AMLODIPINE MALEATE - Generic Drug Details
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What are the generic drug sources for amlodipine maleate and what is the scope of patent protection?
Amlodipine maleate
is the generic ingredient in one branded drug marketed by Dr Reddys Labs Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for amlodipine maleate. There is one tentative approval for this compound.
Summary for AMLODIPINE MALEATE
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 65 |
Clinical Trials: | 6 |
Patent Applications: | 821 |
Formulation / Manufacturing: | see details |
DailyMed Link: | AMLODIPINE MALEATE at DailyMed |
Recent Clinical Trials for AMLODIPINE MALEATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
CSPC Ouyi Pharmaceutical Co., Ltd. | Phase 1 |
Conjupro Biotherapeutics, Inc. | Phase 1 |
Conjupro Biotherapeutics | Phase 1 |
Generic filers with tentative approvals for AMLODIPINE MALEATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 10MG; 20MG | CAPSULE; ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 5MG; 20MG | CAPSULE; ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 5MG; 10MG | CAPSULE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for AMLODIPINE MALEATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dr Reddys Labs Inc | AMVAZ | amlodipine maleate | TABLET;ORAL | 021435-003 | Oct 31, 2003 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Dr Reddys Labs Inc | AMVAZ | amlodipine maleate | TABLET;ORAL | 021435-002 | Oct 31, 2003 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Dr Reddys Labs Inc | AMVAZ | amlodipine maleate | TABLET;ORAL | 021435-001 | Oct 31, 2003 | DISCN | No | 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 |