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LEVOTHYROXINE SODIUM Drug Profile
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Which patents cover Levothyroxine Sodium, and when can generic versions of Levothyroxine Sodium launch?
Levothyroxine Sodium is a drug marketed by Teva Pharms Usa Inc, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Accord Hlthcare, Amneal, Lupin, Merck Kgaa, and Mylan. and is included in twelve NDAs. There are five patents protecting this drug and two Paragraph IV challenges.
This drug has four patent family members in three countries.
The generic ingredient in LEVOTHYROXINE SODIUM is levothyroxine sodium. There are ten drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
US ANDA Litigation and Generic Entry Outlook for Levothyroxine Sodium
A generic version of LEVOTHYROXINE SODIUM was approved as levothyroxine sodium by MYLAN on June 5th, 2002.
Summary for LEVOTHYROXINE SODIUM
| International Patents: | 4 |
| US Patents: | 5 |
| Applicants: | 11 |
| NDAs: | 12 |
| Suppliers / Packagers: | 14 |
| Bulk Api Vendors: | 147 |
| Clinical Trials: | 18 |
| Formulation / Manufacturing: | see details |
| Drug Sales Revenues: | Drug sales revenues for LEVOTHYROXINE SODIUM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LEVOTHYROXINE SODIUM |
| DailyMed Link: | LEVOTHYROXINE SODIUM at DailyMed |
Recent Clinical Trials for LEVOTHYROXINE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 4 |
| First People's Hospital of Hangzhou | Phase 4 |
| Zhejiang Provincial Hospital of TCM | Phase 4 |
Pharmacology for LEVOTHYROXINE SODIUM
| Drug Class | l-Thyroxine |
Paragraph IV (Patent) Challenges for LEVOTHYROXINE SODIUM
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TIROSINT | CAPSULE;ORAL | levothyroxine sodium | 021924 | 2019-08-01 |
| TIROSINT | CAPSULE;ORAL | levothyroxine sodium | 021924 | 2017-12-29 |
| LEVOTHYROXINE SODIUM | POWDER;INTRAVENOUS | levothyroxine sodium | 202231 | 2015-05-01 |
| LEVOTHYROXINE SODIUM | POWDER;INTRAVENOUS | levothyroxine sodium | 202231 | 2015-04-14 |
| LEVOXYL | TABLET;ORAL | levothyroxine sodium | 021301 |
US Patents and Regulatory Information for LEVOTHYROXINE SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 076187-001 | Jun 5, 2002 | AB1,AB2,AB3,AB4 | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Amneal | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 210831-005 | Feb 19, 2019 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Accord Hlthcare | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 212399-008 | Oct 19, 2020 | AB2 | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lupin | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 209713-001 | Jan 18, 2019 | AB1,AB2,AB3 | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lupin | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 209713-012 | Jan 18, 2019 | AB1,AB2,AB3 | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Amneal | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 210831-009 | Feb 19, 2019 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Lupin | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 209713-002 | Jan 18, 2019 | AB1,AB2,AB3 | RX | No | 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 |
International Patents for LEVOTHYROXINE SODIUM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013033194 | Start Trial |
| European Patent Office | 2750664 | Start Trial |
| Canada | 3045794 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2018102145 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
