CHOLBAM Drug Patent Profile
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When do Cholbam patents expire, and when can generic versions of Cholbam launch?
Cholbam is a drug marketed by Mirum and is included in one NDA.
The generic ingredient in CHOLBAM is cholic acid. There are forty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cholic acid profile page.
Summary for CHOLBAM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 111 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CHOLBAM |
| What excipients (inactive ingredients) are in CHOLBAM? | CHOLBAM excipients list |
| DailyMed Link: | CHOLBAM at DailyMed |
Recent Clinical Trials for CHOLBAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Nebraska | Phase 1/Phase 2 |
| Children's Hospital Medical Center, Cincinnati | Phase 1/Phase 2 |
| University of Pittsburgh | Phase 1/Phase 2 |
Pharmacology for CHOLBAM
| Drug Class | Bile Acid |
Anatomical Therapeutic Chemical (ATC) Classes for CHOLBAM
US Patents and Regulatory Information for CHOLBAM
| 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 | 205750-001 | Mar 17, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mirum | CHOLBAM | cholic acid | CAPSULE;ORAL | 205750-002 | Mar 17, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
EU/EMA Drug Approvals for CHOLBAM
| 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 |
