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Ivabradine - Generic Drug Details
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What are the generic drug sources for ivabradine and what is the scope of patent protection?
Ivabradine
is the generic ingredient in one branded drug marketed by Amgen Inc and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivabradine has ninety-nine patent family members in forty-three countries.
There are nine drug master file entries for ivabradine. One supplier is listed for this compound.
Summary for ivabradine
| International Patents: | 99 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 9 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 30 |
| Clinical Trials: | 68 |
| Patent Applications: | 677 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ivabradine |
| DailyMed Link: | ivabradine at DailyMed |
Recent Clinical Trials for ivabradine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital, Geneva | Phase 4 |
| Damanhour University | Phase 4 |
| Ministero della Salute, Italy | Phase 2 |
Pharmacology for ivabradine
| Drug Class | Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker |
| Mechanism of Action | Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists |
US Patents and Regulatory Information for ivabradine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-002 | Apr 15, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-001 | Apr 15, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-001 | Apr 15, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-002 | Apr 15, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Amgen Inc | CORLANOR | ivabradine | SOLUTION;ORAL | 209964-001 | Apr 22, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ivabradine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 173957 | Start Trial |
| Croatia | P20080406 | Start Trial |
| South Korea | 100835447 | Start Trial |
| Ecuador | SP066375 | Start Trial |
| Eurasian Patent Organization | 200600320 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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.
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