Tobi Podhaler Generic: When Will Generic Tobramycin 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
Tobi Podhaler Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? November 2030 About 4 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet
- When does the last patent end? November 2030 2 patents listed with the FDA
- Can you buy a generic today? Yes 12 companies list one
It already is. A generic tobramycin is listed for sale by 12 companies, so ask your pharmacy whether it can fill your prescription with one.
Why November 2030?
It is when Tobi Podhaler’s patent 10,207,066 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. It is too early to rate how firm that is.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Tobi Podhaler, 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.
Tobi Podhaler by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Not rated Too early to rate. The month is where the records point today.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2013 March 2013 FDA Orange Book
- Patents listed 2 last runs to November 2030 FDA Orange Book
- Medicare Part D spent $12.8M in 2025, for 374 people CMS Part D Spending by Drug
- Medicaid prescriptions 463 in the last four reported quarters, $5.2M CMS Medicaid drug utilization, to Q1 2026
Tobi Podhaler’s Road to a Generic
Tobi Podhaler has had the market to itself since the FDA approved it in March 2013 (Viatris Specialty LLC). Its 2 listed patents run to November 2030.
The first generic of Tobi Podhaler is expected in November 2030.
Why that month: patent 10,207,066, 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.
Tobi Podhaler Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Tobi Podhaler’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 10,207,066, which ends in November 2030, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,869,794 | The product’s formulation; a way of using it (U-909) | September 2028 | Active |
| 10,207,066 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-909) | November 2030 | Active |
Source: FDA Orange Book, application 201688. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Tobramycin
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 company is recorded as having applied to the FDA to make a generic Tobi Podhaler yet.
Approved by the FDA
Not yet. The FDA has not approved a generic tobramycin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Yes. A generic tobramycin is listed for sale by 12 companies. Ask your pharmacy whether it can fill your prescription with it.
Akorn, American Health Packaging, Amneal Pharmaceuticals LLC, Ascend Laboratories, LLC, Aurobindo Pharma Limited, Genericus, Inc. and 6 more
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).
Tobi Podhaler 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 Tobi Podhaler, 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 Tobi Podhaler
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 Tobi Podhaler, before manufacturer rebates.
- $3.4M
- January to March 2026, the latest CMS has posted
For 228 people, about $11,208 per prescription fill - $12.8M
- 2025, the whole year
For 374 people, about $11,089 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $3,373,708 | 228 | $11,208.33 |
| 2025 | $12,797,126 | 374 | $11,089.36 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Tobi Podhaler only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat people with cystic fibrosis who have an ongoing lung infection with a certain bacteria (Pseudomonas aeruginosa). People with cystic fibrosis produce thick, sticky mucus that can plug up the tubes, ducts and passageways in the lungs.
Medicaid Prescriptions by Quarter
463 prescriptions in the four quarters to Q1 2026, $5.2M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 92 | $1,069,599 |
| Q4 2025 | 119 | $1,341,514 |
| Q3 2025 | 139 | $1,529,886 |
| Q2 2025 | 113 | $1,291,066 |
| Q1 2025 | 131 | $1,496,662 |
Source: CMS Medicaid State Drug Utilization Data, over Tobi Podhaler’s own package codes.
Tobi Podhaler Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 28MG | Powder | Inhalation | March 2013 | Prescription reference product |
Source: FDA Orange Book, Viatris Specialty LLC. Listed for sale today by Mylan Specialty L.P. and Viatris Specialty LLC (FDA NDC Directory).
Tobi Podhaler NDC Codes and Packages
Each Tobi Podhaler 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 |
|---|---|---|---|
| 49502-0346-24 | 28 mg capsule | box of 224 packages of 56 blister packs of 4 capsules | Mylan Specialty L.P. |
| 49502-0401-09 | TOBRAMYCIN 28 mg/1 capsule | box of 8 capsules | Viatris Specialty LLC |
| 49502-0401-09 | TOBRAMYCIN 28 mg/1 capsule | box of 8 capsules | Viatris Specialty LLC |
| 49502-0401-24 | TOBRAMYCIN 28 mg/1 capsule | box of 224 packages of 56 blister packs of 4 capsules | Viatris Specialty LLC |
| 49502-0401-24 | TOBRAMYCIN 28 mg/1 capsule | box of 4 packages of 7 blister packs of 8 capsules | Viatris Specialty LLC |
| 49502-0401-57 | TOBRAMYCIN 28 mg/1 capsule | box of 7 blister packs of 8 capsules | Viatris Specialty LLC |
| 49502-0401-57 | TOBRAMYCIN 28 mg/1 capsule | box of 7 blister packs of 8 capsules | Viatris Specialty LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Tobi Podhaler’s own FDA approval (NDA 201688) are listed, never a generic. Some codes belong to companies that repackage Tobi Podhaler: it is the same medicine in a different package.
What a Generic Tobi Podhaler 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 Tobi Podhaler
Is there a generic for Tobi Podhaler right now?
Yes. The FDA NDC Directory lists a generic tobramycin from 12 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Tobi Podhaler go generic?
It already has. The FDA NDC Directory lists a generic tobramycin from 12 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic tobramycin be the same as Tobi Podhaler?
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. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Tobi Podhaler?
Not yet. The FDA Orange Book lists no approved generic version of Tobi Podhaler.
When does the Tobi Podhaler patent expire?
The FDA Orange Book lists 2 patents for Tobi Podhaler; the last runs to November 2030. The one behind the expected month is patent 10,207,066, which ends in November 2030. 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 (November 2030) weighs all of that.
Changes to This Projection
- First generic expected November 2030 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
- Isentress HDRaltegravir Potassium2028 to 2029
- OdefseyEmtricitabine, Rilpivirine Hydrochloride, and Tenofovir Alafenamide FumarateJanuary 2032
- SeysaraSarecycline HydrochlorideFebruary 2033
- VitrakviLarotrectinib SulfateMay 2037
- DurystaBimatoprostDuring 2041
- AngeliqDrospirenone and EstradiolTBD no date yet
About Tobi Podhaler
- Generic name tobramycin
- How it is taken Inhaled
- Company Viatris Specialty LLC
- 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 Tobi Podhaler
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, 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.