DrugPatentWatch Database Preview➤ Get the DrugPatentWatch Daily Briefing
« Back to Dashboard
Levothyroxine sodiumis the generic ingredient in eleven branded drugs marketed by Teva Pharms Usa Inc, Institut Biochimique, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Custopharm Inc, Vistapharm, Provell, Cediprof Inc, Genus Lifesciences, Accord Hlthcare, Amneal, Lupin, Merck Kgaa, Mylan, King Pharms, Abbvie, Alvogen, and Stevens J, and is included in twenty-four 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 seventy-two patent family members in twenty-three countries.
There are ten drug master file entries for levothyroxine sodium. Thirty-nine suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for LEVOTHYROXINE SODIUM
|Drug Master File Entries:||10|
|Finished Product Suppliers / Packagers:||39|
|Raw Ingredient (Bulk) Api Vendors:||169|
|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|
|What excipients (inactive ingredients) are in LEVOTHYROXINE SODIUM?||LEVOTHYROXINE SODIUM excipients list|
|DailyMed Link:||LEVOTHYROXINE SODIUM at DailyMed|
Recent Clinical Trials for LEVOTHYROXINE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
|University of California, Los Angeles||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
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
|LEVOTHYROXINE SODIUM||POWDER;INTRAVENOUS||levothyroxine sodium||202231||2015-05-01|
|LEVOTHYROXINE SODIUM||POWDER;INTRAVENOUS||levothyroxine sodium||202231||2015-04-14|
|Country||Patent Number||Estimated Expiration|
|Japan||2005517720||⤷ Free Forever Trial|
|Australia||2002332507||⤷ Free Forever Trial|
|European Patent Office||1365745||⤷ Free Forever Trial|
|Japan||2004525109||⤷ Free Forever Trial|
|Brazil||0207299||⤷ Free Forever Trial|
|Portugal||2683361||⤷ Free Forever Trial|
|Italy||MI20011401||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1291021||132012902104794||Italy||⤷ Free Forever 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|
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.