LEVOTHYROXINE SODIUM Drug Patent 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, Zydus Pharms, Hikma, Accord Hlthcare, Amneal, Ascent Pharms Inc, Lupin, Macleods Pharms Ltd, Merck Kgaa, Mylan, and Watson Labs Teva. and is included in eighteen NDAs. There are seven patents protecting this drug and two Paragraph IV challenges.
This drug has five 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. Forty-eight suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
DrugPatentWatch® 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: | 5 |
US Patents: | 7 |
Applicants: | 16 |
NDAs: | 18 |
Finished Product Suppliers / Packagers: | 32 |
Raw Ingredient (Bulk) Api Vendors: | 190 |
Clinical Trials: | 25 |
Patent Applications: | 3,918 |
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
Sponsor | Phase |
---|---|
University of Pennsylvania | Phase 4 |
National Institute on Aging (NIA) | Phase 4 |
Xeris Pharmaceuticals | Phase 2 |
Pharmacology for LEVOTHYROXINE SODIUM
Drug Class | l-Thyroxine |
Anatomical Therapeutic Chemical (ATC) Classes for LEVOTHYROXINE SODIUM
Paragraph IV (Patent) Challenges for LEVOTHYROXINE SODIUM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
THYQUIDITY | Oral Solution | levothyroxine sodium | 100 mcg/5 mL | 214047 | 1 | 2022-12-28 |
TIROSINT | Capsules | levothyroxine sodium | 137 mcg and 175 mcg | 021924 | 1 | 2022-11-04 |
TIROSINT-SOL | Oral Solution | levothyroxine sodium | 13 mcg/mL 25 mcg/mL 50 mcg/mL 75 mcg/mL 88 mcg/mL 100 mcg/mL 112 mcg/mL 125 mcg/mL 137 mcg/mL 150 mcg/mL 175 mcg/mL 200 mcg/mL | 206977 | 1 | 2022-09-30 |
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
LEVOTHYROXINE SODIUM is protected by seven US patents.
Patents protecting LEVOTHYROXINE SODIUM
Levothyroxine liquid formulations
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Levothyroxine liquid formulations
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Stabilized liquid formulation of levothyroxine
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Levothyroxine formulations
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Levothyroxine formulations
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Levothyroxine formulations
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Levothyroxine liquid formulations
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Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Ascent Pharms Inc | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 215259-010 | Jan 18, 2023 | AB4 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Merck Kgaa | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 076752-003 | Jun 16, 2005 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Accord Hlthcare | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 212399-003 | Oct 19, 2020 | AB1,AB2,AB3,AB4 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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
See the table below for patents covering LEVOTHYROXINE SODIUM around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 3045794 | FORMULATIONS LIQUIDES DE LEVOTHYROXINE (LEVOTHYROXINE LIQUID FORMULATIONS) | ⤷ Sign Up |
European Patent Office | 2750664 | FORMULATIONS DE LÉVOTHYROXINE (LEVOTHYROXINE FORMULATIONS) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2017013591 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |