Phenylephrine Hydrochloride Generic: When Will It 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
Phenylephrine Hydrochloride 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 2018 17 companies approved
- When does the last patent end? September 2036 4 patents listed with the FDA
- Can you buy a generic today? Yes 11 companies list one
It already is. A generic phenylephrine hydrochloride is listed for sale by 11 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 Phenylephrine Hydrochloride, 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.
Phenylephrine Hydrochloride by the Numbers
- Reason
- Not yet clearNo generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
- How sure
- Not rated Too early to rate.
- Price competition
- None filed yet No filers on record
- Brand sales
- under $10M a yearSmall seller
- FDA approved 2012 December 2012 FDA Orange Book
- Patents listed 4 last runs to September 2036 FDA Orange Book
- Generics FDA-approved 17 companies, the first approved April 2018 FDA Orange Book
- Pharmacies pay $9.29 per mL NADAC, October 2026
- Medicaid prescriptions 7,943 in the last four reported quarters, $1.1M CMS Medicaid drug utilization, to Q1 2026
Phenylephrine Hydrochloride’s Road to a Generic
Phenylephrine Hydrochloride has had the market to itself since the FDA approved it in December 2012 (Alcon Research LLC). Its 4 listed patents run to September 2036.
No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
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.
Phenylephrine Hydrochloride Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Phenylephrine Hydrochloride’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 |
|---|---|---|---|
| 8,859,623 | A way of using it (U-1594) | November 2033 | Active |
| 11,471,400 | The product’s formulation | August 2036 | Active |
| 11,213,480 | The product’s formulation | September 2036 | Active |
| 12,257,342 | The product’s formulation | September 2036 | Active |
Source: FDA Orange Book, application 207926, 203510, 203826. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Phenylephrine 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
No application count is on record for Phenylephrine Hydrochloride, but the FDA has already approved 17 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 17 companies, the first in April 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 phenylephrine hydrochloride is listed for sale by 11 companies. Ask your pharmacy whether it can fill your prescription with it.
Bausch & Lomb Americas Inc., Caplin Steriles Limited, Dr.Reddy's Laboratories Inc.,, First Nation Group, LLC, Gland Pharma Limited, Leading Pharma, LLC and 5 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Meitheal Pharmaceuticals Inc | April 2018 | 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AP2, AP1 |
| Amneal Eu Ltd | July 2018 | 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AP1 |
| Ph Health Ltd | December 2018 | 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AP1 |
| Fresenius Kabi USA LLC | January 2019 | 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AP2, AP1 |
| Sandoz Inc | January 2019 | 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AP1 |
| Sagent Pharmaceuticals Inc | January 2020 | 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AP1 |
| Gland Pharma Ltd | June 2020 | 2.5%, 10%, 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AT, AP1 |
| Caplin Steriles Ltd | June 2020 | 2.5%, 10%, 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AT, AP1 |
| Milla Pharmaceuticals Inc | July 2020 | 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AP1 |
| Eugia Pharma Specialities Ltd | November 2020 | 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AP2, AP1 |
| Mankind Pharma Ltd | August 2022 | 2.5%, 10%, 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AT, AP1 |
| Avet Lifesciences Private Ltd | February 2023 | 10MG/ML (10MG/ML) | AP2 |
| Be Pharmaceuticals AG | June 2023 | 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AP2 |
| Hainan Poly Pharm Co Ltd | March 2024 | 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AP1 |
| Aspiro Pharma Ltd | May 2024 | 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AP1 |
| Somerset Therapeutics LLC | February 2025 | 0.5MG/5ML (0.1MG/ML) | AP |
| Baxter Healthcare Corp | April 2026 | 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | AP1 |
| Accord Healthcare Inc discontinued | July 2020 | 10MG/ML (10MG/ML), 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML) | – |
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).
Phenylephrine Hydrochloride Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Phenylephrine 2.5% eye drop
$9.29 per mL in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
- Phenylephrine 2.5% eye drop $9.29 per mL
- Phenylephrine 10% eye drop $5.24 per mL
See the numbers
| Month | Pharmacies paid per mL |
|---|---|
| October 2026 | $9.29 |
| September 2026 | $9.29 |
| August 2026 | $9.20 |
| July 2026 | $9.28 |
| June 2026 | $9.20 |
| May 2026 | $9.08 |
| April 2026 | $8.98 |
| March 2026 | $8.72 |
| February 2026 | $8.55 |
| January 2026 | $8.59 |
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 Phenylephrine Hydrochloride today: $9.29 per mL for Phenylephrine 2.5% eye drop 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).
Dollar figures apply FDA’s median drops to the $9.29 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 Phenylephrine Hydrochloride
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.
Medicaid Prescriptions by Quarter
7,943 prescriptions in the four quarters to Q1 2026, $1.1M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 1,653 | $83,462 |
| Q4 2025 | 2,165 | $265,198 |
| Q3 2025 | 2,076 | $396,397 |
| Q2 2025 | 2,049 | $378,768 |
| Q1 2025 | 2,084 | $417,138 |
Source: CMS Medicaid State Drug Utilization Data, over Phenylephrine Hydrochloride’s own package codes.
Phenylephrine Hydrochloride Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 10MG/ML (10MG/ML) | Solution | Intravenous | December 2012 | Prescription reference product |
| 10% | Solution/drops | Ophthalmic | January 2015 | Prescription reference product |
| 2.5% | Solution/drops | Ophthalmic | January 2015 | Prescription reference product |
| 100MG/10ML (10MG/ML) | Solution | Intravenous | June 2019 | Prescription reference product |
| 50MG/5ML (10MG/ML) | Solution | Intravenous | June 2019 | Prescription reference product |
Source: FDA Orange Book, Alcon Research LLC. Listed for sale today by Hikma Pharmaceuticals USA Inc., Akorn, Paragon BioTeck, Inc., A-S Medication Solutions and 3 more (FDA NDC Directory).
Phenylephrine Hydrochloride NDC Codes and Packages
Each Phenylephrine Hydrochloride 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 |
|---|---|---|---|
| 17478-0201-02 | 25 mg/mL solution/ drops | bottle of 2 mL | Akorn |
| 17478-0201-15 | 25 mg/mL solution/ drops | bottle of 15 mL | Akorn |
| 17478-0206-05 | 100 mg/mL solution/ drops | bottle of 5 mL | Akorn |
| 00641-6142-25 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | carton of 25 vials of 1 mL | Hikma Pharmaceuticals USA Inc. |
| 00641-6142-25 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | carton of 25 vials of 1 mL | Hikma Pharmaceuticals USA Inc. |
| 00641-6188-10 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | carton of 10 vials of 5 mL | Hikma Pharmaceuticals USA Inc. |
| 00641-6188-10 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | carton of 10 vials of 5 mL | Hikma Pharmaceuticals USA Inc. |
| 00641-6189-10 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | carton of 10 vials of 10 mL | Hikma Pharmaceuticals USA Inc. |
Show the other 18 Phenylephrine Hydrochloride packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 00641-6189-10 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | carton of 10 vials of 10 mL | Hikma Pharmaceuticals USA Inc. |
| 00641-6229-25 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | carton of 25 vials of 1 mL | Hikma Pharmaceuticals USA Inc. |
| 00641-6229-25 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | carton of 25 vials of 1 mL | Hikma Pharmaceuticals USA Inc. |
| 71872-7043-01 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | vial of 1 mL | Medical Purchasing Solutions, LLC |
| 71872-7043-01 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | vial of 1 mL | Medical Purchasing Solutions, LLC |
| 72572-0570-10 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | carton of 10 vials of 10 mL | Civica, Inc. |
| 72572-0570-10 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | carton of 10 vials of 10 mL | Civica, Inc. |
| 72572-0571-25 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | carton of 25 vials of 1 mL | Civica, Inc. |
| 72572-0571-25 | PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL injection | carton of 25 vials of 1 mL | Civica, Inc. |
| 00065-0343-02 | PHENYLEPHRINE HYDROCHLORIDE 100 mg/mL solution/ drops | bottle of 5 mL | Alcon Laboratories, Inc. |
| 42702-0103-05 | PHENYLEPHRINE HYDROCHLORIDE 100 mg/mL solution/ drops | bottle of 5 mL | Paragon BioTeck, Inc. |
| 42702-0103-05 | PHENYLEPHRINE HYDROCHLORIDE 100 mg/mL solution/ drops | bottle of 5 mL | Paragon BioTeck, Inc. |
| 00065-0349-04 | PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL solution/ drops | bottle of 15 mL | Alcon Laboratories, Inc. |
| 00065-0349-05 | PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL solution/ drops | bottle of 2 mL | Alcon Laboratories, Inc. |
| 42702-0102-10 | PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL solution/ drops | bottle of 10 mL | Paragon BioTeck, Inc. |
| 42702-0102-10 | PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL solution/ drops | bottle of 10 mL | Paragon BioTeck, Inc. |
| 42702-0102-15 | PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL solution/ drops | bottle of 15 mL | Paragon BioTeck, Inc. |
| 42702-0102-15 | PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL solution/ drops | bottle of 15 mL | Paragon BioTeck, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Phenylephrine Hydrochloride’s own FDA approval (NDA 207926, NDA 203510, NDA 203826) are listed, never a generic. Some codes belong to companies that repackage Phenylephrine Hydrochloride: it is the same medicine in a different package.
What a Generic Phenylephrine Hydrochloride 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 Phenylephrine Hydrochloride
Is there a generic for Phenylephrine Hydrochloride right now?
Yes. The FDA NDC Directory lists a generic phenylephrine hydrochloride from 11 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Phenylephrine Hydrochloride go generic?
It already has. The FDA NDC Directory lists a generic phenylephrine hydrochloride from 11 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic phenylephrine hydrochloride be the same as Phenylephrine Hydrochloride?
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. The FDA has already approved 17 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Phenylephrine Hydrochloride?
Yes. The FDA Orange Book lists approved generic versions from 17 companies, the first approved in April 2018: Meitheal Pharmaceuticals Inc, Amneal Eu Ltd, Ph Health Ltd, Fresenius Kabi USA LLC and 13 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 Phenylephrine Hydrochloride patent expire?
The FDA Orange Book lists 4 patents for Phenylephrine Hydrochloride; the last runs to September 2036. 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.
How much does Phenylephrine Hydrochloride cost now?
Pharmacies paid about $9.29 per mL for Phenylephrine 2.5% eye drop 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 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
- InlytaAxitinib2027 to 2028
- VerkaziaCyclosporineJune 2028
- RybelsusSemaglutide2032 to 2033
- NityrNitisinoneJanuary 2035
- DextenzaDexamethasoneNovember 2037
- AktenLidocaine HydrochlorideTBD no date yet
About Phenylephrine Hydrochloride
- Generic name phenylephrine hydrochloride
- How it is taken In the eye
- Company Alcon Research LLC
- More drugs Brand-name drugs starting with P
- Have a question? A pharmacist answers, free. Ask about Phenylephrine Hydrochloride
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, NADAC (CMS), Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.