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 two branded drugs marketed by Amgen Inc, Annora Pharma, and Ingenus Pharms Llc, and is included in four NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivabradine has ninety-seven patent family members in forty-two countries.
There are nine drug master file entries for ivabradine. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for ivabradine
International Patents: | 97 |
US Patents: | 8 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 4 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 43 |
Clinical Trials: | 78 |
Patent Applications: | 1,487 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ivabradine |
What excipients (inactive ingredients) are in ivabradine? | ivabradine excipients list |
DailyMed Link: | ivabradine at DailyMed |
Recent Clinical Trials for ivabradine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Uniformed Services University of the Health Sciences | Phase 4 |
The Young Investigator Group of Cardiovascular Research | Phase 3 |
Vanderbilt University Medical Center | Phase 3 |
Generic filers with tentative approvals for IVABRADINE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 7.5MG | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | 5MG | TABLET;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 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
EU/EMA Drug Approvals for ivabradine
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Accord Healthcare S.L.U. | Ivabradine Accord | ivabradine | EMEA/H/C/004241 Symptomatic treatment of chronic stable angina pectorisIvabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm.Ivabradine is indicated :- in adults unable to tolerate or with a contra-indication to the use of beta-blockers- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. (see section 5.1) |
Authorised | yes | no | no | 2017-05-22 | |
Zentiva, k.s. | Ivabradine Zentiva | ivabradine | EMEA/H/C/004117 Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:, , , in adults unable to tolerate or with a contra-indication to the use of beta-blockers, , , or, , , in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated., , |
Authorised | yes | no | no | 2016-11-11 | |
Les Laboratoires Servier | Corlentor | ivabradine | EMEA/H/C/000598 Symptomatic treatment of chronic stable angina pectorisIvabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. |
Authorised | no | no | no | 2005-10-25 | |
Les Laboratoires Servier | Procoralan | ivabradine | EMEA/H/C/000597 Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated :in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. |
Authorised | no | no | no | 2005-10-25 | |
"Anpharm" Przedsiębiorstwo Farmaceutyczne S.A. | Ivabradine Anpharm | ivabradine | EMEA/H/C/004187 Symptomatic treatment of chronic stable angina pectorisIvabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:in adults unable to tolerate or with a contra-indication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal betablocker dose.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. |
Authorised | no | no | no | 2015-09-08 | |
JensonR+ Limited | Ivabradine JensonR | ivabradine | EMEA/H/C/004217 Symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated: - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated., |
Withdrawn | yes | no | no | 2016-11-11 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ivabradine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Georgia, Republic of | P20084465 | BETA-CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE, PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT | See Plans and Pricing |
Australia | 2006200857 | y-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it | See Plans and Pricing |
Saudi Arabia | 2399 | γ -Crystalline Form of Ivabradine Hydrochloride, a Process for its Preparation and Pharmaceutical Compositions Containing It | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2006092492 | See Plans and Pricing | |
Taiwan | 200640873 | &bgr-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it | See Plans and Pricing |
France | 2882555 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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