SOTRADECOL Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Sotradecol, and when can generic versions of Sotradecol launch?
Sotradecol is a drug marketed by Elkins Sinn and Mylan Institutional and is included in two NDAs.
The generic ingredient in SOTRADECOL is sodium tetradecyl sulfate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sodium tetradecyl sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sotradecol
A generic version of SOTRADECOL was approved as sodium tetradecyl sulfate by HIKMA on December 9th, 2019.
Summary for SOTRADECOL
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 32 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,251 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | SOTRADECOL at DailyMed |
Recent Clinical Trials for SOTRADECOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Minnesota - Clinical and Translational Science Institute | Phase 1/Phase 2 |
| University of Minnesota | Phase 1/Phase 2 |
| American Rhinologic Society | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for SOTRADECOL
US Patents and Regulatory Information for SOTRADECOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Elkins Sinn | SOTRADECOL | sodium tetradecyl sulfate | INJECTABLE;INJECTION | 005970-004 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan Institutional | SOTRADECOL | sodium tetradecyl sulfate | INJECTABLE;INJECTION | 040541-002 | Nov 12, 2004 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Elkins Sinn | SOTRADECOL | sodium tetradecyl sulfate | INJECTABLE;INJECTION | 005970-005 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan Institutional | SOTRADECOL | sodium tetradecyl sulfate | INJECTABLE;INJECTION | 040541-001 | Nov 12, 2004 | RX | No | 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 |
