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Generated: July 23, 2017
What is the patent landscape for Levothyroxine Sodium, and what generic Levothyroxine Sodium alternatives are available?
Levothyroxine Sodium is a drug marketed by Fresenius Kabi Usa, Merck Kgaa, Fera Pharms Llc, Par Sterile Products, and Mylan. and is included in five NDAs. There are three patents protecting this drug and two Paragraph IV challenges.| Patents: | 3 |
| Applicants: | 5 |
| NDAs: | 5 |
| Suppliers / Packagers: see list | 10 |
| Bulk Api Vendors: see list | 114 |
| Clinical Trials: see list | 2,406 |
| Patent Applications: see list | 6,779 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | LEVOTHYROXINE SODIUM at DailyMed |
| Ingredient-type | Thyroxine |
| Drug Class | l-Thyroxine |
| 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 | 076187-008 | Jun 5, 2002 | AB1,AB2,AB3,AB4 | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mylan | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 076187-005 | Jun 5, 2002 | AB1,AB2,AB3,AB4 | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mylan | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 076187-009 | Jun 5, 2002 | AB1,AB2,AB3,AB4 | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mylan | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 076187-006 | Jun 5, 2002 | AB1,AB2,AB3,AB4 | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Fresenius Kabi Usa | LEVOTHYROXINE SODIUM | levothyroxine sodium | POWDER;INTRAVENOUS | 202231-001 | Jun 24, 2011 | AP | RX | Yes | Yes | 9,006,289 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| levothyroxine sodium | for Injection | 100 mcg/vial and 500 mcg/vial | Levothyroxine Sodium | 4/14/2015 |
| levothyroxine sodium | for Injection | 200 mcg/vial | Levothyroxine Sodium | 5/1/2015 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013033194 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2750664 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving 500+ 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 verifification 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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