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.
Summary for LEVOTHYROXINE SODIUM
International Patents: | 74 |
US Patents: | 17 |
Tradenames: | 12 |
Applicants: | 22 |
NDAs: | 26 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 39 |
Raw Ingredient (Bulk) Api Vendors: | 165 |
Clinical Trials: | 22 |
Patent Applications: | 6,539 |
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 |
---|---|
Cromsource | Phase 4 |
University of California, Los Angeles | Phase 4 |
First People's Hospital of Hangzhou | Phase 4 |
Generic filers with tentative approvals for LEVOTHYROXINE SODIUM
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 200MCG/VIAL | POWDER;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 |
International Patents for LEVOTHYROXINE SODIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3528847 | SOLUTIONS CONDITIONNÉES À STABILITÉ ÉLEVÉE D'HORMONE THYROÏDIENNE T4 (HIGH-STABILITY PACKAGED SOLUTIONS OF T4 THYROID HORMONE) | See Plans and Pricing |
Poland | 3528847 | See Plans and Pricing | |
Cyprus | 1117151 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated 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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