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NITYR Drug Profile
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See Plans and PricingWhen do Nityr patents expire, and what generic alternatives are available?
Nityr is a drug marketed by Cycle Pharms Ltd and is included in one NDA. There is one patent protecting this drug.
This drug has four patent family members in four countries.
The generic ingredient in NITYR is nitisinone. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
US ANDA Litigation and Generic Entry Outlook for Nityr
A generic version of NITYR was approved as nitisinone by NOVITIUM PHARMA on August 26th, 2019.
Summary for NITYR
| International Patents: | 4 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| DailyMed Link: | NITYR at DailyMed |
Pharmacology for NITYR
| Drug Class | 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor |
| Mechanism of Action | Hydroxyphenylpyruvate Dioxygenase Inhibitors Cytochrome P450 2C9 Inhibitors |
US Patents and Regulatory Information for NITYR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle Pharms Ltd | NITYR | nitisinone | TABLET;ORAL | 209449-001 | Jul 26, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Cycle Pharms Ltd | NITYR | nitisinone | TABLET;ORAL | 209449-002 | Jul 26, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Cycle Pharms Ltd | NITYR | nitisinone | TABLET;ORAL | 209449-003 | Jul 26, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 NITYR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2015101794 | Start Trial |
| United Kingdom | 201400117 | Start Trial |
| European Patent Office | 3089740 | Start Trial |
| Canada | 2935013 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NITYR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0591275 | C300198 | Netherlands | Start Trial | PRODUCT NAME: NITISINONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/303/001-003 20050201 |
| 0591275 | 05C0024 | France | Start Trial | PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221 |
| 0591275 | SPC/GB05/030 | United Kingdom | Start Trial | PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
