DrugPatentWatch Database Preview
AKYNZEO Drug Profile
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 thirteen patents protecting this drug.
This drug has two hundred and ten 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: | 210 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 5 |
| 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
Generic Entry Dates for AKYNZEO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for AKYNZEO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS |
*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.
Recent Clinical Trials for AKYNZEO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| VIFORFRANCE | Phase 4 |
| Christina Ruhlmann | Phase 2/Phase 3 |
| Helsinn Healthcare SA | Phase 3 |
Recent Litigation for AKYNZEO
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. | 2015-12-04 |
| HELSINN HEALTHCARE S.A. v. HOSPIRA, INC. | 2015-03-23 |
| Helsinn Healthcare SA v. Cipla Ltd. | 2013-04-16 |
Pharmacology for AKYNZEO
US Patents and Regulatory Information for AKYNZEO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Helsinn Hlthcare | AKYNZEO | netupitant; palonosetron hydrochloride | CAPSULE;ORAL | 205718-001 | Oct 10, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Helsinn Hlthcare | AKYNZEO | netupitant; palonosetron hydrochloride | CAPSULE;ORAL | 205718-001 | Oct 10, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Helsinn Hlthcare | AKYNZEO | netupitant; palonosetron hydrochloride | CAPSULE;ORAL | 205718-001 | Oct 10, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Helsinn Hlthcare | AKYNZEO | fosnetupitant chloride hydrochloride; palonosetron hydrochloride | POWDER;INTRAVENOUS | 210493-001 | Apr 19, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AKYNZEO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Jordan | 2294 | Start Trial |
| Sweden | 1035115 | Start Trial |
| China | 106421793 | Start Trial |
| Hungary | E029677 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AKYNZEO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1035115 | 2015/030 | Ireland | Start Trial | PRODUCT NAME: NETUPITANT OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1001 20150527 |
| 1035115 | 43/2015 | Austria | Start Trial | PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: EU/1/15/1001 20150527 |
| 1035115 | 15C0049 | France | Start Trial | PRODUCT NAME: NETUPITANT OU L'UN DE SES SELS D'ADDITION D'ACIDES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1001 20150529 |
| 1035115 | 300758 | Netherlands | Start Trial | PRODUCT NAME: NETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1001 20150527 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
