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AKYNZEO Drug Profile
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Which patents cover Akynzeo, and what generic alternatives are available?
Akynzeo is a drug marketed by Helsinn Hlthcare and is included in two NDAs. There are seventeen patents protecting this drug.
This drug has two hundred and fifty-two patent family members in sixty-eight 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.
DrugPatentWatch® Generic Entry Outlook for Akynzeo
Akynzeo will be eligible for patent challenges on April 19, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 25, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for AKYNZEO
| International Patents: | 252 |
| US Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 6 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AKYNZEO |
| What excipients (inactive ingredients) are in AKYNZEO? | AKYNZEO excipients list |
| DailyMed Link: | AKYNZEO at DailyMed |
DrugPatentWatch® Estimated 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 |
|---|---|
| HK inno.N Corporation | Phase 1 |
| VIFORFRANCE | Phase 4 |
| Christina Ruhlmann | Phase 2/Phase 3 |
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 | fosnetupitant chloride hydrochloride; palonosetron hydrochloride | SOLUTION;INTRAVENOUS | 210493-002 | May 27, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Helsinn Hlthcare | AKYNZEO | fosnetupitant chloride hydrochloride; palonosetron hydrochloride | SOLUTION;INTRAVENOUS | 210493-002 | May 27, 2020 | RX | Yes | Yes | Start Trial | Start Trial | 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 | ||||
| >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 |
|---|---|---|
| Bulgaria | 64554 | Start Trial |
| Poland | 2785706 | Start Trial |
| Hong Kong | 1214147 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AKYNZEO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2785706 | 301047 | Netherlands | Start Trial | PRODUCT NAME: FOSNETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FOSNETUPITANTCHLORIDEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1001 20200318 |
| 1035115 | CR 2015 00044 | Denmark | Start Trial | PRODUCT NAME: NETUPITANT; REG. NO/DATE: EU/1/15/1001 20150529 |
| 2785706 | 122020000050 | Germany | Start Trial | PRODUCT NAME: FOSNETUPITANT; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
