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 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. Six 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 |
Raw Ingredient (Bulk) Api Vendors: | 125 |
Patent Applications: | 664 |
Drug Prices: | Drug price information for NITYR |
What excipients (inactive ingredients) are in NITYR? | NITYR excipients list |
DailyMed Link: | NITYR at DailyMed |


US Patents and Regulatory Information for NITYR
NITYR is protected by one US patents.
Patents protecting NITYR
Pharmaceutical composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | NITYR | nitisinone | TABLET;ORAL | 209449-001 | Jul 26, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Cycle | NITYR | nitisinone | TABLET;ORAL | 209449-002 | Jul 26, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Cycle | NITYR | nitisinone | TABLET;ORAL | 209449-003 | Jul 26, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for NITYR
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
MendeliKABS Europe Ltd | Nitisinone MDK (previously Nitisinone MendeliKABS) | nitisinone | EMEA/H/C/004281 Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine. |
Authorised | yes | no | no | 2017-08-24 | |
Cycle Pharmaceuticals (Europe) Ltd | Nityr | nitisinone | EMEA/H/C/004582 Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. |
Authorised | yes | no | no | 2018-07-26 | |
Swedish Orphan Biovitrum International AB | Orfadin | nitisinone | EMEA/H/C/000555 Hereditary tyrosinemia type 1 (HT 1)Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.Alkaptonuria (AKU)Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU). |
Authorised | no | no | no | 2005-02-21 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for NITYR
See the table below for patents covering NITYR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Lithuania | 3089740 | ⤷ Try a Trial | |
Spain | 2806739 | ⤷ Try a Trial | |
Portugal | 3089740 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NITYR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0591275 | 05C0024 | France | ⤷ Try a Trial | PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221 |
0591275 | C300198 | Netherlands | ⤷ Try a 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 | SPC/GB05/030 | United Kingdom | ⤷ Try a 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 |