NITYR Drug Patent Profile
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When 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 thirteen patent family members in thirteen countries.
The generic ingredient in NITYR is nitisinone. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
DrugPatentWatch® 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: | 13 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Drug Prices: | Drug price information for NITYR |
| What excipients (inactive ingredients) are in NITYR? | NITYR excipients list |
| DailyMed Link: | NITYR at DailyMed |
Pharmacology for NITYR
| Drug Class | 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor |
| Mechanism of Action | Cytochrome P450 2C9 Inhibitors Hydroxyphenylpyruvate Dioxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for NITYR
US Patents and Regulatory Information for NITYR
NITYR is protected by one US patents.
Patents protecting NITYR
Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HEREDITARY TYROSINEMIA TYPE 1 (HT-1) IN COMBINATION WITH DIETARY RESTRICTION OF TYROSINE AND PHENYLALANINE
| 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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Cycle Pharms Ltd | NITYR | nitisinone | TABLET;ORAL | 209449-002 | Jul 26, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Cycle Pharms Ltd | NITYR | nitisinone | TABLET;ORAL | 209449-003 | Jul 26, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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
See the table below for patents covering NITYR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2015101794 | See Plans and Pricing | |
| European Patent Office | 3089740 | COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION) | See Plans and Pricing |
| Spain | 2806739 | See Plans and Pricing | |
| Denmark | 3089740 | See Plans and Pricing | |
| Lithuania | 3089740 | See Plans and Pricing | |
| Serbia | 60551 | FARMACEUTSKA KOMPOZICIJA (PHARMACEUTICAL COMPOSITION) | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NITYR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0591275 | C300198 | Netherlands | See Plans and Pricing | 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 | See Plans and Pricing | PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221 |
| 0591275 | SPC/GB05/030 | United Kingdom | See Plans and Pricing | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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