Choline fenofibrate - Generic Drug Details
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What are the generic drug sources for choline fenofibrate and what is the scope of freedom to operate?
Choline fenofibrate
is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Alembic, Anchen Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Graviti Pharms, Impax Labs Inc, Macleods Pharms Ltd, Micro Labs, Mylan Pharms Inc, Twi Pharms, Yichang Humanwell, and Abbvie, and is included in thirteen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Choline fenofibrate has nineteen patent family members in eleven countries.
There are ten drug master file entries for choline fenofibrate. Twelve suppliers are listed for this compound.
Summary for choline fenofibrate
International Patents: | 19 |
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 13 |
NDAs: | 13 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 68 |
Clinical Trials: | 8 |
Patent Applications: | 2,320 |
Formulation / Manufacturing: | see details |
DailyMed Link: | choline fenofibrate at DailyMed |
Recent Clinical Trials for choline fenofibrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Seoul National University Bundang Hospital | Phase 4 |
Daewon Pharmaceutical Co., Ltd. | Phase 4 |
Essentialis, Inc. | Phase 2 |
Pharmacology for choline fenofibrate
Drug Class | Peroxisome Proliferator Receptor alpha Agonist |
Anatomical Therapeutic Chemical (ATC) Classes for choline fenofibrate
Paragraph IV (Patent) Challenges for CHOLINE FENOFIBRATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TRILIPIX | Delayed-release Capsules | choline fenofibrate | 45 mg | 022224 | 1 | 2009-09-02 |
TRILIPIX | Delayed-release Capsules | choline fenofibrate | 135 mg | 022224 | 1 | 2009-09-01 |
US Patents and Regulatory Information for choline fenofibrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alembic | FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 208705-001 | May 12, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Impax Labs Inc | FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 200264-001 | Sep 7, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Abbvie | TRILIPIX | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 022224-001 | Dec 15, 2008 | AB | RX | Yes | No | ⤷ 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 |
International Patents for choline fenofibrate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2010249244 | Formulation comprising fenofibric acid, a physiologically acceptable salt or derivative thereof | ⤷ Try a Trial |
European Patent Office | 1832285 | Formulation comprenant de l'acide fénofibrique ou l'un de ses sels physiologiquement acceptable (Formulation comprising fenofibric acid or a physiologically acceptable salt thereof) | ⤷ Try a Trial |
European Patent Office | 1829541 | Formulation comprenant de l'acide fénofibrique ou l'un de ses sels physiologiquement acceptable (Formulation comprising fenofibric acid or a physiologically acceptable salt thereof) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for choline fenofibrate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1758590 | 300907 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT; REGISTRATION NO/DATE: RVG120593 20170804 |
1746976 | CA 2017 00030 | Denmark | ⤷ Try a Trial | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018 |
1746976 | LUC00026 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL) (MOLECULAR WEIGHT 2000)-OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYL ETHANOLAMINE, E.G. IN THE MOLAR RATIO 3:2:0.015; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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