Tirosint-Sol Generic: When Will Generic Levothyroxine Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Tirosint-Sol Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2026 to 2027 A wide window Why then?
- Has the FDA approved a generic? June 2002 7 companies approved
- When does the last patent end? September 2044 4 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 43 companies list one
It already is. A generic levothyroxine sodium is listed for sale by 43 companies, so ask your pharmacy whether it can fill your prescription with one.
Why 2026 to 2027?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
If Tirosint-Sol’s last patent runs to September 2044, how can a generic come sooner?
The 4 patents that run past the expected month, to September 2044 (10,537,538, 11,096,913, 11,241,382 and 12,564,565), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, a settlement between the companies sets the date. Generic companies have been challenging Tirosint-Sol’s patents with the FDA since September 2022. That is why the expected month comes before the last protection ends. See the road to a generic
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Tirosint-Sol, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Tirosint-Sol by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- $22M a yearSmaller seller
- FDA approved 2016 December 2016 FDA Orange Book
- Patents listed 4 last runs to September 2044 FDA Orange Book
- Generics FDA-approved 7 companies, the first approved June 2002 FDA Orange Book
- Medicare Part D spent $3.9M in 2025, for 3,679 people CMS Part D Spending by Drug
Tirosint-Sol’s Road to a Generic
Tirosint-Sol has had the market to itself since the FDA approved it in December 2016 (Ibsa Institut Biochimique SA). Its 4 listed patents run to September 2044. Generic companies have challenged its patents with the FDA since September 2022.
The first generic of Tirosint-Sol is expected between 2026 and 2027.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before September 2044
The last listed patent runs to September 2044, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Tirosint-Sol Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Tirosint-Sol’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,537,538 | The product’s formulation | February 2037 | Active |
| 11,096,913 | The product’s formulation | February 2037 | Active |
| 11,241,382 | A way of using it (U-3757, U-3758) | September 2039 | Active |
| 12,564,565 | The product’s formulation | September 2044 | Active |
Source: FDA Orange Book, application 206977. Patent numbers open the patent on Google Patents.
Patent Challenges to Tirosint-Sol
The first patent challenge to Tirosint-Sol reached the FDA in September 2022, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Tirosint-Sol’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Oral solution, 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 | September 2022 | 1 company | No decision yet | Not yet | Not yet | February 2037 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Levothyroxine Sodium
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
At least 7 companies have applied to the FDA to make generic levothyroxine sodium.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Tirosint-Sol’s patents with the FDA since September 2022: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 7 companies, the first in June 2002. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic levothyroxine sodium is listed for sale by 43 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Accord Healthcare Inc., American Health Packaging, Amneal Pharmaceuticals NY LLC, Aphena Pharma Solutions - Tennessee, LLC, Ascent Pharmaceuticals, Inc and 34 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Mylan Pharmaceuticals Inc | June 2002 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | AB1,AB2,AB3,AB4 |
| Lupin Inc | January 2019 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | AB1,AB2,AB3 |
| Accord Healthcare Inc | October 2020 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | AB1,AB2,AB3,AB4 |
| Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals USA Inc | May 2022 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | AB1,AB2,AB3,AB4 |
| Macleods Pharmaceuticals Ltd | December 2022 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | AB1,AB2,AB3,AB4 |
| Ascent Pharmaceuticals Inc | January 2023 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | AB4 |
| Alembic Pharmaceuticals Ltd | May 2026 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | AB2 |
| Merck Kgaa discontinued | June 2005 | 0.025MG, 0.05MG, 0.075MG, 0.088MG, 0.1MG, 0.2MG, 0.3MG, 0.15MG, 0.112MG, 0.125MG, 0.175MG | – |
| Amneal Pharmaceuticals LLC discontinued | February 2019 | 0.025MG, 0.05MG, 0.075MG, 0.088MG, 0.1MG, 0.2MG, 0.3MG, 0.15MG, 0.112MG, 0.125MG, 0.137MG, 0.175MG | – |
| Ani Pharmaceuticals Inc discontinued | October 2020 | 0.075MG, 0.088MG, 0.1MG, 0.2MG, 0.15MG, 0.112MG, 0.125MG, 0.137MG, 0.175MG | – |
| Aurobindo Pharma Ltd discontinued | July 2024 | 0.2MG, 0.3MG, 0.15MG, 0.137MG, 0.175MG | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Tirosint-Sol Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Tirosint-Sol, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Tirosint-Sol
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Tirosint-Sol, before manufacturer rebates.
- $987.3K
- January to March 2026, the latest CMS has posted
For 2,441 people, about $228 per prescription fill - $3.9M
- 2025, the whole year
For 3,679 people, about $232 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $987,251 | 2,441 | $228.27 |
| 2025 | $3,876,537 | 3,679 | $231.67 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Tirosint-Sol only, so no generic is counted in it. What CMS says it is used for: Levothyroxine is used to treat an underactive thyroid gland (hypothyroidism). It replaces or provides more thyroid hormone, which is normally produced by the thyroid gland.
Tirosint-Sol Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MCG/ML | Solution | Oral | December 2016 | Prescription reference product |
| 112MCG/ML | Solution | Oral | December 2016 | Prescription reference product |
| 125MCG/ML | Solution | Oral | December 2016 | Prescription reference product |
| 137MCG/ML | Solution | Oral | December 2016 | Prescription reference product |
| 13MCG/ML | Solution | Oral | December 2016 | Prescription reference product |
| 150MCG/ML | Solution | Oral | December 2016 | Prescription reference product |
| 175MCG/ML | Solution | Oral | December 2016 | Prescription reference product |
| 200MCG/ML | Solution | Oral | December 2016 | Prescription reference product |
| 25MCG/ML | Solution | Oral | December 2016 | Prescription reference product |
| 50MCG/ML | Solution | Oral | December 2016 | Prescription reference product |
| 75MCG/ML | Solution | Oral | December 2016 | Prescription reference product |
| 88MCG/ML | Solution | Oral | December 2016 | Prescription reference product |
| 37.5MCG/ML | Solution | Oral | January 2021 | Prescription reference product |
| 44MCG/ML | Solution | Oral | January 2021 | Prescription reference product |
| 62.5MCG/ML | Solution | Oral | January 2021 | Prescription reference product |
Source: FDA Orange Book, Ibsa Institut Biochimique SA.
What a Generic Tirosint-Sol Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Questions people ask about Tirosint-Sol
Is there a generic for Tirosint-Sol right now?
Yes. The FDA NDC Directory lists a generic levothyroxine sodium from 43 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Tirosint-Sol go generic?
It already has. The FDA NDC Directory lists a generic levothyroxine sodium from 43 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic levothyroxine sodium be the same as Tirosint-Sol?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. At least 7 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Tirosint-Sol?
Yes. The FDA Orange Book lists approved generic versions from 7 companies, the first approved in June 2002: Mylan Pharmaceuticals Inc, Lupin Inc, Accord Healthcare Inc, Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals USA Inc and 3 more. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Tirosint-Sol patent expire?
The FDA Orange Book lists 4 patents for Tirosint-Sol; the last runs to September 2044. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (2026 to 2027) weighs all of that.
Has anyone challenged the Tirosint-Sol patents?
Yes. The first patent challenge to Tirosint-Sol reached the FDA in September 2022, from one company on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected 2026 to 2027 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- Duaklir PressairAclidinium Bromide and Formoterol FumarateMarch 2029
- IonsysFentanyl HydrochlorideFebruary 2033
- ViltepsoViltolarsenApril 2034
- AmvuttraVutrisiran SodiumJuly 2036
- NuzolvenceZoliflodacinJanuary 2039
- Selenious AcidSelenious AcidTBD no date yet
About Tirosint-Sol
- Generic name levothyroxine sodium
- How it is taken By mouth
- Company Ibsa Institut Biochimique SA
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since September 2022 (FDA)
- More drugs Brand-name drugs starting with T
- Have a question? A pharmacist answers, free. Ask about Tirosint-Sol
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.