Ryzumvi Generic: When Will Generic Phentolamine 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
Ryzumvi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? October 2039 About 13 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 patent end? October 2039 11 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic phentolamine mesylate is expected to be available in October 2039, about 13 years away. None is for sale yet.
Why October 2039?
It is when Ryzumvi’s patents 11,400,077, 12,201,615, 12,201,616, 12,576,066 and 1 more 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 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, and more so as more companies sell one. 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. See the price pattern
What should I do now?
Keep taking Ryzumvi 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.
Ryzumvi 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
- Sales not reported
- FDA approved 2023 September 2023 FDA Orange Book
- Patents listed 11 last runs to October 2039 FDA Orange Book
Ryzumvi’s Road to a Generic
Ryzumvi has had the market to itself since the FDA approved it in September 2023 (Famygen Life Sciences Inc). Its FDA protections on record ended by September 2026. Its 11 listed patents run to October 2039. Generic companies have challenged its patents with the FDA since December 2024.
The first generic of Ryzumvi is expected in October 2039.
Why that month: patents 11,400,077, 12,201,615, 12,201,616, 12,576,066 and 1 more, 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.
Ryzumvi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Ryzumvi’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 11,400,077, 12,201,615, 12,201,616, 12,576,066 and 1 more, which end in October 2039, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,795,560 | The product’s formulation | January 2034 | Active |
| 10,278,918 | The product’s formulation | January 2034 | Active |
| 10,772,829 | The product’s formulation | January 2034 | Active |
| 11,090,261 | The product’s formulation | January 2034 | Active |
| 11,844,858 | The product’s formulation | January 2034 | Active |
| 12,350,366 | The product’s formulation | January 2034 | Active |
| 11,400,077 Sets the expected month of generic availability | A way of using it (U-3804) | October 2039 | Active |
| 12,201,615 Sets the expected month of generic availability | A way of using it (U-3804) | October 2039 | Active |
| 12,201,616 Sets the expected month of generic availability | A way of using it (U-3804) | October 2039 | Active |
| 12,576,066 Sets the expected month of generic availability | A way of using it (U-3804) | October 2039 | Active |
| 12,576,067 Sets the expected month of generic availability | A way of using it (U-3804) | October 2039 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | September 2026 | Ended |
Source: FDA Orange Book, application 217064. Patent numbers open the patent on Google Patents.
Patent Challenges to Ryzumvi
The first patent challenge to Ryzumvi reached the FDA in December 2024, 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 Ryzumvi’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 | |||||
| Ophthalmic solution, 0.0075 | December 2024 | 1 company | No decision yet | Not yet | Not yet | 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 Phentolamine Mesylate
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 phentolamine mesylate.
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 Ryzumvi’s patents with the FDA since December 2024: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic phentolamine mesylate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic phentolamine mesylate 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).
Ryzumvi 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 Ryzumvi, 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.
Ryzumvi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 0.75% BASE | Solution | Ophthalmic | September 2023 | Prescription reference product |
Source: FDA Orange Book, Famygen Life Sciences Inc. Listed for sale today by Oyster Point Pharma, Inc. (FDA NDC Directory).
Ryzumvi NDC Codes and Packages
Each Ryzumvi 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 |
|---|---|---|---|
| 83368-0075-30 | PHENTOLAMINE MESYLATE 10 mg/mL solution/ drops | carton of 6 pouches of 5 vials of .2 mL | Oyster Point Pharma, Inc. |
| 83368-0075-31 | PHENTOLAMINE MESYLATE 10 mg/mL solution/ drops | pouch of 5 vials of .2 mL | Oyster Point Pharma, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Ryzumvi’s own FDA approval (NDA 217064) are listed, never a generic. Some codes belong to companies that repackage Ryzumvi: it is the same medicine in a different package.
What a Generic Ryzumvi Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Ryzumvi 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 Ryzumvi”. 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 Ryzumvi
Is there a generic for Ryzumvi right now?
No. As of October 9, 2026 no generic phentolamine mesylate is listed for sale in the FDA NDC Directory.
When will Ryzumvi go generic?
October 2039 is the expected month, and that is probable but not certain. It is when Ryzumvi’s patents 11,400,077, 12,201,615, 12,201,616, 12,576,066 and 1 more end. They cover a way of using it, and once they end, generics can go on sale as soon as the FDA approves them.
Will generic phentolamine mesylate be the same as Ryzumvi?
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. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Ryzumvi?
Not yet. The FDA Orange Book lists no approved generic version of Ryzumvi.
When does the Ryzumvi patent expire?
The FDA Orange Book lists 11 patents for Ryzumvi; the last runs to October 2039. The one behind the expected month is patents 11,400,077, 12,201,615, 12,201,616, 12,576,066 and 1 more, which end in October 2039. 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 (October 2039) weighs all of that.
Has anyone challenged the Ryzumvi patents?
Yes. The first patent challenge to Ryzumvi reached the FDA in December 2024, 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.
Changes to This Projection
- First generic expected October 2039 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
- FlolipidSimvastatinFebruary 2030
- TerlivazTerlipressin AcetateMarch 2030
- BrixadiBuprenorphineJuly 2032
- PizensyLactitol MonohydrateMay 2037
- YorvipathPalopegteriparatide2039 to 2040
- LisrayaBrepocitinib TosylateDuring 2042
About Ryzumvi
- Generic name phentolamine mesylate
- How it is taken In the eye
- Company Famygen Life Sciences Inc
- Patent challenges Since December 2024 (FDA)
- More drugs Brand-name drugs starting with R
- Have a question? A pharmacist answers, free. Ask about Ryzumvi
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.