Spiriva Respimat Generic: When Will Generic Tiotropium 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
Spiriva Respimat Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? April 2031 About 4.5 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? April 2031 4 patents listed with the FDA
- Can you buy a generic today? Yes 1 company lists one
It already is. A generic tiotropium bromide monohydrate is listed for sale by 1 company, so ask your pharmacy whether it can fill your prescription with one.
Why April 2031?
It is when Spiriva Respimat’s patents 7,396,341 and 8,733,341 end. They cover the product’s formulation, and once they end, generics can go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Spiriva Respimat, 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.
Spiriva Respimat by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- $1.6B a yearBlockbuster
- FDA approved 2014 September 2014 FDA Orange Book
- Patents listed 4 last runs to April 2031 FDA Orange Book
- Pharmacies pay $126.12 per gram, up 0.1% in a year NADAC, October 2026
- Medicare Part D spent $816.1M in 2025, for 297K people CMS Part D Spending by Drug
- Medicaid prescriptions 284.1K in the last four reported quarters, $160.5M CMS Medicaid drug utilization, to Q1 2026
Spiriva Respimat’s Road to a Generic
Spiriva Respimat has had the market to itself since the FDA approved it in September 2014 (Boehringer Ingelheim Pharmaceuticals Inc). Its 4 listed patents run to April 2031. Generic companies have challenged its patents with the FDA since March 2023.
The first generic of Spiriva Respimat is expected in April 2031.
Why that month: patents 7,396,341 and 8,733,341, on the product’s formulation, 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.
Spiriva Respimat Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Spiriva Respimat’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 7,396,341 and 8,733,341, which end in April 2027; the first generic is expected after it, in April 2031, about 4.5 years away.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,396,341 Sets the expected month of generic availability | The product’s formulation | April 2027 with the pediatric extension | Active delisting requested |
| 9,027,967 | The product’s formulation | September 2027 with the pediatric extension | Active delisting requested |
| 7,837,235 | The product’s formulation | September 2028 with the pediatric extension | Active delisting requested |
| 8,733,341 Sets the expected month of generic availability | The product’s formulation | April 2031 with the pediatric extension | Active delisting requested |
Source: FDA Orange Book, application 021936. Patent numbers open the patent on Google Patents.
Patent Challenges to Spiriva Respimat
The first patent challenge to Spiriva Respimat reached the FDA in March 2023, 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 Spiriva Respimat’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 | |||||
| Inhalation aerosol, 2.5 mcg per actuation | March 2023 | 1 company | No decision yet | Not yet | Not yet | April 2031 |
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 Tiotropium Bromide Monohydrate
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
One company has applied to the FDA to make generic tiotropium bromide monohydrate.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for this one yet, so the company is not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
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 Spiriva Respimat’s patents with the FDA since March 2023: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic tiotropium bromide monohydrate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Yes. A generic tiotropium bromide monohydrate is listed for sale by 1 company. Ask your pharmacy whether it can fill your prescription with it.
Lupin Pharmaceuticals, Inc.
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).
Spiriva Respimat Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Spiriva respimat 2.5 mcg inh
$126.12 per gram in October 2026, up 0.1% 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 gram |
|---|---|
| October 2026 | $126.12 |
| September 2026 | $126.12 |
| August 2026 | $126.12 |
| July 2026 | $126.13 |
| June 2026 | $126.16 |
| May 2026 | $126.14 |
| April 2026 | $126.14 |
| March 2026 | $126.13 |
| February 2026 | $126.17 |
| January 2026 | $126.18 |
| February 2024 | $125.96 |
| January 2024 | $125.96 |
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 Spiriva Respimat today: $126.12 per gram for Spiriva respimat 2.5 mcg inh 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). Spiriva Respimat has one company lined up, so our estimate uses the figure for one company. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $126.12 pharmacies pay per gram 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 Spiriva Respimat
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 Spiriva Respimat, before manufacturer rebates.
- $185.5M
- January to March 2026, the latest CMS has posted
For 170,618 people, about $678 per prescription fill - $816.1M
- 2025, the whole year
For 297,018 people, about $694 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $185,451,803 | 170,618 | $677.65 |
| 2025 | $816,076,127 | 297,018 | $693.77 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Spiriva Respimat only, so no generic is counted in it. What CMS says it is used for: Tiotropium is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema). It must be used regularly to prevent wheezing and shortness of breath.
Medicaid Prescriptions by Quarter
284,113 prescriptions in the four quarters to Q1 2026, $160.5M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 65,748 | $36,894,488 |
| Q4 2025 | 72,388 | $41,012,024 |
| Q3 2025 | 73,941 | $42,025,374 |
| Q2 2025 | 72,036 | $40,573,448 |
| Q1 2025 | 72,708 | $41,054,199 |
Source: CMS Medicaid State Drug Utilization Data, over Spiriva Respimat’s own package codes.
Spiriva Respimat Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 0.0025MG BASE/INH | Spray, metered | Inhalation | September 2014 | Prescription reference product |
| EQ 0.00125MG BASE/INH | Spray, metered | Inhalation | September 2015 | Prescription reference product |
Source: FDA Orange Book, Boehringer Ingelheim Pharmaceuticals Inc. Listed for sale today by Boehringer Ingelheim Pharmaceuticals, Inc. (FDA NDC Directory).
Spiriva Respimat NDC Codes and Packages
Each Spiriva Respimat 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 |
|---|---|---|---|
| 00597-0100-28 | TIOTROPIUM BROMIDE ANHYDROUS 3.124 ug/1 spray, metered | cartridge of 28 sprays | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0100-28 | TIOTROPIUM BROMIDE ANHYDROUS 3.124 ug/1 spray, metered | cartridge of 28 sprays | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0100-51 | TIOTROPIUM BROMIDE ANHYDROUS 3.124 ug/1 spray, metered | cartridge of 10 sprays | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0100-51 | TIOTROPIUM BROMIDE ANHYDROUS 3.124 ug/1 spray, metered | cartridge of 10 sprays | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0100-61 | TIOTROPIUM BROMIDE ANHYDROUS 3.124 ug/1 spray, metered | cartridge of 60 sprays | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0100-61 | TIOTROPIUM BROMIDE ANHYDROUS 3.124 ug/1 spray, metered | cartridge of 60 sprays | Boehringer Ingelheim Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Spiriva Respimat’s own FDA approval (NDA 21936) are listed, never a generic. Some codes belong to companies that repackage Spiriva Respimat: it is the same medicine in a different package.
What a Generic Spiriva Respimat 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 Spiriva Respimat
Is there a generic for Spiriva Respimat right now?
Yes. The FDA NDC Directory lists a generic tiotropium bromide monohydrate from 1 company. Ask your pharmacy whether it can fill your prescription with it.
When will Spiriva Respimat go generic?
It already has. The FDA NDC Directory lists a generic tiotropium bromide monohydrate from 1 company, so ask your pharmacy whether it can fill your prescription with one.
Will generic tiotropium bromide monohydrate be the same as Spiriva Respimat?
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. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic, which would take the $126.12 pharmacies pay per gram for Spiriva Respimat today to about $87.02. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Spiriva Respimat?
Not yet. The FDA Orange Book lists no approved generic version of Spiriva Respimat.
When does the Spiriva Respimat patent expire?
The FDA Orange Book lists 4 patents for Spiriva Respimat; the last runs to April 2031, counting a six-month pediatric extension. The one behind the expected month is patents 7,396,341 and 8,733,341, which end in April 2027. 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 (April 2031) weighs all of that.
Has anyone challenged the Spiriva Respimat patents?
Yes. The first patent challenge to Spiriva Respimat reached the FDA in March 2023, 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.
How much does Spiriva Respimat cost now?
Pharmacies paid about $126.12 per gram for Spiriva respimat 2.5 mcg inh 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 April 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
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- TukysaTucatinibApril 2034
- GvokeGlucagonApril 2036
- MimryloRusfertide2037 to 2038
- CloticClotrimazoleSeptember 2037
- QuviviqDaridorexant Hydrochloride2038 to 2039
About Spiriva Respimat
- Generic name tiotropium bromide monohydrate
- How it is taken Inhaled
- Company Boehringer Ingelheim Pharmaceuticals Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since March 2023 (FDA)
- More drugs Brand-name drugs starting with S
- Have a question? A pharmacist answers, free. Ask about Spiriva Respimat
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, 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.