IVABRADINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Ivabradine Hydrochloride, and what generic alternatives are available?
Ivabradine Hydrochloride is a drug marketed by Annora Pharma, Bionpharma, Ingenus Pharms Llc, and Zydus Pharms. and is included in four NDAs.
The generic ingredient in IVABRADINE HYDROCHLORIDE is ivabradine hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ivabradine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ivabradine Hydrochloride
A generic version of IVABRADINE HYDROCHLORIDE was approved as ivabradine hydrochloride by INGENUS PHARMS LLC on December 30th, 2021.
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Summary for IVABRADINE HYDROCHLORIDE
Recent Clinical Trials for IVABRADINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Second Affiliated Hospital of Guangzhou Medical University | Phase 4 |
| Uniformed Services University of the Health Sciences | Phase 4 |
| The Young Investigator Group of Cardiovascular Research | Phase 3 |
Pharmacology for IVABRADINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for IVABRADINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for IVABRADINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CORLANOR | Tablets | ivabradine hydrochloride | 5 mg and 7.5 mg | 206143 | 6 | 2019-10-15 |
US Patents and Regulatory Information for IVABRADINE HYDROCHLORIDE
IVABRADINE HYDROCHLORIDE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting IVABRADINE HYDROCHLORIDE
PATENT CHALLENGE
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Annora Pharma | IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 213366-001 | Oct 5, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 213442-001 | Nov 29, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bionpharma | IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 213276-002 | Sep 5, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 213442-002 | Nov 29, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Annora Pharma | IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 213366-002 | Oct 5, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bionpharma | IVABRADINE HYDROCHLORIDE | ivabradine hydrochloride | TABLET;ORAL | 213276-001 | Sep 5, 2024 | AB | RX | 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 |
