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Last Updated: August 4, 2020

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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.

Drug Sales Revenue Trends for LEVOTHYROXINE SODIUM

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Recent Clinical Trials for LEVOTHYROXINE SODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Zhejiang Provincial Hospital of TCMPhase 4
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
First People's Hospital of HangzhouPhase 4

See all LEVOTHYROXINE SODIUM clinical trials

Generic filers with tentative approvals for LEVOTHYROXINE SODIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MCG/VIALPOWDER;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 Classl-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

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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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Boehringer Ingelheim
Mallinckrodt
Baxter
Moodys

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