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 Travere 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: | 98 |
| 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 Colorado, Denver | Phase 1/Phase 2 |
| University of Nebraska | Phase 1/Phase 2 |
| Children's Hospital Medical Center, Cincinnati | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for CHOLBAM
US Patents and Regulatory Information for CHOLBAM
CHOLBAM is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting CHOLBAM
TREATMENT OF BILE ACID SYNTHESIS DISORDERS DUE TO SINGLE ENZYME DEFECTS
Exclusivity Expiration: See Plans and Pricing
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Travere | CHOLBAM | cholic acid | CAPSULE;ORAL | 205750-001 | Mar 17, 2015 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Travere | CHOLBAM | cholic acid | CAPSULE;ORAL | 205750-002 | Mar 17, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
