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TIROSINT-SOL Drug Profile
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» See Plans and PricingWhich patents cover Tirosint-sol, and when can generic versions of Tirosint-sol launch?
Tirosint-sol is a drug marketed by Institut Biochimique and is included in one NDA. There is one patent protecting this drug.
This drug has five patent family members in four countries.
The generic ingredient in TIROSINT-SOL is levothyroxine sodium. There are ten drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
US ANDA Litigation and Generic Entry Outlook for Tirosint-sol
A generic version of TIROSINT-SOL was approved as levothyroxine sodium by MYLAN on June 5th, 2002.
Summary for TIROSINT-SOL
| International Patents: | 5 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 53 |
| Clinical Trials: | 4 |
| Patent Applications: | 1,634 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TIROSINT-SOL |
| DailyMed Link: | TIROSINT-SOL at DailyMed |
Recent Clinical Trials for TIROSINT-SOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| IBSA Institut Biochimique SA | Phase 4 |
| Meyer Children's Hospital | Phase 4 |
| University of Colorado, Denver | N/A |
US Patents and Regulatory Information for TIROSINT-SOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Institut Biochimique | TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977-001 | Dec 15, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Institut Biochimique | TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977-007 | Dec 15, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Institut Biochimique | TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977-004 | Dec 15, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for TIROSINT-SOL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3311844 | Start Trial |
| China | 109789213 | Start Trial |
| European Patent Office | 3528847 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
