Xhance Generic: When Will Generic Fluticasone Propionate 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
Xhance Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2036 About 9.5 years away Why then?
- Has the FDA approved a generic? February 2006 6 companies approved
- When does the last patent end? February 2036 3 patents listed with the FDA
- Can you buy a generic today? Yes 93 companies list one
It already is. A generic fluticasone propionate is listed for sale by 93 companies, so ask your pharmacy whether it can fill your prescription with one.
Why February 2036?
It is when Xhance’s patents 11,554,229 and 12,616,806 end. They cover a way of using it, and once they end, 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 Xhance, 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.
Xhance 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
- Sales not reported
- FDA approved 2017 September 2017 FDA Orange Book
- Patents listed 3 last runs to February 2036 FDA Orange Book
- Generics FDA-approved 6 companies, the first approved February 2006 FDA Orange Book
- Pharmacies pay $40.84 per mL, up 9% in a year NADAC, October 2026
- Medicare Part D spent $25.2M in 2025, for 9,547 people CMS Part D Spending by Drug
- Medicaid prescriptions 15.3K in the last four reported quarters, $11M CMS Medicaid drug utilization, to Q1 2026
Xhance’s Road to a Generic
Xhance has had the market to itself since the FDA approved it in September 2017 (Paratek Pharmaceuticals Inc). Its FDA protection (new use) runs to March 2027. Its 3 listed patents run to February 2036.
The first generic of Xhance is expected in February 2036.
Why that month: patents 11,554,229 and 12,616,806, on a way of using it, end 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.
Xhance Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Xhance’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: patents 11,554,229 and 12,616,806, which end in February 2036, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 12,083,270 | A way of using it (U-2133) | April 2031 | Active |
| 11,554,229 Sets the expected month of generic availability | A way of using it (U-2133) | February 2036 | Active |
| 12,616,806 Sets the expected month of generic availability | A way of using it (U-4524, U-4525) | February 2036 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New use I-940 | Three years of protection for a newly approved use (indication). | March 2027 | Active |
Source: FDA Orange Book, application 209022. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Fluticasone Propionate
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 Xhance, but the FDA has already approved 6 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 6 companies, the first in February 2006. 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 fluticasone propionate is listed for sale by 93 companies. Ask your pharmacy whether it can fill your prescription with it.
30M One, Inc., A-S Medication Solutions, Advagen Pharma Ltd, Advanced Rx Pharmacy of Tennessee, LLC, Akorn, Aldi Inc and 34 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc | February 2006 | 0.05MG/SPRAY | AB |
| Apotex Inc | September 2007 | 0.05MG/SPRAY | AB |
| Chartwell Rx Sciences LLC | January 2012 | 0.05MG/SPRAY | AB |
| Aurobindo Pharma Ltd | May 2024 | 0.05MG/SPRAY | – |
| Rubicon Research Ltd | June 2025 | 0.05MG/SPRAY | AB |
| Glenmark Specialty SA | March 2026 | 0.05MG/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).
Xhance Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Xhance 93 mcg exhalation delivery nasal spray
$40.84 per mL in October 2026, up 9% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per mL |
|---|---|
| October 2026 | $40.84 |
| September 2026 | $40.84 |
| August 2026 | $40.88 |
| July 2026 | $40.87 |
| June 2026 | $40.87 |
| May 2026 | $40.87 |
| April 2026 | $40.90 |
| March 2026 | $40.90 |
| February 2026 | $40.90 |
| January 2026 | $40.90 |
| February 2024 | $37.46 |
| January 2024 | $37.46 |
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 Xhance today: $40.84 per mL for Xhance 93 mcg exhalation delivery 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 $40.84 pharmacies pay per mL 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 Xhance
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 Xhance, before manufacturer rebates.
- $5.9M
- January to March 2026, the latest CMS has posted
For 4,461 people, about $858 per prescription fill - $25.2M
- 2025, the whole year
For 9,547 people, about $835 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $5,850,826 | 4,461 | $858.14 |
| 2025 | $25,182,129 | 9,547 | $835.17 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Xhance only, so no generic is counted in it. What CMS says it is used for: Fluticasone is used to treat a certain condition of the nose (chronic rhinosinusitis with or without nasal polyps). It belongs to a class of drugs known as corticosteroids.
Medicaid Prescriptions by Quarter
15,289 prescriptions in the four quarters to Q1 2026, $11M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 3,730 | $2,735,252 |
| Q4 2025 | 3,991 | $2,846,809 |
| Q3 2025 | 4,093 | $2,968,612 |
| Q2 2025 | 3,475 | $2,469,511 |
| Q1 2025 | 3,536 | $2,538,733 |
Source: CMS Medicaid State Drug Utilization Data, over Xhance’s own package codes.
Xhance Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.093MG/SPRAY | Spray, metered | Nasal | September 2017 | Prescription reference product |
Source: FDA Orange Book, Paratek Pharmaceuticals Inc. Listed for sale today by OptiNose US, Inc. and Paratek Pharmaceuticals, Inc. (FDA NDC Directory).
Xhance NDC Codes and Packages
Each Xhance 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 |
|---|---|---|---|
| 71143-0375-01 | FLUTICASONE PROPIONATE 93 ug/1 spray, metered | bottle of 120 sprays | OptiNose US, Inc. |
| 71143-0375-01 | FLUTICASONE PROPIONATE 93 ug/1 spray, metered | bottle of 120 sprays | OptiNose US, Inc. |
| 71143-0375-98 | FLUTICASONE PROPIONATE 93 ug/1 spray, metered | bottle of 28 sprays | OptiNose US, Inc. |
| 71143-0375-98 | FLUTICASONE PROPIONATE 93 ug/1 spray, metered | bottle of 28 sprays | OptiNose US, Inc. |
| 71143-0375-99 | FLUTICASONE PROPIONATE 93 ug/1 spray, metered | bottle of 120 sprays | OptiNose US, Inc. |
| 71715-0003-31 | FLUTICASONE PROPIONATE 93 ug/1 spray, metered | bottle of 120 sprays | Paratek Pharmaceuticals, Inc. |
| 71715-0003-32 | FLUTICASONE PROPIONATE 93 ug/1 spray, metered | bottle of 28 sprays | Paratek Pharmaceuticals, Inc. |
| 71715-0003-33 | FLUTICASONE PROPIONATE 93 ug/1 spray, metered | bottle of 28 sprays | Paratek Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Xhance’s own FDA approval (NDA 209022) are listed, never a generic. Some codes belong to companies that repackage Xhance: it is the same medicine in a different package.
What a Generic Xhance 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 Xhance
Is there a generic for Xhance right now?
Yes. The FDA NDC Directory lists a generic fluticasone propionate from 93 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Xhance go generic?
It already has. The FDA NDC Directory lists a generic fluticasone propionate from 93 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic fluticasone propionate be the same as Xhance?
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 6 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Xhance?
Yes. The FDA Orange Book lists approved generic versions from 6 companies, the first approved in February 2006: Hikma Pharmaceuticals USA Inc, Apotex Inc, Chartwell Rx Sciences LLC, Aurobindo Pharma Ltd and 2 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 Xhance patent expire?
The FDA Orange Book lists 3 patents for Xhance; the last runs to February 2036. The one behind the expected month is patents 11,554,229 and 12,616,806, which end in February 2036. 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 (February 2036) weighs all of that.
How much does Xhance cost now?
Pharmacies paid about $40.84 per mL for Xhance 93 mcg exhalation delivery 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 February 2036 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
- AddyiFlibanserinMay 2028
- ImvexxyEstradiolDuring 2032
- RiViveNaloxone HydrochlorideMay 2032
- NexletolBempedoic AcidDuring 2033
- DefinityPerflutrenMay 2037
- Veklury IVRemdesivir2039 to 2040
About Xhance
- Generic name fluticasone propionate
- How it is taken In the nose
- Company Paratek Pharmaceuticals 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 X
- Have a question? A pharmacist answers, free. Ask about Xhance
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.