AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for amlodipine besylate; benazepril hydrochloride and what is the scope of freedom to operate?
Amlodipine besylate; benazepril hydrochloride
is the generic ingredient in two branded drugs marketed by Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Norvium Bioscience, Strides Pharma, Teva Pharms, Watson Labs, Watson Labs Inc, and Sandoz, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 11 |
NDAs: | 13 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 6 |
Patent Applications: | 39 |
DailyMed Link: | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Shanghai Jiao Tong University School of Medicine | Phase 4 |
Novartis Pharmaceuticals | Phase 4 |
Dr. Reddy's Laboratories Limited | Phase 1 |
See all AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE clinical trials
Generic filers with tentative approvals for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 5MG; 10MG | CAPSULE; ORAL |
⤷ Sign Up | ⤷ Sign Up | 2.5MG; 10MG | CAPSULE; ORAL |
⤷ Sign Up | ⤷ Sign Up | 10MG; 20MG | 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.
Pharmacology for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LOTREL | Capsules | amlodipine besylate; benazepril hydrochloride | 5 mg/40 mg and 10 mg/40 mg | 020364 | 1 | 2006-11-17 |
LOTREL | Capsules | amlodipine besylate; benazepril hydrochloride | 2.5 mg/10 mg 5 mg/10 mg 5 mg/20 mg 10 mg/20 mg | 020364 | 1 | 2004-06-09 |
US Patents and Regulatory Information for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
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 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 090149-001 | Jul 5, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys Labs Inc | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 090149-002 | Jul 5, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Norvium Bioscience | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 077375-004 | May 21, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | LOTREL | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 020364-002 | Mar 3, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | LOTREL | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 020364-004 | Mar 3, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | LOTREL | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 020364-002 | Mar 3, 1995 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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