AMLODIPINE BENZOATE Drug Patent Profile
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Which patents cover Amlodipine Benzoate, and what generic alternatives are available?
Amlodipine Benzoate is a drug marketed by Amneal and is included in one NDA.
The generic ingredient in AMLODIPINE BENZOATE is amlodipine benzoate. There are fifty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amlodipine benzoate profile page.
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Summary for AMLODIPINE BENZOATE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 9 |
| Patent Applications: | 9 |
| DailyMed Link: | AMLODIPINE BENZOATE at DailyMed |
Pharmacology for AMLODIPINE BENZOATE
| Drug Class | Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BENZOATE
Paragraph IV (Patent) Challenges for AMLODIPINE BENZOATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| KATERZIA | Oral Suspension | amlodipine benzoate | 1 mg/mL | 211340 | 1 | 2020-12-29 |
US Patents and Regulatory Information for AMLODIPINE BENZOATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | AMLODIPINE BENZOATE | amlodipine benzoate | SUSPENSION;ORAL | 215035-001 | Jun 13, 2023 | 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 |
