hydrochloride
is the generic ingredient in two branded drugs marketed by Abbott, Apnar Pharma Lp, Beximco Pharms Usa, Heritage Pharma, Hikma, Jubilant Cadista, Mylan, Mylan Technologies, Ranbaxy Labs Ltd, Ivax Sub Teva Pharms, Sandoz, and Teva, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-four drug master file entries for terazosin hydrochloride. Nineteen suppliers are listed for this compound.
Summary for terazosin hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 12 |
| NDAs: | 14 |
| Drug Master File Entries: | 24 |
| Suppliers / Packagers: | 19 |
| Bulk Api Vendors: | 67 |
| Clinical Trials: | 22 |
| Patent Applications: | 1,281 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in terazosin hydrochloride? | terazosin hydrochloride excipients list |
| DailyMed Link: | terazosin hydrochloride at DailyMed |
Recent Clinical Trials for terazosin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Qiang Zhang | Phase 1 |
| University of Iowa | Phase 1 |
| Michael J. Fox Foundation for Parkinson's Research | Phase 1 |
Pharmacology for terazosin hydrochloride
| Drug Class | alpha-Adrenergic Blocker |
| Mechanism of Action | Adrenergic alpha-Antagonists |
Paragraph IV (Patent) Challenges for TERAZOSIN HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| HYTRIN | TABLET;ORAL | terazosin hydrochloride | 019057 | |
| HYTRIN | CAPSULE;ORAL | terazosin hydrochloride | 020347 |
US Patents and Regulatory Information for terazosin hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apnar Pharma Lp | TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | CAPSULE;ORAL | 074823-002 | Mar 30, 1998 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Teva | TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | TABLET;ORAL | 074446-002 | May 18, 2000 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Abbott | HYTRIN | terazosin hydrochloride | TABLET;ORAL | 019057-001 | Aug 7, 1987 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Jubilant Cadista | TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | CAPSULE;ORAL | 075317-003 | Dec 20, 2004 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Beximco Pharms Usa | TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | CAPSULE;ORAL | 075667-004 | Jul 28, 2000 | DISCN | No | 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 terazosin hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbott | HYTRIN | terazosin hydrochloride | TABLET;ORAL | 019057-001 | Aug 7, 1987 | Start Trial | Start Trial |
| Abbott | HYTRIN | terazosin hydrochloride | TABLET;ORAL | 019057-003 | Aug 7, 1987 | Start Trial | Start Trial |
| Abbott | HYTRIN | terazosin hydrochloride | CAPSULE;ORAL | 020347-004 | Dec 14, 1994 | Start Trial | Start Trial |
| Abbott | HYTRIN | terazosin hydrochloride | CAPSULE;ORAL | 020347-003 | Dec 14, 1994 | Start Trial | Start Trial |
| Abbott | HYTRIN | terazosin hydrochloride | TABLET;ORAL | 019057-003 | Aug 7, 1987 | Start Trial | Start Trial |
| >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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