Tadliq Generic: When Will Generic Tadalafil 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
Tadliq Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2030 to 2031 A wide window Why then?
- Has the FDA approved a generic? May 2018 29 companies approved
- When does the last patent end? December 2038 8 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 59 companies list one
It already is. A generic tadalafil is listed for sale by 59 companies, so ask your pharmacy whether it can fill your prescription with one.
Why 2030 to 2031?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it probable: more likely than not, but it can still move.
If Tadliq’s last patent runs to December 2038, how can a generic come sooner?
The 8 patents that run past the expected month, to December 2038 (11,382,917, 11,666,576, 11,975,006, 12,186,322 and 4 more), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, the companies are expected to settle on a date. Generic companies have been challenging Tadliq’s patents with the FDA since December 2025. That is why the expected month comes before the last protection ends. See the road to a generic
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Tadliq, 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.
Tadliq by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- 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
- $19M a yearSmaller seller
- FDA approved 2022 June 2022 FDA Orange Book
- Patents listed 8 last runs to December 2038 FDA Orange Book
- Generics FDA-approved 29 companies, the first approved May 2018 FDA Orange Book
- Pharmacies pay $13.59 per mL NADAC, October 2026
- Medicare Part D spent $224.1K in 2025, for 19 people CMS Part D Spending by Drug
- Medicaid prescriptions 7,210 in the last four reported quarters, $12.6M CMS Medicaid drug utilization, to Q1 2026
Tadliq’s Road to a Generic
Tadliq has had the market to itself since the FDA approved it in June 2022 (Cmp Development LLC). Its 8 listed patents run to December 2038. Generic companies have challenged its patents with the FDA since December 2025.
The first generic of Tadliq is expected between 2030 and 2031.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Why a Generic Can Come Before December 2038
The last listed patent runs to December 2038, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
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.
Tadliq Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Tadliq’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 |
|---|---|---|---|
| 11,382,917 | The product’s formulation; a way of using it (U-3397) | December 2038 | Active |
| 11,666,576 | The product’s formulation; a way of using it (U-3397) | December 2038 | Active |
| 11,975,006 | The product’s formulation; a way of using it (U-3397) | December 2038 | Active |
| 12,186,322 | The product’s formulation; a way of using it (U-3397) | December 2038 | Active |
| 12,691,120 | The product’s formulation; a way of using it (U-3397) | December 2038 | Active |
| 12,697,338 | The product’s formulation; a way of using it (U-3397) | December 2038 | Active |
| 12,708,626 | The product’s formulation; a way of using it (U-3397) | December 2038 | Active |
| 12,721,849 | The product’s formulation; a way of using it (U-3397) | December 2038 | Active |
Source: FDA Orange Book, application 214522. Patent numbers open the patent on Google Patents.
Patent Challenges to Tadliq
The first patent challenge to Tadliq reached the FDA in December 2025, 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 Tadliq’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 | |||||
| Oral suspension, 20 mg/5 mL | December 2025 | 1 company | No decision yet | Not yet | Not yet | December 2038 |
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 Tadalafil
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 29 companies have applied to the FDA to make generic tadalafil.
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 Tadliq’s patents with the FDA since December 2025: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 29 companies, the first in May 2018. 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 tadalafil is listed for sale by 59 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Accord Healthcare Inc., Advanced Rx of Tennessee, LLC, Ajanta Pharma USA Inc., Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited and 34 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Teva Pharmaceuticals USA | May 2018 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Ajanta Pharma Ltd | February 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1, AB2 |
| Aurobindo Pharma Ltd | February 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1, AB2 |
| Chartwell Rx Sciences LLC | February 2019 | 2.5MG, 5MG, 10MG, 20MG | AB2 |
| Cipla Ltd | February 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1, AB2 |
| Dr Reddys Laboratories Ltd | February 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1, AB2 |
| Hetero Labs Ltd Unit III | February 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1, AB2 |
| Teva Pharmaceuticals USA Inc | February 2019 | 20MG | AB2 |
| Accord Healthcare Inc | March 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Alembic Pharmaceuticals Ltd | March 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Amneal Pharmaceuticals Co GmbH | March 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Lupin Ltd | March 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Qilu Pharmaceutical Hainan Co Ltd | March 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Sun Pharmaceutical Industries Ltd | March 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Sunshine Lake Pharma Co Ltd | March 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1, AB2 |
| Torrent Pharmaceuticals Ltd | March 2019 | 2.5MG, 5MG, 10MG, 20MG, 40MG | AB1, AB2 |
| Unichem Laboratories Ltd | March 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Zydus Pharmaceuticals USA Inc | March 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Watson Laboratories Inc | March 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Macleods Pharmaceuticals Ltd | October 2019 | 2.5MG, 5MG, 10MG, 20MG | AB1, AB2 |
| Umedica Laboratories Private Ltd | October 2020 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Hangzhou Minsheng Binjiang Pharmaceutical Co Ltd | October 2020 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Vkt Pharma Private Ltd | November 2021 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Prinston Pharmaceutical Inc | August 2022 | 2.5MG, 5MG, 10MG, 20MG | AB1, AB2 |
| Teva Pharmaceuticals Inc | October 2022 | 20MG | AB2 |
| Novitium Pharma LLC | March 2023 | 5MG, 10MG, 20MG | AB1 |
| Shandong New Time Pharmaceutical Co Ltd | March 2024 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Fourrts India Laboratories Private Ltd | August 2024 | 2.5MG, 5MG, 10MG, 20MG | AB1 |
| Jubilant Generics Ltd | May 2026 | 2.5MG, 5MG, 10MG, 20MG | AB1, AB2 |
| Pharmobedient Consulting LLC discontinued | August 2018 | 5MG, 20MG | – |
| Rising Pharma Holding Inc discontinued | April 2019 | 2.5MG, 10MG, 20MG | – |
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).
Tadliq Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Tadliq 20 mg/5 mL suspension
$13.59 per mL in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per mL |
|---|---|
| October 2026 | $13.59 |
| September 2026 | $13.59 |
| August 2026 | $13.07 |
| July 2026 | $13.06 |
| February 2026 | $12.77 |
| January 2026 | $12.77 |
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 Tadliq today: $13.59 per mL for Tadliq 20 mg/5 mL suspension 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). Tadliq has 29 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $13.59 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 Tadliq
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 Tadliq, before manufacturer rebates.
- $104.6K
- January to March 2026, the latest CMS has posted
For 13 people, about $3,268 per prescription fill - $224.1K
- 2025, the whole year
For 19 people, about $2,949 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $104,589 | 13 | $3,268.42 |
| 2025 | $224,136 | 19 | $2,949.16 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Tadliq only, so no generic is counted in it. What CMS says it is used for: Tadalafil is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily.
Medicaid Prescriptions by Quarter
7,210 prescriptions in the four quarters to Q1 2026, $12.6M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 1,981 | $3,942,753 |
| Q4 2025 | 1,844 | $3,109,205 |
| Q3 2025 | 1,738 | $2,884,455 |
| Q2 2025 | 1,647 | $2,664,294 |
| Q1 2025 | 1,601 | $2,685,607 |
Source: CMS Medicaid State Drug Utilization Data, over Tadliq’s own package codes.
Tadliq Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 20MG/5ML | Suspension | Oral | June 2022 | Prescription reference product |
Source: FDA Orange Book, Cmp Development LLC. Listed for sale today by CMP Pharma, Inc. (FDA NDC Directory).
Tadliq NDC Codes and Packages
Each Tadliq 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 |
|---|---|---|---|
| 46287-0045-15 | TADALAFIL 20 mg/5mL suspension | bottle of 150 mL | CMP Pharma, Inc. |
| 46287-0045-15 | TADALAFIL 20 mg/5mL suspension | bottle of 150 mL | CMP Pharma, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Tadliq’s own FDA approval (NDA 214522) are listed, never a generic. Some codes belong to companies that repackage Tadliq: it is the same medicine in a different package.
What a Generic Tadliq 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 Tadliq
Is there a generic for Tadliq right now?
Yes. The FDA NDC Directory lists a generic tadalafil from 59 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Tadliq go generic?
It already has. The FDA NDC Directory lists a generic tadalafil from 59 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic tadalafil be the same as Tadliq?
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 29 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, which would take the $13.59 pharmacies pay per mL for Tadliq today to under $0.68. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Tadliq?
Yes. The FDA Orange Book lists approved generic versions from 29 companies, the first approved in May 2018: Teva Pharmaceuticals USA, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Chartwell Rx Sciences LLC and 25 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 Tadliq patent expire?
The FDA Orange Book lists 8 patents for Tadliq; the last runs to December 2038. 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 (2030 to 2031) weighs all of that.
Has anyone challenged the Tadliq patents?
Yes. The first patent challenge to Tadliq reached the FDA in December 2025, 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 Tadliq cost now?
Pharmacies paid about $13.59 per mL for Tadliq 20 mg/5 mL suspension 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 2030 to 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
- NevanacNepafenacJanuary 2027
- DefencathHeparin Sodium and TaurolidineJuly to December 2035
- ImmphentivPhenylephrine HydrochlorideSeptember 2036
- AdlarityDonepezilAugust 2038
- RivflozaNedosiran SodiumOctober 2038
- Veklury IVRemdesivir2039 to 2040
About Tadliq
- Generic name tadalafil
- How it is taken By mouth
- Company Cmp Development LLC
- Patent challenges Since December 2025 (FDA)
- More drugs Brand-name drugs starting with T
- Have a question? A pharmacist answers, free. Ask about Tadliq
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.