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Harmony Company Profile
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What is the competitive landscape for HARMONY, and what generic alternatives to HARMONY drugs are available?
HARMONY has one approved drug.
There are five US patents protecting HARMONY drugs.
There are seventy-two patent family members on HARMONY drugs in thirty-two countries and twelve supplementary protection certificates in eleven countries.
Summary for Harmony
| International Patents: | 72 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Ingredients: | 1 |
| NDAs: | 1 |
Drugs and US Patents for Harmony
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | RX | Yes | Yes | 8,207,197 | Start Trial | Y | Y | Start Trial | ||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | RX | Yes | Yes | 7,910,605 | Start Trial | Start Trial | ||||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | RX | Yes | No | Start Trial | Start Trial | |||||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | RX | Yes | No | 8,207,197 | Start Trial | Y | Y | Start Trial | ||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | RX | Yes | No | 7,910,605 | Start Trial | Start Trial | ||||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | RX | Yes | Yes | Start Trial | Start Trial | |||||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | RX | Yes | Yes | 8,354,430 | 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 |
International Patents for Harmony Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 5955872 | Start Trial |
| Japan | 2014062126 | Start Trial |
| Australia | 2006228413 | Start Trial |
| Germany | 602005005941 | Start Trial |
| Montenegro | 01103 | Start Trial |
| South Africa | 200708086 | Start Trial |
| South Korea | 101308527 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Harmony Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1428820 | 16C0038 | France | Start Trial | PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/15/1068 20160331 |
| 1428820 | 40/2016 | Austria | Start Trial | PRODUCT NAME: PITOLISANT UND SEINE PHARMAZEUTISCH VERTRAEGLICHEN SALZE EINSCHLIESSLICH DEM HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 (MITTEILUNG) 20160404 |
| 1428820 | 499 | Finland | Start Trial | |
| 1428820 | 122016000073 | Germany | Start Trial | PRODUCT NAME: PITOLISANT UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE, WIE DAS HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 20160331 |
| 1428820 | CA 2016 00042 | Denmark | Start Trial | PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404 |
| 1428820 | 2016/038 | Ireland | Start Trial | PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068 20160331 |
| 1428820 | SPC/GB16/052 | United Kingdom | Start Trial | PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTERED: UK EU/1/15/1068 20160404 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
