Cholestyramine - Generic Drug Details
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What are the generic sources for cholestyramine and what is the scope of freedom to operate?
Cholestyramine
is the generic ingredient in eight branded drugs marketed by Parke Davis, Ajanta Pharma Ltd, Alkem Labs Ltd, Ani Pharms, Endo Operations, Epic Pharma Llc, Ivax Sub Teva Pharms, Tagi, Teva, Upsher Smith Labs, Zydus Pharms, Teva Pharms, Chartwell Rx, Bristol Myers, and Apothecon, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for cholestyramine. Fourteen suppliers are listed for this compound.
Summary for cholestyramine
US Patents: | 0 |
Tradenames: | 8 |
Applicants: | 15 |
NDAs: | 25 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 39 |
Drug Prices: | Drug price trends for cholestyramine |
What excipients (inactive ingredients) are in cholestyramine? | cholestyramine excipients list |
DailyMed Link: | cholestyramine at DailyMed |
Recent Clinical Trials for cholestyramine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Centre Hospitalier Universitaire de Nice | N/A |
Loxo Oncology, Inc. | Phase 1 |
Eli Lilly and Company | Phase 1 |
Pharmacology for cholestyramine
Drug Class | Bile Acid Sequestrant |
Mechanism of Action | Bile-acid Binding Activity |
US Patents and Regulatory Information for cholestyramine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Endo Operations | CHOLESTYRAMINE | cholestyramine | POWDER;ORAL | 077204-002 | Aug 26, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bristol Myers | QUESTRAN LIGHT | cholestyramine | POWDER;ORAL | 019669-001 | Dec 5, 1988 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bristol Myers | QUESTRAN | cholestyramine | POWDER;ORAL | 016640-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Endo Operations | CHOLESTYRAMINE | cholestyramine | POWDER;ORAL | 077204-001 | Aug 26, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bristol Myers | QUESTRAN LIGHT | cholestyramine | POWDER;ORAL | 019669-003 | Dec 5, 1988 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Alkem Labs Ltd | CHOLESTYRAMINE | cholestyramine | POWDER;ORAL | 211856-002 | Oct 19, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ani Pharms | CHOLESTYRAMINE | cholestyramine | POWDER;ORAL | 074554-002 | Oct 2, 1996 | DISCN | 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 cholestyramine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Parke Davis | CHOLYBAR | cholestyramine | BAR, CHEWABLE;ORAL | 071621-001 | May 26, 1988 | ⤷ Sign Up | ⤷ Sign Up |
Parke Davis | CHOLYBAR | cholestyramine | BAR, CHEWABLE;ORAL | 071739-001 | May 26, 1988 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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