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, Endo Operations, Fresenius Kabi Usa, Maia Pharms Inc, Piramal Critical, Zydus Pharms, Hikma, Accord Hlthcare, Amneal, Ascent Pharms Inc, Aurobindo Pharma, Lupin, Macleods Pharms Ltd, Merck Kgaa, Mylan, and Watson Labs Teva. and is included in nineteen 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. Fifty-one 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.
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Summary for LEVOTHYROXINE SODIUM
| International Patents: | 5 |
| US Patents: | 7 |
| Applicants: | 17 |
| NDAs: | 19 |
| Finished Product Suppliers / Packagers: | 36 |
| Raw Ingredient (Bulk) Api Vendors: | 190 |
| Clinical Trials: | 25 |
| Patent Applications: | 4,157 |
| 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 |
|---|---|
| National Institute on Aging (NIA) | Phase 4 |
| University of Pennsylvania | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ascent Pharms Inc | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 215259-010 | Jan 18, 2023 | AB4 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Macleods Pharms Ltd | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 211417-010 | Dec 21, 2022 | AB1,AB2 | RX | 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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2018102145 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2013033194 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2017013591 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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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