ACTIGALL Drug Patent Profile
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Which patents cover Actigall, and when can generic versions of Actigall launch?
Actigall is a drug marketed by Teva Branded Pharm and is included in one NDA.
The generic ingredient in ACTIGALL is ursodiol. There are eight drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Actigall
A generic version of ACTIGALL was approved as ursodiol by EPIC PHARMA on March 14th, 2000.
Summary for ACTIGALL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Clinical Trials: | 6 |
| Patent Applications: | 4,741 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ACTIGALL |
| What excipients (inactive ingredients) are in ACTIGALL? | ACTIGALL excipients list |
| DailyMed Link: | ACTIGALL at DailyMed |
Recent Clinical Trials for ACTIGALL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The University of Texas Health Science Center at San Antonio | Phase 2 |
| Children's Hospital of Philadelphia | Phase 1 |
| University of Tennessee | Phase 1 |
US Patents and Regulatory Information for ACTIGALL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | ACTIGALL | ursodiol | CAPSULE;ORAL | 019594-001 | Dec 31, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Teva Branded Pharm | ACTIGALL | ursodiol | CAPSULE;ORAL | 019594-002 | Dec 31, 1987 | AB | 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 |
