Absorica LD Generic: When Will Generic Isotretinoin 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
Absorica LD Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2035 About 8.5 years away Why then?
- Has the FDA approved a generic? November 2002 8 companies approved
- When does the last patent end? August 2035 2 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 15 companies list one
It already is. A generic isotretinoin is listed for sale by 15 companies, so ask your pharmacy whether it can fill your prescription with one.
Why May 2035?
It is when Absorica LD’s patent 9,750,711 ends. That patent covers the product’s formulation, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Absorica LD’s last patent runs to August 2035, how can a generic come sooner?
The patent that runs to August 2035 (9,700,535) covers the product’s formulation. 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. 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 Absorica LD, 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.
Absorica LD 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
- None filed yet No filers on record
- Brand sales
- $17M a yearSmaller seller
- FDA approved 2019 November 2019 FDA Orange Book
- Patents listed 2 last runs to August 2035 FDA Orange Book
- Generics FDA-approved 8 companies, the first approved November 2002 FDA Orange Book
- Pharmacies pay $38.41 per capsule NADAC, October 2026
- Medicare Part D spent $38.9K in 2025 CMS Part D Spending by Drug
- Medicaid prescriptions 1,279 in the last four reported quarters, $2.6M CMS Medicaid drug utilization, to Q1 2026
Absorica LD’s Road to a Generic
Absorica LD has had the market to itself since the FDA approved it in November 2019 (Sun Pharmaceutical Industries Ltd). Its 2 listed patents run to August 2035.
The first generic of Absorica LD is expected in May 2035.
Why that month: patent 9,750,711, on the product’s formulation, ends then. That is a few months before the last listed patent runs out, in August 2035.
Why a Generic Can Come Before August 2035
The last listed patent runs to August 2035, but it covers the product’s formulation, 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.
Absorica LD Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Absorica LD’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 9,750,711, which ends in May 2035, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,750,711 Sets the expected month of generic availability | The product’s formulation | May 2035 | Active |
| 9,700,535 | The product’s formulation | August 2035 | Active |
Source: FDA Orange Book, application 211913. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Isotretinoin
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 Absorica LD, but the FDA has already approved 8 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 8 companies, the first in November 2002. 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 isotretinoin is listed for sale by 15 companies. Ask your pharmacy whether it can fill your prescription with it.
Actavis Pharma, Inc., Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals NY LLC, Aurobindo Pharma Limited, BluePoint Laboratories, Dr. Reddy's Laboratories Limited and 9 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Mylan Pharmaceuticals Inc | November 2002 | 10MG, 20MG, 30MG, 40MG | AB1 |
| Teva Pharmaceuticals USA | April 2003 | 10MG, 20MG, 30MG, 40MG | AB1 |
| Upsher Smith Laboratories LLC | January 2012 | 10MG, 20MG, 30MG, 40MG | AB2, AB1 |
| Dr Reddys Laboratories Ltd | March 2013 | 10MG, 20MG, 30MG, 40MG | AB1 |
| Amneal Pharmaceuticals Of Ny LLC | September 2017 | 10MG, 20MG, 25MG, 30MG, 35MG, 40MG | AB1 |
| Actavis Laboratories Fl Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals USA Inc | March 2021 | 10MG, 20MG, 25MG, 30MG, 35MG, 40MG | AB2 |
| Zydus Pharmaceuticals USA Inc | August 2023 | 10MG, 20MG, 25MG, 30MG, 35MG, 40MG | AB1, AB2 |
| Aurobindo Pharma Ltd | January 2024 | 10MG, 20MG, 25MG, 30MG, 35MG, 40MG | AB2, AB1 |
| Sun Pharmaceutical Industries Ltd discontinued | December 2002 | 10MG, 20MG, 30MG, 40MG | – |
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).
Absorica LD Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Absorica ld 16 mg capsule
$38.41 per capsule in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
- Absorica ld 16 mg capsule $38.41 per capsule
- Absorica ld 24 mg capsule $42.23 per capsule
- Absorica ld 32 mg capsule $42.42 per capsule
See the numbers
| Month | Pharmacies paid per capsule |
|---|---|
| October 2026 | $38.41 |
| September 2026 | $38.41 |
| August 2026 | $38.41 |
| July 2026 | $38.41 |
| June 2026 | $38.41 |
| May 2026 | $38.41 |
| April 2026 | $38.41 |
| March 2026 | $38.41 |
| February 2026 | $38.41 |
| January 2026 | $38.41 |
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 Absorica LD today: $38.41 per capsule for Absorica ld 16 mg capsule 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 $38.41 pharmacies pay per capsule 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 Absorica LD
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 Absorica LD, before manufacturer rebates.
- $38.9K
- 2025, the whole year
About $1,947 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| 2025 | $38,949 | – | $1,947.43 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Absorica LD only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (such as benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). It belongs to a class of drugs known as retinoids.
Medicaid Prescriptions by Quarter
1,279 prescriptions in the four quarters to Q1 2026, $2.6M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 240 | $489,350 |
| Q4 2025 | 293 | $582,696 |
| Q3 2025 | 378 | $764,697 |
| Q2 2025 | 368 | $775,616 |
| Q1 2025 | 441 | $910,559 |
Source: CMS Medicaid State Drug Utilization Data, over Absorica LD’s own package codes.
Absorica LD Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 16MG | Capsule | Oral | November 2019 | Prescription reference product |
| 24MG | Capsule | Oral | November 2019 | Prescription reference product |
| 32MG | Capsule | Oral | November 2019 | Prescription reference product |
| 8MG | Capsule | Oral | November 2019 | Prescription reference product |
| 20MG | Capsule | Oral | November 2019 | Discontinued reference product |
| 28MG | Capsule | Oral | November 2019 | Discontinued reference product |
Source: FDA Orange Book, Sun Pharmaceutical Industries Ltd. Listed for sale today by Sun Pharmaceutical Industries, Inc. (FDA NDC Directory).
Absorica LD NDC Codes and Packages
Each Absorica LD 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 |
|---|---|---|---|
| 10631-0003-31 | ISOTRETINOIN 16 mg/1 capsule | box of 3 blister packs of 10 capsules | Sun Pharmaceutical Industries, Inc. |
| 10631-0003-31 | ISOTRETINOIN 16 mg/1 capsule | box of 3 blister packs of 10 capsules | Sun Pharmaceutical Industries, Inc. |
| 10631-0005-31 | ISOTRETINOIN 24 mg/1 capsule | box of 3 blister packs of 10 capsules | Sun Pharmaceutical Industries, Inc. |
| 10631-0005-31 | ISOTRETINOIN 24 mg/1 capsule | box of 3 blister packs of 10 capsules | Sun Pharmaceutical Industries, Inc. |
| 10631-0007-31 | ISOTRETINOIN 32 mg/1 capsule | box of 3 blister packs of 10 capsules | Sun Pharmaceutical Industries, Inc. |
| 10631-0007-31 | ISOTRETINOIN 32 mg/1 capsule | box of 3 blister packs of 10 capsules | Sun Pharmaceutical Industries, Inc. |
| 10631-0002-31 | ISOTRETINOIN 8 mg/1 capsule | box of 3 blister packs of 10 capsules | Sun Pharmaceutical Industries, Inc. |
| 10631-0002-31 | ISOTRETINOIN 8 mg/1 capsule | box of 3 blister packs of 10 capsules | Sun Pharmaceutical Industries, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Absorica LD’s own FDA approval (NDA 211913) are listed, never a generic. Some codes belong to companies that repackage Absorica LD: it is the same medicine in a different package.
What a Generic Absorica LD 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 Absorica LD
Is there a generic for Absorica LD right now?
Yes. The FDA NDC Directory lists a generic isotretinoin from 15 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Absorica LD go generic?
It already has. The FDA NDC Directory lists a generic isotretinoin from 15 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic isotretinoin be the same as Absorica LD?
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 8 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Absorica LD?
Yes. The FDA Orange Book lists approved generic versions from 8 companies, the first approved in November 2002: Mylan Pharmaceuticals Inc, Teva Pharmaceuticals USA, Upsher Smith Laboratories LLC, Dr Reddys Laboratories Ltd and 4 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 Absorica LD patent expire?
The FDA Orange Book lists 2 patents for Absorica LD; the last runs to August 2035. The one behind the expected month is patent 9,750,711, which ends in May 2035. 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 (May 2035) weighs all of that.
How much does Absorica LD cost now?
Pharmacies paid about $38.41 per capsule for Absorica ld 16 mg capsule 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 May 2035 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
- BeleodaqBelinostat2026 to 2027
- ExondysEteplirsenFebruary 2029
- OzempicSemaglutide2031 to 2032
- XeravaEravacycline DihydrochlorideAugust 2032
- TabrectaCapmatinib HydrochlorideNovember 2032
- KynmobiApomorphine HydrochlorideApril 2036
About Absorica LD
- Generic name isotretinoin
- How it is taken By mouth
- Company Sun Pharmaceutical Industries Ltd
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with A
- Have a question? A pharmacist answers, free. Ask about Absorica LD
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), 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.