TRANDOLAPRIL - Generic Drug Details
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What are the generic drug sources for trandolapril and what is the scope of patent protection?
Trandolapril
is the generic ingredient in four branded drugs marketed by Abbvie, Aurobindo Pharma, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, Invagen Pharms, Lupin, Mylan, Teva Pharms, Watson Labs, and Glenmark Generics, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for trandolapril. Five suppliers are listed for this compound.
Summary for TRANDOLAPRIL
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 12 |
| NDAs: | 13 |
| Drug Master File Entries: | 10 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 75 |
| Clinical Trials: | 18 |
| Patent Applications: | 6,612 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for TRANDOLAPRIL |
| What excipients (inactive ingredients) are in TRANDOLAPRIL? | TRANDOLAPRIL excipients list |
| DailyMed Link: | TRANDOLAPRIL at DailyMed |
Recent Clinical Trials for TRANDOLAPRIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Nebraska | Phase 4 |
| Hospital Authority, Hong Kong | Phase 4 |
| Assaf-Harofeh Medical Center |
Pharmacology for TRANDOLAPRIL
| Drug Class | Angiotensin Converting Enzyme Inhibitor |
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Paragraph IV (Patent) Challenges for TRANDOLAPRIL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MAVIK | Tablets | trandolapril | 1 mg, 2 mg and 4 mg | 020528 | 1 | 2004-10-04 |
US Patents and Regulatory Information for TRANDOLAPRIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | TRANDOLAPRIL | trandolapril | TABLET;ORAL | 077805-001 | Jun 12, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan | TRANDOLAPRIL | trandolapril | TABLET;ORAL | 078346-002 | Apr 28, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Epic Pharma | TRANDOLAPRIL | trandolapril | TABLET;ORAL | 078508-003 | Jun 18, 2008 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Chartwell Molecular | TRANDOLAPRIL | trandolapril | TABLET;ORAL | 077307-002 | Jun 12, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Epic Pharma | TRANDOLAPRIL | trandolapril | TABLET;ORAL | 078508-001 | Jun 18, 2008 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Invagen Pharms | TRANDOLAPRIL | trandolapril | TABLET;ORAL | 078320-003 | Jun 12, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie | MAVIK | trandolapril | TABLET;ORAL | 020528-002 | Apr 26, 1996 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 TRANDOLAPRIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | MAVIK | trandolapril | TABLET;ORAL | 020528-003 | Apr 26, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | MAVIK | trandolapril | TABLET;ORAL | 020528-003 | Apr 26, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | MAVIK | trandolapril | TABLET;ORAL | 020528-001 | Apr 26, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | MAVIK | trandolapril | TABLET;ORAL | 020528-002 | Apr 26, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | MAVIK | trandolapril | TABLET;ORAL | 020528-001 | Apr 26, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | MAVIK | trandolapril | TABLET;ORAL | 020528-003 | Apr 26, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | MAVIK | trandolapril | TABLET;ORAL | 020528-002 | Apr 26, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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