Isentress Generic: When Will Generic Raltegravir 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
Isentress Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2029 About 3 years away Why then?
- Has the FDA approved a generic? December 2024 2 companies approved
- When does the last patent end? March 2032 5 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 1 company lists one
It already is. A generic raltegravir potassium is listed for sale by 1 company, so ask your pharmacy whether it can fill your prescription with one.
Why September 2029?
It is when Isentress’s patent 7,754,731 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
If Isentress’s last patent runs to March 2032, how can a generic come sooner?
The 3 patents that run past the expected month, to March 2032 (8,771,733, 9,649,311 and 10,772,888), cover the active ingredient, the product’s formulation and a way of using it. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. Generic companies have been challenging Isentress’s patents with the FDA since October 2011. 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 Isentress, but the active ingredient, strength and form are the same. What a generic means for you
- oral suspensionSeptember 2029Toss-up · patent expires
- chewable tabletsJune 2030Toss-up · patent expires
- 400 mg tableta date that is not known yetNot rated · settlement between companies
Our month is only an estimate based on available information, so we never name a day.
Isentress by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- under $10M a yearSmall seller
- FDA approved 2007 October 2007 FDA Orange Book
- Patents listed 5 last runs to March 2032 FDA Orange Book
- Generics FDA-approved 2 companies, the first approved December 2024 FDA Orange Book
- Pharmacies pay $34.54 per tablet, up 6.8% in a year NADAC, October 2026
- Medicare Part D spent $99.6M in 2025, for 5,586 people CMS Part D Spending by Drug
- Medicaid prescriptions 15.9K in the last four reported quarters, $32.4M CMS Medicaid drug utilization, to Q1 2026
Isentress’s Road to a Generic
Isentress has had the market to itself since the FDA approved it in October 2007 (Merck Sharp And Dohme LLC A Sub Of Merck And Co Inc). Its 5 listed patents run to March 2032. Generic companies have challenged its patents with the FDA since October 2011.
The first generic of Isentress is expected in September 2029.
Why that month: patent 7,754,731, on the active ingredient, the product’s formulation and a way of using it, ends then. That is about 2.5 years before the last listed patent runs out, in March 2032.
Why a Generic Can Come Before March 2032
The last listed patent runs to March 2032; a court ruling or a settlement can bring a generic sooner. 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.
Isentress Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Isentress’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: patent 7,754,731, which ends in September 2029, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,852,632 | The active ingredient; the product’s formulation; a way of using it (U-257) | January 2028 | Active |
| 7,754,731 Sets the expected month of generic availability | The active ingredient; the product’s formulation; a way of using it (U-257) | September 2029 with the pediatric extension | Active |
| 8,771,733 | The active ingredient; the product’s formulation; a way of using it (U-257) | June 2030 | Active |
| 9,649,311 | The product’s formulation | April 2031 with the pediatric extension | Active |
| 10,772,888 | A way of using it (U-1663) | March 2032 | Active |
Source: FDA Orange Book, application 205786, 203045, 022145. Patent numbers open the patent on Google Patents.
Patent Challenges to Isentress
The first patent challenge to Isentress reached the FDA in October 2011, from one company on that first day. The FDA’s list has 2 entries for Isentress, by form and strength. The FDA approved a first challenger’s generic in December 2024, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Isentress’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 | |||||
| Tablets, 400 mg | October 2011 | 1 company | First challenger eligible decided February 2025 | December 2024 | Not yet | March 2029 |
| Tablets, 600 mg | October 2022 | 1 company | First challenger eligible decided May 2025 | May 2025 | Not yet | March 2032 |
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 Raltegravir Potassium
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 Isentress, but the FDA has already approved 2 companies (step 2), and every approval starts with an application.
Generic companies have challenged Isentress’s patents with the FDA since October 2011: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 2 companies, the first in December 2024. 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 raltegravir potassium is listed for sale by 1 company. Ask your pharmacy whether it can fill your prescription with it.
Camber Pharmaceuticals, Inc.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Hetero Labs Ltd Unit III | December 2024 | EQ 400MG BASE | AB |
| Lupin Ltd | May 2025 | EQ 600MG BASE | AB |
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).
Isentress Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Isentress 400 mg tablet
$34.54 per tablet in October 2026, up 6.8% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Isentress 400 mg tablet $34.54 per tablet
- Isentress hd 600 mg tablet $34.52 per tablet
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $34.54 |
| September 2026 | $34.54 |
| August 2026 | $34.54 |
| July 2026 | $34.54 |
| June 2026 | $34.48 |
| May 2026 | $34.47 |
| April 2026 | $34.56 |
| March 2026 | $34.56 |
| February 2026 | $34.56 |
| January 2026 | $34.56 |
| February 2024 | $32.34 |
| January 2024 | $32.34 |
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 Isentress today: $34.54 per tablet for Isentress 400 mg tablet 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 $34.54 pharmacies pay per tablet 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 Isentress
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 Isentress, before manufacturer rebates.
- $22M
- January to March 2026, the latest CMS has posted
For 3,984 people, about $2,173 per prescription fill - $99.6M
- 2025, the whole year
For 5,586 people, about $2,170 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $22,046,694 | 3,984 | $2,173.37 |
| 2025 | $99,599,316 | 5,586 | $2,170.06 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Isentress only, so no generic is counted in it. What CMS says it is used for: Raltegravir is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better.
Medicaid Prescriptions by Quarter
15,948 prescriptions in the four quarters to Q1 2026, $32.4M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 3,318 | $6,963,676 |
| Q4 2025 | 3,891 | $7,858,168 |
| Q3 2025 | 4,324 | $8,741,664 |
| Q2 2025 | 4,415 | $8,793,623 |
| Q1 2025 | 4,362 | $8,798,941 |
Source: CMS Medicaid State Drug Utilization Data, over Isentress’s own package codes.
Isentress Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 400MG BASE | Tablet | Oral | October 2007 | Prescription reference product |
| EQ 100MG BASE | Tablet, chewable | Oral | December 2011 | Prescription reference product |
| EQ 25MG BASE | Tablet, chewable | Oral | December 2011 | Prescription reference product |
| EQ 100MG BASE/PACKET | Powder | Oral | December 2013 | Prescription reference product |
Source: FDA Orange Book, Merck Sharp And Dohme LLC A Sub Of Merck And Co Inc. Listed for sale today by Merck Sharp & Dohme LLC, A-S Medication Solutions, Direct_Rx, Direct Rx and 5 more (FDA NDC Directory).
Isentress NDC Codes and Packages
Each Isentress 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 |
|---|---|---|---|
| 53002-1686-01 | 400 mg tablet, film coated | bottle of 10 tablets | RPK Pharmaceuticals, Inc. |
| 53002-1686-04 | 400 mg tablet, film coated | bottle of 45 tablets | RPK Pharmaceuticals, Inc. |
| 53002-1686-05 | 400 mg tablet, film coated | bottle of 15 tablets | RPK Pharmaceuticals, Inc. |
| 53002-1686-06 | 400 mg tablet, film coated | bottle of 6 tablets | RPK Pharmaceuticals, Inc. |
| 61919-0706-02 | 400 mg tablet, film coated | bottle of 2 tablets | Direct Rx |
| 61919-0706-04 | 400 mg tablet, film coated | bottle of 4 tablets | Direct Rx |
| 61919-0706-06 | 400 mg tablet, film coated | bottle of 6 tablets | Direct Rx |
| 67296-1235-06 | 400 mg tablet, film coated | bottle of 6 tablets | RedPharm Drug, Inc. |
Show the other 28 Isentress packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 67296-1235-07 | 400 mg tablet, film coated | bottle of 56 tablets | RedPharm Drug, Inc. |
| 67296-1235-08 | 400 mg tablet, film coated | bottle of 8 tablets | RedPharm Drug, Inc. |
| 82982-0055-06 | 400 mg tablet, film coated | bottle of 6 tablets | Pharmasource Meds, LLC |
| 00006-3603-60 | RALTEGRAVIR POTASSIUM 100 mg/1 granule, for suspension | carton of 60 packets of 1 granule | Merck Sharp & Dohme LLC |
| 00006-3603-60 | RALTEGRAVIR POTASSIUM 100 mg/1 granule, for suspension | carton of 60 packets of 1 granule | Merck Sharp & Dohme LLC |
| 00006-3603-61 | RALTEGRAVIR POTASSIUM 100 mg/1 granule, for suspension | carton of 60 packets of 1 granule | Merck Sharp & Dohme LLC |
| 00006-3603-61 | RALTEGRAVIR POTASSIUM 100 mg/1 granule, for suspension | carton of 60 packets of 1 granule | Merck Sharp & Dohme LLC |
| 00006-0477-61 | RALTEGRAVIR POTASSIUM 100 mg/1 tablet, chewable | bottle of 60 tablets | Merck Sharp & Dohme LLC |
| 00006-0477-61 | RALTEGRAVIR POTASSIUM 100 mg/1 tablet, chewable | bottle of 60 tablets | Merck Sharp & Dohme LLC |
| 00006-0473-61 | RALTEGRAVIR POTASSIUM 25 mg/1 tablet, chewable | bottle of 60 tablets | Merck Sharp & Dohme LLC |
| 00006-0473-61 | RALTEGRAVIR POTASSIUM 25 mg/1 tablet, chewable | bottle of 60 tablets | Merck Sharp & Dohme LLC |
| 00006-0227-61 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 60 tablets | Merck Sharp & Dohme LLC |
| 00006-0227-61 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 60 tablets | Merck Sharp & Dohme LLC |
| 50090-1085-00 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 60 tablets | A-S Medication Solutions |
| 50090-1085-00 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 60 tablets | A-S Medication Solutions |
| 68071-2113-06 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 6 tablets | NuCare Pharmaceuticals,Inc. |
| 68071-2113-06 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 6 tablets | NuCare Pharmaceuticals,Inc. |
| 71205-0777-06 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 6 tablets | Proficient Rx LP |
| 71205-0777-14 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 14 tablets | Proficient Rx LP |
| 71205-0777-14 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 14 tablets | Proficient Rx LP |
| 71205-0777-30 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 30 tablets | Proficient Rx LP |
| 71205-0777-30 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 30 tablets | Proficient Rx LP |
| 71205-0777-60 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 60 tablets | Proficient Rx LP |
| 71205-0777-60 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 60 tablets | Proficient Rx LP |
| 71205-0777-90 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 90 tablets | Proficient Rx LP |
| 71205-0777-90 | RALTEGRAVIR POTASSIUM 400 mg/1 tablet, film coated | bottle of 90 tablets | Proficient Rx LP |
| 00006-3080-01 | RALTEGRAVIR POTASSIUM 600 mg/1 tablet, film coated | bottle of 60 tablets | Merck Sharp & Dohme LLC |
| 00006-3080-01 | RALTEGRAVIR POTASSIUM 600 mg/1 tablet, film coated | bottle of 60 tablets | Merck Sharp & Dohme LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Isentress’s own FDA approval (NDA 205786, NDA 203045, NDA 22145) are listed, never a generic. Some codes belong to companies that repackage Isentress: it is the same medicine in a different package.
What a Generic Isentress 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 Isentress
Is there a generic for Isentress right now?
Yes. The FDA NDC Directory lists a generic raltegravir potassium from 1 company. Ask your pharmacy whether it can fill your prescription with it.
When will Isentress go generic?
It already has. The FDA NDC Directory lists a generic raltegravir potassium from 1 company, so ask your pharmacy whether it can fill your prescription with one.
Will generic raltegravir potassium be the same as Isentress?
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 2 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Isentress?
Yes. The FDA Orange Book lists approved generic versions from 2 companies, the first approved in December 2024: Hetero Labs Ltd Unit III and Lupin Ltd. 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 Isentress patent expire?
The FDA Orange Book lists 5 patents for Isentress; the last runs to March 2032. The one behind the expected month is patent 7,754,731, which ends in September 2029. 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 2029) weighs all of that.
Has anyone challenged the Isentress patents?
Yes. The first patent challenge to Isentress reached the FDA in October 2011, from one company on that first day. The FDA approved a first challenger’s generic in December 2024, and the list records no sale by a first challenger 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 Isentress cost now?
Pharmacies paid about $34.54 per tablet for Isentress 400 mg tablet 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 September 2029 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
- PromactaEltrombopag OlamineDuring 2026
- Loreev XRLorazepamJanuary 2034
- FulvestrantFulvestrantMay 2034
- BysantiMilsaperidone2036 to 2037
- ZegfrovySunvozertinibJuly 2039
- TreandaBendamustine HydrochlorideTBD no date yet
About Isentress
- Generic name raltegravir potassium
- How it is taken By mouth
- Company Merck Sharp And Dohme LLC A Sub Of Merck And Co Inc
- Patent challenges Since October 2011 (FDA)
- More drugs Brand-name drugs starting with I
- Have a question? A pharmacist answers, free. Ask about Isentress
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.