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Levothyroxine Sodium Patent Expiration

Levothyroxine Sodium was first introduced by Jerome Stevens Pharmaceuticals Inc in its drug Unithroid on Aug 21, 2000. Other drugs containing Levothyroxine Sodium are Thyro-Tabs, Thyquidity, Levoxyl, Euthyrox, Tirosint, Ermeza, Levothyroxine Sodium, Levo-T, Synthroid, Levolet, Tirosint-Sol. 29 different companies have introduced drugs containing Levothyroxine Sodium.


Levothyroxine Sodium Patents

Given below is the list of patents protecting Levothyroxine Sodium, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Tirosint-sol US11241382 Administration regimen of compositions of T4 thyroid hormone with high oral absorption Sep 17, 2039 Ibsa
Levolet US10231931 Thyroid hormone oral dosage forms and methods of using the same Mar 23, 2038 Genus Lifesciences
Levolet US10406108 Thyroid hormone oral dosage forms and methods of using the same Mar 23, 2038 Genus Lifesciences
Tirosint-sol US10537538 High-stability packaged solutions of T4 thyroid hormone Feb 28, 2037 Ibsa
Tirosint-sol US11096913 High-stability packaged solutions of T4 thyroid hormone Feb 28, 2037 Ibsa
Levothyroxine Sodium US10398669 Levothyroxine liquid formulations Dec 01, 2036 Fresenius Kabi Usa
Levothyroxine Sodium US11135190 Levothyroxine liquid formulations Dec 01, 2036 Fresenius Kabi Usa
Levothyroxine Sodium US9782376 Levothyroxine liquid formulations Dec 01, 2036 Fresenius Kabi Usa
Levothyroxine Sodium US11154498 Stabilized liquid formulation of levothyroxine Jul 20, 2036 Hikma
Ermeza US9345772 Liquid levothyroxine formulations Feb 27, 2035 Mylan
Levothyroxine Sodium US9006289 Levothyroxine formulations Oct 03, 2032 Fresenius Kabi Usa
Levothyroxine Sodium US9168238 Levothyroxine formulations Aug 29, 2032 Fresenius Kabi Usa
Levothyroxine Sodium US9168239 Levothyroxine formulations Aug 29, 2032 Fresenius Kabi Usa
Thyquidity US9050307 Method for the preparation of a levothyroxine solution Aug 06, 2031 Azurity
Tirosint US7691411 Pharmaceutical formulae for thyroid hormones and procedures for obtaining them Mar 14, 2024

(Expired)

 Ibsa
Tirosint US7723390 Pharmaceutical formulations for thyroid hormones Mar 14, 2024

(Expired)

 Ibsa
Tirosint US7723390 Pharmaceutical formulations for thyroid hormones Mar 14, 2024

(Expired)

 Inst Biochimique
Levoxyl US7101569 Methods of administering levothyroxine pharmaceutical compositions Oct 02, 2023

(Expired)

 King Pharms
Levoxyl US6555581 Levothyroxine compositions and methods Feb 15, 2022

(Expired)

 King Pharms
Levoxyl US7067148 Stabilized pharmaceutical and thyroid hormone compositions and method of preparation Feb 15, 2022

(Expired)

 King Pharms
Levo-t US6399101 Stable thyroid hormone preparations and method of making same Mar 30, 2020

(Expired)

 Cediprof Inc



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Levothyroxine Sodium's patents.

Given below is the list recent legal activities going on the following patents of Levothyroxine Sodium.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 20 Jun, 2023 US10537538
Payment of Maintenance Fee, 8th Year, Large Entity 27 Apr, 2023 US9168238
Payment of Maintenance Fee, 8th Year, Large Entity 27 Apr, 2023 US9168239
Payment of Maintenance Fee, 4th Year, Large Entity 03 Mar, 2023 US10398669
Payment of Maintenance Fee, 8th Yr, Small Entity 07 Dec, 2022 US9050307
Change in Power of Attorney (May Include Associate POA)
Critical
 01 Dec, 2022 US9168238
Email Notification
Critical
 01 Dec, 2022 US9168239
Change in Power of Attorney (May Include Associate POA)
Critical
 01 Dec, 2022 US9168239
Email Notification
Critical
 01 Dec, 2022 US9168238
Correspondence Address Change
Critical
 21 Nov, 2022 US9168238


Levothyroxine Sodium's Family Patents

Family Patents

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Levothyroxine Sodium Generic API Manufacturers

Several generic applications have been filed for Levothyroxine Sodium. The first generic version for Levothyroxine Sodium was by Mylan Pharmaceuticals Inc and was approved on Jun 5, 2002. And the latest generic version is by Steriscience Pte Ltd and was approved on Mar 5, 2025.

Given below is the list of companies who have filed for Levothyroxine Sodium generic, along with the locations of their manufacturing plants worldwide.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 12 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Oct 19, 2020
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Oct 19, 2020
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Oct 19, 2020
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Oct 19, 2020
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Oct 19, 2020
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Oct 19, 2020
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Oct 19, 2020
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Oct 19, 2020
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Oct 19, 2020
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Oct 19, 2020
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Oct 19, 2020
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Oct 19, 2020





2. AMNEAL

Amneal Pharmaceuticals Llc has filed for 12 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.112MG

tablet Discontinued ORAL N/A Feb 19, 2019
0.025MG

tablet Discontinued ORAL N/A Feb 19, 2019
0.05MG

tablet Discontinued ORAL N/A Feb 19, 2019
0.075MG

tablet Discontinued ORAL N/A Feb 19, 2019
0.088MG

tablet Discontinued ORAL N/A Feb 19, 2019
0.1MG

tablet Discontinued ORAL N/A Feb 19, 2019
0.125MG

tablet Discontinued ORAL N/A Feb 19, 2019
0.137MG

tablet Discontinued ORAL N/A Feb 19, 2019
0.15MG

tablet Discontinued ORAL N/A Feb 19, 2019
0.175MG

tablet Discontinued ORAL N/A Feb 19, 2019
0.2MG

tablet Discontinued ORAL N/A Feb 19, 2019
0.3MG

tablet Discontinued ORAL N/A Feb 19, 2019


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Branchburg Amneal Pharmaceuticals, LLC
Piscataway Amneal Pharmaceuticals, LLC
Bridgewater Amneal Complex Products Research LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Hyderabad Amneal Oncology Private Limited





3. ASCENT PHARMS INC

Ascent Pharmaceuticals Inc has filed for 12 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Ascent Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB4 Jan 18, 2023
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB4 Jan 18, 2023
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB4 Jan 18, 2023
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB4 Jan 18, 2023
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB4 Jan 18, 2023
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB4 Jan 18, 2023
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB4 Jan 18, 2023
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB4 Jan 18, 2023
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB4 Jan 18, 2023
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB4 Jan 18, 2023
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB4 Jan 18, 2023
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB4 Jan 18, 2023





4. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 5 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG

tablet Discontinued ORAL N/A Jul 16, 2024
0.15MG

tablet Discontinued ORAL N/A Jul 16, 2024
0.137MG

tablet Discontinued ORAL N/A Jul 16, 2024
0.3MG

tablet Discontinued ORAL N/A Jul 16, 2024
0.175MG

tablet Discontinued ORAL N/A Jul 16, 2024


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Sangareddy Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





5. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MCG/VIAL

powder Discontinued INTRAVENOUS N/A Mar 27, 2020





6. ENDO OPERATIONS

Endo Operations Ltd has filed for 1 generic for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MCG/VIAL

powder Discontinued INTRAVENOUS N/A Dec 7, 2015





7. LUPIN

Lupin Inc has filed for 12 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Lupin.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3 Jan 18, 2019
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3 Jan 18, 2019
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3 Jan 18, 2019
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3 Jan 18, 2019
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3 Jan 18, 2019
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3 Jan 18, 2019
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3 Jan 18, 2019
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3 Jan 18, 2019
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3 Jan 18, 2019
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3 Jan 18, 2019
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3 Jan 18, 2019
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3 Jan 18, 2019


Manufacturing Plant Locations
New

Lupin's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Lupin as present at those locations.

Country City Firm Name
India
Mandideep Lupin Limited (Unit II)
Tarapur, Thane Lupin Limited
Pirangut Lupin Limited
Pithampur Lupin Limited
Anakapalli District Lupin Manufacturing Solutions Limited
Pune Lupin Bioresearch Center
Pithampur Lupin Limited (Unit 1)
Aurangabad Lupin Ltd.
Mandideep Lupin Limited
Navi Mumbai LUPIN LIMITED
Dabhasa LUPIN MANUFACTURING SOLUTIONS LIMITED
Mumbai Lupin Limited
Vasco Da Gama Lupin Limited
Nagpur Lupin Limited
United States
Baltimore Lupin Pharmaceuticals Inc.
Coral Springs Lupin Research Inc





8. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 12 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Dec 21, 2022
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Dec 21, 2022
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Dec 21, 2022
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Dec 21, 2022
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Dec 21, 2022
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Dec 21, 2022
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Dec 21, 2022
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Dec 21, 2022
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Dec 21, 2022
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Dec 21, 2022
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Dec 21, 2022
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Dec 21, 2022





9. MAIA PHARMS INC

Maia Pharmaceuticals Inc has filed for 3 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Maia Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MCG/VIAL

powder Prescription INTRAVENOUS AP Dec 21, 2018
500MCG/VIAL

powder Prescription INTRAVENOUS AP Dec 21, 2018
200MCG/VIAL

powder Prescription INTRAVENOUS AP Dec 21, 2018





10. MERCK KGAA

Merck Kgaa has filed for 11 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Merck Kgaa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.112MG

tablet Discontinued ORAL N/A Jun 16, 2005
0.3MG

tablet Discontinued ORAL N/A Jun 16, 2005
0.2MG

tablet Discontinued ORAL N/A Jun 16, 2005
0.175MG

tablet Discontinued ORAL N/A Jun 16, 2005
0.088MG

tablet Discontinued ORAL N/A Jun 16, 2005
0.1MG

tablet Discontinued ORAL N/A Jun 16, 2005
0.15MG

tablet Discontinued ORAL N/A Jun 16, 2005
0.125MG

tablet Discontinued ORAL N/A Jun 16, 2005
0.025MG

tablet Discontinued ORAL N/A Jun 16, 2005
0.05MG

tablet Discontinued ORAL N/A Jun 16, 2005
0.075MG

tablet Discontinued ORAL N/A Jun 16, 2005


Manufacturing Plant Locations
New

Merck Kgaa's manufacturing plants are situated in 1 country - Germany. Given below are the details of these plant locations as well as the firm names of Merck Kgaa as present at those locations.

Country City Firm Name
Germany
Darmstadt Merck KGaA





11. MYLAN

Mylan Pharmaceuticals Inc has filed for 12 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Jun 5, 2002
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Jun 5, 2002
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

(reference standard)

tablet Prescription ORAL AB1,AB2,AB3,AB4 Jun 5, 2002
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Jun 5, 2002
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Jun 5, 2002
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Jun 5, 2002
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Jun 5, 2002
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Jun 5, 2002
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Jun 5, 2002
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Jun 5, 2002
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Jun 5, 2002
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 Dec 13, 2006


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Saint Albans Mylan Technologies, Inc.
Greensboro Mylan Pharmaceuticals Inc
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Morgantown Mylan Specialty, L.P.
Rockford Mylan Institutional, Inc.
San Carlos Mylan Pharmaceuticals Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
India
Bangalore Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Hyderabad Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





12. PIRAMAL CRITICAL

Piramal Critical Care Ltd has filed for 2 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Piramal Critical.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MCG/VIAL

powder Prescription INTRAVENOUS AP Jun 29, 2016
500MCG/VIAL

powder Prescription INTRAVENOUS AP Jun 29, 2016


Manufacturing Plant Locations
New

Piramal Critical's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Piramal Critical as present at those locations.

Country City Firm Name
United States
Bethlehem Piramal Critical Care, Inc.





13. STERISCIENCE

Steriscience Pte Ltd has filed for 3 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Steriscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MCG/VIAL

powder Prescription INTRAVENOUS AP Mar 5, 2025
200MCG/VIAL

powder Prescription INTRAVENOUS AP Mar 5, 2025
100MCG/VIAL

powder Prescription INTRAVENOUS AP Mar 5, 2025


Manufacturing Plant Locations
New

Steriscience's manufacturing plants are situated in 2 countries - India, Poland. Given below are the details of these plant locations as well as the firm names of Steriscience as present at those locations.

Country City Firm Name
India
Bengaluru Steriscience Specialties Private Limited
Poland
Warsaw Steriscience SP. Z O.O.





14. TEVA PHARMS USA INC

Teva Pharmaceuticals Usa Inc has filed for 9 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.075MG

capsule Discontinued ORAL N/A Oct 28, 2020
0.15MG

capsule Discontinued ORAL N/A Oct 28, 2020
0.1MG

capsule Discontinued ORAL N/A Jan 6, 2021
0.088MG

capsule Discontinued ORAL N/A Jan 6, 2021
0.125MG

capsule Discontinued ORAL N/A Jan 6, 2021
0.112MG

capsule Discontinued ORAL N/A Apr 16, 2021
0.2MG

capsule Discontinued ORAL N/A Nov 9, 2022
0.175MG

capsule Discontinued ORAL N/A May 2, 2023
0.137MG

capsule Discontinued ORAL N/A May 2, 2023





15. WATSON LABS TEVA

Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 12 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Watson Labs Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 May 10, 2022
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 May 10, 2022
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 May 10, 2022
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 May 10, 2022
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 May 10, 2022
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 May 10, 2022
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 May 10, 2022
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 May 10, 2022
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 May 10, 2022
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 May 10, 2022
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 May 10, 2022
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

tablet Prescription ORAL AB1,AB2,AB3,AB4 May 10, 2022





16. XIROMED

Xiromed Pharma Espana Sl has filed for 1 generic for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Xiromed.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MCG/VIAL

powder Prescription INTRAVENOUS AP Nov 29, 2024


Manufacturing Plant Locations
New

Xiromed's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Xiromed as present at those locations.

Country City Firm Name
United States
Florham Park XIROMED LLC





17. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Levothyroxine Sodium. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MCG/VIAL

powder Prescription INTRAVENOUS AP Mar 24, 2023
500MCG/VIAL

powder Prescription INTRAVENOUS AP Mar 24, 2023
200MCG/VIAL

powder Prescription INTRAVENOUS AP Mar 24, 2023