Cholic acid - Generic Drug Details
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What are the generic drug sources for cholic acid and what is the scope of freedom to operate?
Cholic acid
is the generic ingredient in one branded drug marketed by Mirum and is included in one NDA. Additional information is available in the individual branded drug profile pages.There are forty-four drug master file entries for cholic acid. One supplier is listed for this compound.
Summary for cholic acid
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 44 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 111 |
| Clinical Trials: | 10 |
| Patent Applications: | 6,608 |
| What excipients (inactive ingredients) are in cholic acid? | cholic acid excipients list |
| DailyMed Link: | cholic acid at DailyMed |
Recent Clinical Trials for cholic acid
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Brooke Army Medical Center | Phase 3 |
| Ottawa Hospital Research Institute | Phase 3 |
| University of Ottawa | Phase 3 |
Pharmacology for cholic acid
| Drug Class | Bile Acid |
Anatomical Therapeutic Chemical (ATC) Classes for cholic acid
US Patents and Regulatory Information for cholic acid
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mirum | CHOLBAM | cholic acid | CAPSULE;ORAL | 205750-002 | Mar 17, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mirum | CHOLBAM | cholic acid | CAPSULE;ORAL | 205750-001 | Mar 17, 2015 | RX | Yes | 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 |
EU/EMA Drug Approvals for cholic acid
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Theravia | Orphacol | cholic acid | EMEA/H/C/001250 Orphacol is indicated for the treatment of inborn errors in primary bile-acid synthesis due to 3β-hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-oxosteroid-5β-reductase deficiency in infants, children and adolescents aged one month to 18 years and adults. |
Authorised | no | no | no | 2013-09-12 | 2012-05-25 |
| Retrophin Europe Ltd | Kolbam | cholic acid | EMEA/H/C/002081 Cholic Acid FGK is indicated for the treatment of inborn errors of primary bile acid synthesis, in infants from one month of age for continuous lifelong treatment through adulthood, encompassing the following single enzyme defects:sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency;2- (or alpha-) methylacyl-CoA racemase (AMACR) deficiency;cholesterol 7 alpha-hydroxylase (CYP7A1) deficiency. |
Withdrawn | no | no | no | 2015-11-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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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.
ISSN: 2162-2639
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