Tosymra Generic: When Will Generic Sumatriptan 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
Tosymra Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July 2031 About 5 years away Why then?
- Has the FDA approved a generic? February 2016 4 companies approved
- When does the last patent end? July 2031 9 patents listed with the FDA
- Can you buy a generic today? Yes 6 companies list one
It already is. A generic sumatriptan is listed for sale by 6 companies, so ask your pharmacy whether it can fill your prescription with one.
Why July 2031?
It is when Tosymra’s patent 9,211,282 ends. That patent covers the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Tosymra, 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.
Tosymra by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- $4M a yearSmaller seller
- FDA approved 2019 January 2019 FDA Orange Book
- Patents listed 9 last runs to July 2031 FDA Orange Book
- Generics FDA-approved 4 companies, the first approved February 2016 FDA Orange Book
- Pharmacies pay $108.22 each NADAC, October 2026
- Medicare Part D spent $415.6K in 2025, for 163 people CMS Part D Spending by Drug
- Medicaid prescriptions 359 in the last four reported quarters, $242.3K CMS Medicaid drug utilization, to Q1 2026
Tosymra’s Road to a Generic
Tosymra has had the market to itself since the FDA approved it in January 2019 (Tonix Medicines Inc). Its 9 listed patents run to July 2031 (3 already expired).
The first generic of Tosymra is expected in July 2031.
Why that month: patent 9,211,282, on the product’s formulation and a way of using it, ends then.
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.
Tosymra Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Tosymra’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.
The one that matters for a generic launch: patent 9,211,282, which ends in July 2031, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,268,791 | The product’s formulation | May 2026 | Expired |
| 8,440,631 | The product’s formulation; a way of using it (U-1719) | May 2026 | Expired |
| 9,283,280 | The product’s formulation | May 2026 | Expired |
| 9,610,280 | The product’s formulation; a way of using it (U-1719) | June 2030 | Active |
| 9,974,770 | The product’s formulation; a way of using it (U-1719) | June 2030 | Active |
| 10,603,305 | The product’s formulation; a way of using it (U-1719) | June 2030 | Active |
| 11,337,962 | The product’s formulation; a way of using it (U-1719) | June 2030 | Active |
| 12,090,139 | The product’s formulation | June 2030 | Active |
| 9,211,282 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-1719) | July 2031 | Active |
Source: FDA Orange Book, application 210884. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Sumatriptan
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
No application count is on record for Tosymra, but the FDA has already approved 4 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 4 companies, the first in February 2016. 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 sumatriptan is listed for sale by 6 companies. Ask your pharmacy whether it can fill your prescription with it.
Bryant Ranch Prepack, Cipla USA Inc., Florida Pharmaceutical Products, LLC., Lannett Company, Inc., Padagis Israel Pharmaceuticals Ltd and Prasco Laboratories
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Lannett Co Inc | February 2016 | 5MG/SPRAY, 20MG/SPRAY | AB |
| Padagis Israel Pharmaceuticals Ltd | September 2020 | 5MG/SPRAY, 20MG/SPRAY | AB |
| Regcon Holdings LLC | February 2021 | 20MG/SPRAY | AB |
| Cipla Ltd | February 2021 | 20MG/SPRAY | AB |
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).
Tosymra Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Tosymra 10 mg nasal spray
$108.22 each in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid each |
|---|---|
| October 2026 | $108.22 |
| September 2026 | $108.22 |
| August 2026 | $108.22 |
| July 2026 | $108.18 |
| June 2026 | $108.18 |
| May 2026 | $108.15 |
| April 2026 | $108.15 |
| March 2026 | $107.93 |
| February 2026 | $107.82 |
| January 2026 | $107.82 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Tosymra today: $108.22 each for Tosymra 10 mg nasal spray in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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).
Dollar figures apply FDA’s median drops to the $108.22 pharmacies pay each today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
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 Tosymra
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 Tosymra, before manufacturer rebates.
- $122.7K
- January to March 2026, the latest CMS has posted
For 93 people, about $824 per prescription fill - $415.6K
- 2025, the whole year
For 163 people, about $873 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $122,720 | 93 | $823.62 |
| 2025 | $415,604 | 163 | $873.12 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Tosymra only, so no generic is counted in it. What CMS says it is used for: Sumatriptan is used to treat migraines. It helps to relieve headache, pain, and other migraine symptoms (including nausea, vomiting, sensitivity to light/sound).
Medicaid Prescriptions by Quarter
359 prescriptions in the four quarters to Q1 2026, $242.3K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 96 | $67,028 |
| Q4 2025 | 73 | $48,790 |
| Q3 2025 | 81 | $54,125 |
| Q2 2025 | 109 | $72,403 |
| Q1 2025 | 175 | $118,585 |
Source: CMS Medicaid State Drug Utilization Data, over Tosymra’s own package codes.
Tosymra Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 10MG/SPRAY | Spray | Nasal | January 2019 | Prescription reference product |
Source: FDA Orange Book, Tonix Medicines Inc. Listed for sale today by Upsher-Smith Laboratories, LLC, Promius Pharma, LLC. and Tonix Medicines, Inc. (FDA NDC Directory).
Tosymra NDC Codes and Packages
Each Tosymra package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 00245-0812-61 | SUMATRIPTAN 10 mg/.1mL spray | carton of 6 blister packs of 1 bottle of .1 mL | Upsher-Smith Laboratories, LLC |
| 00245-0812-61 | SUMATRIPTAN 10 mg/.1mL spray | carton of 6 blister packs of 1 bottle of .1 mL | Upsher-Smith Laboratories, LLC |
| 70792-0812-59 | SUMATRIPTAN 10 mg/.1mL spray | bottle of .1 mL | Tonix Medicines, Inc. |
| 70792-0812-61 | SUMATRIPTAN 10 mg/.1mL spray | carton of 6 blister packs of 1 bottle of .1 mL | Tonix Medicines, Inc. |
| 70792-0812-89 | SUMATRIPTAN 10 mg/.1mL spray | bottle of .1 mL | Tonix Medicines, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Tosymra’s own FDA approval (NDA 210884) are listed, never a generic. Some codes belong to companies that repackage Tosymra: it is the same medicine in a different package.
What a Generic Tosymra 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 Tosymra
Is there a generic for Tosymra right now?
Yes. The FDA NDC Directory lists a generic sumatriptan from 6 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Tosymra go generic?
It already has. The FDA NDC Directory lists a generic sumatriptan from 6 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic sumatriptan be the same as Tosymra?
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. The FDA has already approved 4 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Tosymra?
Yes. The FDA Orange Book lists approved generic versions from 4 companies, the first approved in February 2016: Lannett Co Inc, Padagis Israel Pharmaceuticals Ltd, Regcon Holdings LLC and Cipla Ltd. 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 Tosymra patent expire?
The FDA Orange Book lists 9 patents for Tosymra; the last runs to July 2031. The one behind the expected month is patent 9,211,282, which ends in July 2031. 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 month on this page (July 2031) weighs all of that.
How much does Tosymra cost now?
Pharmacies paid about $108.22 each for Tosymra 10 mg nasal spray in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected July 2031 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
- Signifor LARPasireotide PamoateMay 2028
- VizamylFlutemetamol F-18September 2029
- DuzalloAllopurinol and LesinuradFebruary 2032
- IwilfinEflornithine HydrochlorideFebruary 2036
- AnzupgoDelgocitinibSeptember 2036
- OhtuvayreEnsifentrineJune 2038
About Tosymra
- Generic name sumatriptan
- How it is taken In the nose
- Company Tonix Medicines Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with T
- Have a question? A pharmacist answers, free. Ask about Tosymra
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, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.