Amlodipine besylate; benazepril hydrochloride - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for amlodipine besylate; benazepril hydrochloride and what is the scope of patent protection?
Amlodipine besylate; benazepril hydrochloride
is the generic ingredient in two branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Inc, Lupin Pharms, Mylan, Strides Pharma, Teva Pharms, Watson Labs, Watson Labs Inc, and Novartis, 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: | 1 |
Clinical Trials: | 6 |
Patent Applications: | 46 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for amlodipine besylate; benazepril hydrochloride |
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 |
See Plans and Pricing | See Plans and Pricing | 10MG; 20MG | CAPSULE; ORAL |
See Plans and Pricing | See Plans and Pricing | 5MG; 20MG | CAPSULE; ORAL |
See Plans and Pricing | See Plans and Pricing | 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.
Pharmacology for amlodipine besylate; benazepril hydrochloride
Drug Class | Angiotensin Converting Enzyme Inhibitor Dihydropyridine Calcium Channel Blocker Calcium Channel Blocker |
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Physiological Effect | Decreased Blood Pressure |
Anatomical Therapeutic Chemical (ATC) Classes for amlodipine besylate; benazepril hydrochloride
Paragraph IV (Patent) Challenges 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 091431-002 | Dec 30, 2013 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Mylan | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 079047-002 | Jul 5, 2011 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Strides Pharma | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 078381-006 | Jul 29, 2010 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 |
---|---|---|---|---|---|---|---|
Novartis | LOTREL | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 020364-007 | Apr 11, 2006 | See Plans and Pricing | See Plans and Pricing |
Novartis | LOTREL | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 020364-005 | Jun 20, 2002 | See Plans and Pricing | See Plans and Pricing |
Novartis | LOTREL | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 020364-002 | Mar 3, 1995 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:






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.