ORFADIN Drug Patent Profile
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Which patents cover Orfadin, and what generic alternatives are available?
Orfadin is a drug marketed by Swedish Orphan and is included in two NDAs. There is one patent protecting this drug.
This drug has twenty-four patent family members in twenty-two countries.
The generic ingredient in ORFADIN 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 Orfadin
A generic version of ORFADIN was approved as nitisinone by NOVITIUM PHARMA on August 26th, 2019.
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Summary for ORFADIN
| International Patents: | 24 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 125 |
| Clinical Trials: | 12 |
| Patent Applications: | 499 |
| Drug Prices: | Drug price information for ORFADIN |
| What excipients (inactive ingredients) are in ORFADIN? | ORFADIN excipients list |
| DailyMed Link: | ORFADIN at DailyMed |
US Patents and Regulatory Information for ORFADIN
ORFADIN is protected by one US patents.
Patents protecting ORFADIN
Liquid pharmaceutical composition comprising nitisinone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-001 | Jan 18, 2002 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-004 | Jun 13, 2016 | AB | RX | Yes | Yes | ⤷ 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 | |||
| Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-003 | Jan 18, 2002 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Swedish Orphan | ORFADIN | nitisinone | SUSPENSION;ORAL | 206356-001 | Apr 22, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 ORFADIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-001 | 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 | 021232-003 | 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 | 021232-001 | Jan 18, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ORFADIN
| 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 ORFADIN
When does loss-of-exclusivity occur for ORFADIN?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 12273515
Patent: Liquid pharmaceutical composition comprising nitisinone
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2013033008
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 38039
Patent: COMPOSITION PHARMACEUTIQUE LIQUIDE COMPRENANT DE LA NITISINONE (LIQUID PHARMACEUTICAL COMPOSITION COMPRISING NITISINONE)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 13003630
Patent: Formulacion farmaceutica liquida que comprende nitisinona y un tampon de acido citrico que tien un ph en el rango de 2,5 a 3,5, de preferencia 3,0; y su uso para el tratamiento de tirosemia, enfermedad de parkinson, depresion, entre otros.
Estimated Expiration: ⤷ Sign Up
China
Patent: 3747781
Patent: Liquid pharmaceutical composition comprising nitisinone
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0160286
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 17273
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 23320
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 23320
Patent: COMPOSITION PHARMACEUTIQUE LIQUIDE COMPRENANT DE LA NITISINONE (LIQUID PHARMACEUTICAL COMPOSITION COMPRISING NITISINONE)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 27304
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9677
Patent: פורמולציה נוזלית המתאימה למתן דרך הפה המכילה תרחיף של גבישים זעירים של 2 (2-ניטרו-טריפלואורומתילבנזויל)- 1,3 -ציקלוהקסאנדיאון ובופר חומצה ציטרית (Liquid formulation suitable for oral administration comprising a suspension of micronized 2(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexandione and citric acid buffer)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 38132
Estimated Expiration: ⤷ Sign Up
Patent: 14517067
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 13014567
Patent: COMPOSICION FARMACEUTICA LIQUIDA QUE COMPRENDE NITISINONA. (LIQUID PHARMACEUTICAL COMPOSITION COMPRISING NITISINONE.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8332
Patent: Liquid pharmaceutical composition comprising nitisinone
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 23320
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 05301
Patent: ЖИДКАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ НИТИЗИНОН (LIQUID PHARMACEUTICAL COMPOSITION CONTAINING NITIZINONE)
Estimated Expiration: ⤷ Sign Up
Patent: 14101990
Patent: ЖИДКАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ НИТИЗИНОН
Estimated Expiration: ⤷ Sign Up
San Marino
Patent: 01600097
Patent: COMPOSIZIONE FARMACEUTICA LIQUIDA CHE COMPRENDE NITISONE
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 632
Patent: TEČNA FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI NITIZINON (LIQUID PHARMACEUTICAL COMPOSITION COMPRISING NITISINONE)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 23320
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 66787
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 0979
Patent: РІДКА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЯКА ВКЛЮЧАЄ НІТИЗИНОН (LIQUID PHARMACEUTICAL FORMULATION COMPRISING NITISINONE)
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ORFADIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | E027304 | ⤷ Sign Up | |
| European Patent Office | 0135191 | CERTAIN 2-(2-SUBSTITUTED BENZOYL)-1,3-CYCLOHEXANEDIONES | ⤷ Sign Up |
| Slovenia | 2723320 | ⤷ Sign Up | |
| South Africa | 8407256 | ⤷ Sign Up | |
| Spain | 2129448 | ⤷ Sign Up | |
| Denmark | 594685 | ⤷ Sign Up | |
| Spain | 8608472 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ORFADIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0591275 | 05C0024 | France | ⤷ Sign Up | PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221 |
| 0186118 | C350003 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MESOTRIONE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: 12204N 20010504 |
| 0591275 | 24/2005 | Austria | ⤷ Sign Up | PRODUCT NAME: NITISINON ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/04/303/001- EU/1/04/303/003 20050221 |
| 0591275 | 91180 | Luxembourg | ⤷ Sign Up | 91180, EXPIRES: 20170618 |
| 0186118 | SPC/GB05/037 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF TERBUTHYLAZINE AND MESOTRIONE; REGISTERED: DK 1-186 20050203; UK 0805 OF 2005 20050425 |
| 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 |
| 0591275 | CA 2005 00029 | Denmark | ⤷ Sign Up | |
| >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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