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CHOLBAM Drug Profile
» See Plans and Pricing
When do Cholbam patents expire, and when can generic versions of Cholbam launch?
Cholbam is a drug marketed by Rtrx 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 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 81 |
| Clinical Trials: | 1 |
| Patent Applications: | 6,113 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CHOLBAM |
| DailyMed Link: | CHOLBAM at DailyMed |
Generic Entry Opportunity Date for CHOLBAM
Generic Entry Date for CHOLBAM*:
Constraining patent/regulatory exclusivity:
TREATMENT OF BILE ACID SYNTHESIS DISORDERS DUE TO SINGLE ENZYME DEFECTS NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for CHOLBAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Pittsburgh | Phase 1/Phase 2 |
| Children's Hospital Medical Center, Cincinnati | Phase 1/Phase 2 |
| University of Nebraska | Phase 1/Phase 2 |
Pharmacology for CHOLBAM
| Drug Class | Bile Acid |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rtrx | CHOLBAM | cholic acid | CAPSULE;ORAL | 205750-001 | Mar 17, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Rtrx | CHOLBAM | cholic acid | CAPSULE;ORAL | 205750-002 | Mar 17, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Rtrx | CHOLBAM | cholic acid | CAPSULE;ORAL | 205750-001 | Mar 17, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
