Opsynvi Generic: When Will Generic Macitentan and 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
Opsynvi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2031 About 5 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last FDA protection end? September 2031 FDA exclusivity: pediatric
- Can you buy a generic today? Not yet No company lists one for sale
Generic macitentan and tadalafil is expected to be available in September 2031, about 5 years away. None is for sale yet.
Why September 2031?
It is when Opsynvi’s FDA protection for pediatric ends. Six more months, earned by studying the medicine in children. We rate it probable: more likely than not, but it can still move.
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Opsynvi as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Opsynvi by the Numbers
- Reason
- FDA exclusivity endsFDA gives new drugs a protected period, for example for a rare-disease use. It ends then.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $256M a yearBig seller
- FDA approved 2024 March 2024 FDA Orange Book
- Patents listed 3 last runs to October 2029 FDA Orange Book
- Medicare Part D spent $171.9M in 2025, for 2,049 people CMS Part D Spending by Drug
- Medicaid prescriptions 4,110 in the last four reported quarters, $54.5M CMS Medicaid drug utilization, to Q1 2026
Opsynvi’s Road to a Generic
Opsynvi has had the market to itself since the FDA approved it in March 2024 (Actelion Pharmaceuticals US Inc). Its FDA protection (pediatric) runs to September 2031. Its 3 listed patents run to October 2029 (1 already expired).
The first generic of Opsynvi is expected in September 2031.
Why that month: FDA gives new drugs a protected period, for example for a rare-disease use. 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.
Opsynvi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Opsynvi’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 |
|---|---|---|---|
| 7,094,781 | The active ingredient; the product’s formulation | June 2026 with the pediatric extension | Expired |
| 10,946,015 | The product’s formulation; a way of using it (U-3881) | March 2027 with the pediatric extension | Active |
| 8,268,847 | The product’s formulation; a way of using it (U-3882) | October 2029 with the pediatric extension | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | March 2027 | Active |
| Orphan drug ODE-475 | Seven years of protection for a use in a rare disease. | March 2031 | Active |
| Pediatric PED | Six more months, earned by studying the medicine in children. | September 2031 | Active |
Source: FDA Orange Book, application 218490. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Macitentan and 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
No company is recorded as having applied to the FDA to make a generic Opsynvi yet.
Approved by the FDA
Not yet. The FDA has not approved a generic macitentan and tadalafil. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic macitentan and tadalafil for sale with the FDA.
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).
Opsynvi 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 Opsynvi, 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 Opsynvi
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 Opsynvi, before manufacturer rebates.
- $66.5M
- January to March 2026, the latest CMS has posted
For 1,921 people, about $13,544 per prescription fill - $171.9M
- 2025, the whole year
For 2,049 people, about $13,338 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $66,461,840 | 1,921 | $13,544.29 |
| 2025 | $171,935,426 | 2,049 | $13,337.63 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Opsynvi only, so no generic is counted in it. What CMS says it is used for: This combination medication contains 2 drugs: macitentan and tadalafil. It is used by people who are currently taking stable doses of these 2 drugs to treat high blood pressure in the lungs (pulmonary hypertension).
Medicaid Prescriptions by Quarter
4,110 prescriptions in the four quarters to Q1 2026, $54.5M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 1,303 | $17,659,755 |
| Q4 2025 | 1,241 | $16,308,889 |
| Q3 2025 | 1,004 | $13,254,060 |
| Q2 2025 | 562 | $7,324,996 |
| Q1 2025 | 407 | $5,205,748 |
Source: CMS Medicaid State Drug Utilization Data, over Opsynvi’s own package codes.
Opsynvi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 10MG;20MG | Tablet | Oral | March 2024 | Prescription reference product |
| 10MG;40MG | Tablet | Oral | March 2024 | Prescription reference product |
Source: FDA Orange Book, Actelion Pharmaceuticals US Inc. Listed for sale today by Actelion Pharmaceuticals US, Inc. (FDA NDC Directory).
Opsynvi NDC Codes and Packages
Each Opsynvi 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 |
|---|---|---|---|
| 66215-0812-07 | MACITENTAN 10 mg/1 / TADALAFIL 20 mg/1 tablet, film coated | bottle of 7 tablets | Actelion Pharmaceuticals US, Inc. |
| 66215-0812-08 | MACITENTAN 10 mg/1 / TADALAFIL 20 mg/1 tablet, film coated | blister pack of 7 tablets | Actelion Pharmaceuticals US, Inc. |
| 66215-0812-30 | MACITENTAN 10 mg/1 / TADALAFIL 20 mg/1 tablet, film coated | bottle of 30 tablets | Actelion Pharmaceuticals US, Inc. |
| 66215-0814-10 | MACITENTAN 10 mg/1 / TADALAFIL 40 mg/1 tablet, film coated | blister pack of 10 tablets | Actelion Pharmaceuticals US, Inc. |
| 66215-0814-30 | MACITENTAN 10 mg/1 / TADALAFIL 40 mg/1 tablet, film coated | bottle of 30 tablets | Actelion Pharmaceuticals US, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Opsynvi’s own FDA approval (NDA 218490) are listed, never a generic. Some codes belong to companies that repackage Opsynvi: it is the same medicine in a different package.
What a Generic Opsynvi Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Opsynvi as usual. When one arrives, there is nothing you need to sign up for.
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.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Opsynvi”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Opsynvi
Is there a generic for Opsynvi right now?
No. As of October 9, 2026 no generic macitentan and tadalafil is listed for sale in the FDA NDC Directory.
When will Opsynvi go generic?
September 2031 is the expected month, and that is probable but not certain. It is when Opsynvi’s FDA protection for pediatric ends. Six more months, earned by studying the medicine in children.
Will generic macitentan and tadalafil be the same as Opsynvi?
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 Opsynvi?
Not yet. The FDA Orange Book lists no approved generic version of Opsynvi.
When does the Opsynvi patent expire?
The FDA Orange Book lists 3 patents for Opsynvi; the last runs to October 2029, counting a six-month pediatric extension. 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 (September 2031) weighs all of that.
Changes to This Projection
- First generic expected September 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
- Combivent RespimatAlbuterol Sulfate and Ipratropium BromideOctober 2030
- MiplyffaArimoclomol Citrate2036 to 2037
- Gvoke PFSGlucagonApril 2036
- Radicava ORSEdaravone2037 to 2038
- TymlosAbaloparatideApril 2038
- ZtalmyGanaxoloneSeptember 2042
About Opsynvi
- Generic name macitentan and tadalafil
- How it is taken By mouth
- Company Actelion Pharmaceuticals US Inc
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Opsynvi
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.