DrugPatentWatch Database Preview
AKYNZEO Drug Profile
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When do Akynzeo patents expire, and what generic alternatives are available?
Akynzeo is a drug marketed by Helsinn Hlthcare and is included in two NDAs. There are eleven patents protecting this drug.
This drug has two hundred and five patent family members in sixty-seven countries.
The generic ingredient in AKYNZEO is fosnetupitant chloride hydrochloride; palonosetron hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fosnetupitant chloride hydrochloride; palonosetron hydrochloride profile page.
Summary for AKYNZEO
| International Patents: | 205 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AKYNZEO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AKYNZEO |
| DailyMed Link: | AKYNZEO at DailyMed |
Generic Entry Opportunity Date for AKYNZEO
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for AKYNZEO
US Patents and Regulatory Information for AKYNZEO
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Expired US Patents for AKYNZEO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Helsinn Hlthcare | AKYNZEO | netupitant; palonosetron hydrochloride | CAPSULE;ORAL | 205718-001 | Oct 10, 2014 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for AKYNZEO
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,479,483 | 4-phenyl-pyridine derivatives | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for AKYNZEO
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Denmark | 1035115 | ➤ Sign Up |
| Taiwan | I288746 | ➤ Sign Up |
| Ukraine | 105817 | ➤ Sign Up |
| Chile | 2014001280 | ➤ Sign Up |
| Uruguay | 32314 | ➤ Sign Up |
| Tunisia | 2012000170 | ➤ Sign Up |
| Dominican Republic | P2012000138 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for AKYNZEO
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 15/030 | Ireland | ➤ Sign Up | PRODUCT NAME: NETUPITANT OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1001 20150527 |
| 0758 | Netherlands | ➤ Sign Up | PRODUCT NAME: NETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1001 20150527 |
| 2015036,C1035115 | Lithuania | ➤ Sign Up | PRODUCT NAME: NETUPITANTAS; REGISTRATION NO/DATE: EU/1/15/1001 20150527 |
| 1035115/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: SWISSMEDIC 65499 06.11.2015 |
| 745 | Luxembourg | ➤ Sign Up | PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527 |
| /2015 | Austria | ➤ Sign Up | PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: EU/1/15/1001 20150527 |
| 2015036 | Lithuania | ➤ Sign Up | PRODUCT NAME: NETUPITANTUM; REGISTRATION NO/DATE: EU/1/15/1001 20150527 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
