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LEVOTHYROXINE SODIUM - Generic Drug Details
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What are the generic sources for levothyroxine sodium and what is the scope of patent protection?
Levothyroxine sodium
is the generic ingredient in ten branded drugs marketed by Institut Biochimique, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Provell, Cediprof Inc, Genus Lifesciences, Amneal Pharms Llc, Lupin Atlantis, Merck Kgaa, Mylan, King Pharms, Abbvie, Alvogen, and Stevens J, and is included in nineteen NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Levothyroxine sodium has sixty-two patent family members in seventeen countries.
There are ten drug master file entries for levothyroxine sodium. Thirty-eight suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for LEVOTHYROXINE SODIUM
| International Patents: | 62 |
| US Patents: | 12 |
| Tradenames: | 10 |
| Applicants: | 17 |
| NDAs: | 19 |
| Drug Master File Entries: | 10 |
| Suppliers / Packagers: | 38 |
| Bulk Api Vendors: | 147 |
| Clinical Trials: | 17 |
| 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 |
|---|---|
| Zhejiang Provincial Hospital of TCM | Phase 4 |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 4 |
| First People's Hospital of Hangzhou | Phase 4 |
Generic filers with tentative approvals for LEVOTHYROXINE SODIUM
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 200MCG/VIAL | POWDER;INTRAVENOUS |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms Llc | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 210831-006 | Feb 19, 2019 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Fresenius Kabi Usa | LEVOTHYROXINE SODIUM | levothyroxine sodium | SOLUTION;INTRAVENOUS | 210632-001 | Apr 11, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Fresenius Kabi Usa | LEVOTHYROXINE SODIUM | levothyroxine sodium | POWDER;INTRAVENOUS | 202231-001 | Jun 24, 2011 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Mylan | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 076187-007 | Jun 5, 2002 | AB1,AB2,AB3,AB4 | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Alvogen | THYRO-TABS | levothyroxine sodium | TABLET;ORAL | 021116-004 | Oct 24, 2002 | AB2,AB4 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LEVOTHYROXINE SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cediprof Inc | LEVO-T | levothyroxine sodium | TABLET;ORAL | 021342-006 | Mar 1, 2002 | Start Trial | Start Trial |
| Cediprof Inc | LEVO-T | levothyroxine sodium | TABLET;ORAL | 021342-001 | Mar 1, 2002 | Start Trial | Start Trial |
| Cediprof Inc | LEVO-T | levothyroxine sodium | TABLET;ORAL | 021342-003 | Mar 1, 2002 | Start Trial | Start Trial |
| Cediprof Inc | LEVO-T | levothyroxine sodium | TABLET;ORAL | 021342-005 | Mar 1, 2002 | Start Trial | Start Trial |
| Cediprof Inc | LEVO-T | levothyroxine sodium | TABLET;ORAL | 021342-011 | Mar 1, 2002 | Start Trial | Start Trial |
| Cediprof Inc | LEVO-T | levothyroxine sodium | TABLET;ORAL | 021342-010 | Mar 1, 2002 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LEVOTHYROXINE SODIUM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2438907 | Start Trial |
| Canada | 2392545 | Start Trial |
| Spain | 2334777 | Start Trial |
| European Patent Office | 1365745 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2013033194 | Start Trial |
| Denmark | 1291021 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LEVOTHYROXINE SODIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1291021 | 132012902104794 | Italy | Start Trial | PRODUCT NAME: LEVOTIROXINA SODICA(ALIASINT); AUTHORISATION NUMBER(S) AND DATE(S): RVG 106848; 106850-106860, 20110407;DA 041528011/M A 041528365/M, 20120808 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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