Astepro Generic: When Will Generic Azelastine 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
Astepro Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? April 2009 6 companies approved
- When does the last patent end? June 2028 Its only patent listed with the FDA
- Can you buy a generic today? Yes 26 companies list one
It already is. A generic azelastine hydrochloride is listed for sale by 26 companies, so ask your pharmacy whether it can fill your prescription with one.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Astepro, 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.
Astepro 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
- Not rated Too early to rate.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- Sales not reported
- FDA approved 2008 October 2008 FDA Orange Book
- Patents listed 1 last runs to June 2028 FDA Orange Book
- Generics FDA-approved 6 companies, the first approved April 2009 FDA Orange Book
Astepro’s Road to a Generic
Astepro has had the market to itself since the FDA approved it in October 2008 (Viatris Specialty LLC). Its one listed patent runs to June 2028. Generic companies have challenged its patents with the FDA since December 2011.
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
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.
Astepro Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Astepro’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 |
|---|---|---|---|
| 8,071,073 | The product’s formulation | June 2028 | Active |
Source: FDA Orange Book, application 022203. Patent numbers open the patent on Google Patents.
Patent Challenges to Astepro
The first patent challenge to Astepro reached the FDA in December 2011.
What Is a Patent Challenge?
A generic company that wants to sell its version before Astepro’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 | |||||
| Nasal spray, 205.5 mcg/spray | December 2011 | Not given | Not posted | Not posted | Not posted | Not given |
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 Azelastine Hydrochloride
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 6 companies have applied to the FDA to make generic azelastine hydrochloride.
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 Astepro’s patents with the FDA since December 2011: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 6 companies, the first in April 2009. 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 azelastine hydrochloride is listed for sale by 26 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Akorn, Allegiant Health, Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals NY LLC, Apotex Corp. and 20 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Apotex Inc | April 2009 | 0.137MG/SPRAY, 0.2055MG/SPRAY | AB |
| Zydus Pharmaceuticals USA Inc | August 2017 | 0.137MG/SPRAY | AB |
| Alkem Laboratories Ltd | August 2017 | 0.137MG/SPRAY | AB |
| Amneal Pharmaceuticals LLC | August 2017 | 0.137MG/SPRAY, 0.2055MG/SPRAY | AB |
| Epic Pharma LLC | May 2019 | 0.137MG/SPRAY | AB |
| Aurobindo Pharma Ltd | May 2020 | 0.137MG/SPRAY, 0.2055MG/SPRAY | AB |
| Sun Pharmaceutical Industries Ltd discontinued | May 2012 | 0.137MG/SPRAY | – |
| Padagis Israel Pharmaceuticals Ltd discontinued | May 2014 | 0.2055MG/SPRAY | – |
| Hikma Pharmaceuticals USA Inc discontinued | October 2014 | 0.137MG/SPRAY, 0.2055MG/SPRAY | – |
| Bionpharma Inc discontinued | July 2015 | 0.137MG/SPRAY | – |
| Padagis US LLC discontinued | March 2017 | 0.137MG/SPRAY | – |
| Sciegen Pharmaceuticals Inc discontinued | August 2019 | 0.2055MG/SPRAY | – |
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).
Astepro 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 Astepro, 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.
Astepro Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Spray, metered | Nasal | October 2008 | Discontinued reference product |
| 0.2055MG/SPRAY | Spray, metered | Nasal | August 2009 | Discontinued |
Source: FDA Orange Book, Viatris Specialty LLC.
What a Generic Astepro 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 Astepro
Is there a generic for Astepro right now?
Yes. The FDA NDC Directory lists a generic azelastine hydrochloride from 26 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Astepro go generic?
It already has. The FDA NDC Directory lists a generic azelastine hydrochloride from 26 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic azelastine hydrochloride be the same as Astepro?
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 6 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 Astepro?
Yes. The FDA Orange Book lists approved generic versions from 6 companies, the first approved in April 2009: Apotex Inc, Zydus Pharmaceuticals USA Inc, Alkem Laboratories Ltd, Amneal Pharmaceuticals LLC 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 Astepro patent expire?
One patent is listed for Astepro in the FDA Orange Book; it runs to June 2028. 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 (a date that is not known yet) weighs all of that.
Has anyone challenged the Astepro patents?
Yes. The first patent challenge to Astepro reached the FDA in December 2011. 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 a date that is not known yet 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
- QVAR RediHalerBeclomethasone Dipropionate2032 to 2033
- ZolpimistZolpidem TartrateAugust 2032
- MiplyffaArimoclomol Citrate2036 to 2037
- Gvoke PFSGlucagonApril 2036
- TuralioPexidartinib HydrochlorideJuly 2038
- CleviprexClevidipineTBD no date yet
About Astepro
- Generic name azelastine hydrochloride
- How it is taken In the nose
- Company Viatris Specialty LLC
- Patent challenges Since December 2011 (FDA)
- More drugs Brand-name drugs starting with A
- Have a question? A pharmacist answers, free. Ask about Astepro
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.