NITISINONE - Generic Drug Details
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What are the generic drug sources for nitisinone and what is the scope of patent protection?
Nitisinone
is the generic ingredient in three branded drugs marketed by Eton, Medunik, Novitium Pharma, Torrent, Swedish Orphan, and Cycle, and is included in seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Nitisinone has thirty-eight patent family members in twenty-five countries.
There are two drug master file entries for nitisinone. Six suppliers are listed for this compound.
Summary for NITISINONE
International Patents: | 38 |
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 6 |
NDAs: | 7 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 125 |
Clinical Trials: | 16 |
Patent Applications: | 784 |
Drug Prices: | Drug price trends for NITISINONE |
What excipients (inactive ingredients) are in NITISINONE? | NITISINONE excipients list |
DailyMed Link: | NITISINONE at DailyMed |
Recent Clinical Trials for NITISINONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sutphin Drugs | N/A |
Cycle Pharmaceuticals Ltd. | Phase 1 |
Parexel | Phase 1 |
Pharmacology for NITISINONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Swedish Orphan | ORFADIN | nitisinone | SUSPENSION;ORAL | 206356-001 | Apr 22, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Medunik | NITISINONE | nitisinone | CAPSULE;ORAL | 212390-003 | May 26, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-002 | Jan 18, 2002 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cycle | NITYR | nitisinone | TABLET;ORAL | 209449-002 | Jul 26, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Eton | NITISINONE | nitisinone | CAPSULE;ORAL | 216201-003 | May 25, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novitium Pharma | NITISINONE | nitisinone | CAPSULE;ORAL | 211041-001 | Aug 26, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 NITISINONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-002 | Jan 18, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-001 | Jan 18, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-003 | Jan 18, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-002 | Jan 18, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-003 | Jan 18, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-001 | Jan 18, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for NITISINONE
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. |
Withdrawn | 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 NITISINONE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1117273 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2012177214 | ⤷ Sign Up | |
Spain | 2806739 | ⤷ Sign Up | |
Australia | 2012273515 | Liquid pharmaceutical composition comprising nitisinone | ⤷ Sign Up |
Canada | 2838039 | COMPOSITION PHARMACEUTIQUE LIQUIDE COMPRENANT DE LA NITISINONE (LIQUID PHARMACEUTICAL COMPOSITION COMPRISING NITISINONE) | ⤷ Sign Up |
Cyprus | 1123394 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NITISINONE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0591275 | C300198 | Netherlands | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221 |
0591275 | SPC/GB05/030 | United Kingdom | ⤷ Sign Up | 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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