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Desipramine hydrochloride - Generic Drug Details
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What are the generic drug sources for desipramine hydrochloride and what is the scope of freedom to operate?
Desipramine hydrochloride
is the generic ingredient in three branded drugs marketed by Sanofi Aventis Us, Actavis Totowa, Amneal Pharms Co, Ani Pharms Inc, Heritage Pharms Inc, Novast Labs, Sandoz, Usl Pharma, and Us Pharm Holdings, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for desipramine hydrochloride. Seven suppliers are listed for this compound.
Summary for desipramine hydrochloride
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 9 |
| NDAs: | 22 |
| Drug Master File Entries: | 9 |
| Suppliers / Packagers: | 7 |
| Bulk Api Vendors: | 67 |
| Clinical Trials: | 60 |
| Patent Applications: | 1,981 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | desipramine hydrochloride at DailyMed |
Recent Clinical Trials for desipramine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Duke University | Phase 4 |
| Stanford University | Phase 4 |
| State University of New York at Buffalo | Phase 4 |
Pharmacology for desipramine hydrochloride
| Drug Class | Tricyclic Antidepressant |
Medical Subject Heading (MeSH) Categories for desipramine hydrochloride
US Patents and Regulatory Information for desipramine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novast Labs | DESIPRAMINE HYDROCHLORIDE | desipramine hydrochloride | TABLET;ORAL | 204963-001 | Dec 26, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Usl Pharma | DESIPRAMINE HYDROCHLORIDE | desipramine hydrochloride | TABLET;ORAL | 071865-001 | Sep 9, 1987 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Us Pharm Holdings | NORPRAMIN | desipramine hydrochloride | TABLET;ORAL | 014399-004 | 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 desipramine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Us Pharm Holdings | NORPRAMIN | desipramine hydrochloride | TABLET;ORAL | 014399-007 | Feb 11, 1982 | Start Trial | Start Trial |
| Us Pharm Holdings | NORPRAMIN | desipramine hydrochloride | TABLET;ORAL | 014399-004 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Sanofi Aventis Us | PERTOFRANE | desipramine hydrochloride | CAPSULE;ORAL | 013621-001 | Approved Prior to Jan 1, 1982 | 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.
ISSN: 2162-2639
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