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Last Updated: June 24, 2022

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 twelve 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, Mylan, Vistapharm, Provell, Cediprof Inc, Genus Lifesciences, Accord Hlthcare, Amneal, Lupin, Merck Kgaa, Watson Labs Teva, King Pharms, Abbvie, Alvogen, and Stevens J, and is included in twenty-six NDAs. There are seventeen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Levothyroxine sodium has seventy-four 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.

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
CromsourcePhase 4
University of California, Los AngelesPhase 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
See Plans and PricingSee Plans and Pricing200MCG/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 Class l-Thyroxine
Paragraph IV (Patent) Challenges for LEVOTHYROXINE SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TIROSINT Capsules levothyroxine sodium 200 mcg 021924 1 2021-12-30
TIROSINT Capsules levothyroxine sodium 112 mcg 021924 1 2020-12-18
TIROSINT Capsules levothyroxine sodium 88 mcg, 100 mcg and 125 mcg 021924 1 2019-08-01
TIROSINT Capsules levothyroxine sodium 75 mcg and 150 mcg 021924 1 2017-12-29
LEVOTHYROXINE SODIUM for Injection levothyroxine sodium 200 mcg/vial 202231 1 2015-05-01
LEVOTHYROXINE SODIUM for Injection levothyroxine sodium 100 mcg/vial and 500 mcg/vial 202231 2 2015-04-14

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 076187-011 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187-003 Jun 5, 2002 AB1,AB2,AB3,AB4 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Institut Biochimique TIROSINT levothyroxine sodium CAPSULE;ORAL 021924-013 Aug 1, 2007 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 021342-004 Mar 1, 2002 See Plans and Pricing See Plans and Pricing
King Pharms LEVOXYL levothyroxine sodium TABLET;ORAL 021301-007 May 25, 2001 See Plans and Pricing See Plans and Pricing
King Pharms LEVOXYL levothyroxine sodium TABLET;ORAL 021301-006 May 25, 2001 See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing 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:

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McKesson
Boehringer Ingelheim
Mallinckrodt
Baxter
Moodys

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