Crexont Generic: When Will Generic Carbidopa and Levodopa 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
Crexont Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2035 to 2038 A wide window Why then?
- Has the FDA approved a generic? August 1992 13 companies approved
- When does the last patent end? December 2041 30 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 41 companies list one
It already is. A generic carbidopa and levodopa is listed for sale by 41 companies, so ask your pharmacy whether it can fill your prescription with one.
Why 2035 to 2038?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it probable: more likely than not, but it can still move.
If Crexont’s last patent runs to December 2041, how can a generic come sooner?
The 13 patents that run past the expected month, to December 2041 (11,986,449, 12,109,185, 12,194,150, 12,201,596 and 9 more), cover a way of using it. 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. Here, the companies are expected to settle on a date. Generic companies have been challenging Crexont’s patents with the FDA since September 2024. 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 Crexont, 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.
Crexont by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Moderate 2 companies have filed, 1 first in line
- Brand sales
- $110M a yearBig seller
- FDA approved 2024 August 2024 FDA Orange Book
- Patents listed 30 last runs to December 2041 FDA Orange Book
- Generics FDA-approved 13 companies, the first approved August 1992 FDA Orange Book
- Pharmacies pay $4.59 per capsule NADAC, October 2026
- Medicare Part D spent $55.1M in 2025, for 15.9K people CMS Part D Spending by Drug
- Medicaid prescriptions 1,615 in the last four reported quarters, $1M CMS Medicaid drug utilization, to Q1 2026
Crexont’s Road to a Generic
Crexont has had the market to itself since the FDA approved it in August 2024 (Impax Laboratories LLC). Its FDA protection (new product) runs to August 2027. Its 30 listed patents run to December 2041. Generic companies have challenged its patents with the FDA since September 2024.
The first generic of Crexont is expected between 2035 and 2038.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Why a Generic Can Come Before December 2041
The last listed patent runs to December 2041, but it covers a way of using it, 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.
Crexont Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Crexont’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 |
|---|---|---|---|
| 10,098,845 | The product’s formulation; a way of using it (U-219) | October 2034 | Active |
| 10,292,935 | The product’s formulation; a way of using it (U-219) | October 2034 | Active |
| 10,688,058 | The product’s formulation; a way of using it (U-219) | October 2034 | Active |
| 10,973,769 | The product’s formulation; a way of using it (U-219) | October 2034 | Active |
| 10,987,313 | The product’s formulation; a way of using it (U-219) | October 2034 | Active |
| 11,357,733 | The product’s formulation | October 2034 | Active |
| 11,622,941 | The product’s formulation | October 2034 | Active |
| 11,666,538 | The product’s formulation; a way of using it (U-219) | October 2034 | Active |
| 12,064,521 | The product’s formulation | October 2034 | Active |
| 12,128,141 | The product’s formulation; a way of using it (U-219) | October 2034 | Active |
| 12,178,918 | The product’s formulation | October 2034 | Active |
| 12,178,919 | The product’s formulation; a way of using it (U-219) | October 2034 | Active |
| 12,274,793 | The product’s formulation | October 2034 | Active |
| 12,303,605 | The product’s formulation | October 2034 | Active |
| 12,403,099 | The product’s formulation | October 2034 | Active |
| 12,491,164 | The product’s formulation | October 2034 | Active |
| 12,691,074 | The product’s formulation | October 2034 | Active |
| 11,986,449 | A way of using it (U-219) | December 2041 | Active |
| 12,109,185 | A way of using it (U-1649, U-219, U-4004, U-4005) | December 2041 | Active |
| 12,194,150 | A way of using it (U-219) | December 2041 | Active |
| 12,201,596 | A way of using it (U-1649, U-4004, U-4005) | December 2041 | Active |
| 12,263,148 | A way of using it (U-1649, U-4004, U-219, U-4005) | December 2041 | Active |
| 12,263,149 | A way of using it (U-1649, U-219, U-4004, U-4005) | December 2041 | Active |
| 12,295,931 | A way of using it (U-1649, U-4005, U-4004, U-219) | December 2041 | Active |
| 12,303,481 | A way of using it (U-1649, U-219, U-4004, U-4005) | December 2041 | Active |
| 12,303,482 | A way of using it (U-1649, U-4005, U-4004, U-219) | December 2041 | Active |
| 12,370,163 | A way of using it (U-1649, U-219, U-4004, U-4005) | December 2041 | Active |
| 12,447,139 | A way of using it (U-1649, U-219, U-4004, U-4005) | December 2041 | Active |
| 12,453,710 | A way of using it (U-4005, U-4004, U-219, U-1649) | December 2041 | Active |
| 12,458,616 | A way of using it (U-1649, U-4005, U-4004, U-219) | December 2041 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | August 2027 | Active |
Source: FDA Orange Book, application 217186. Patent numbers open the patent on Google Patents.
Patent Challenges to Crexont
The first patent challenge to Crexont reached the FDA in September 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 Crexont’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 | |||||
| Extended-release capsules, 35 mg/140 mg 52.5 mg/210 mg 70 mg/280 mg 87.5 mg/350 mg | September 2024 | 1 company | No decision yet | Not yet | Not yet | December 2041 |
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 Carbidopa and Levodopa
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
At least 14 companies have applied to the FDA to make generic carbidopa and levodopa.
The FDA has tentatively approved one company’s generic: Sandoz Inc (March 2023). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
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 Crexont’s patents with the FDA since September 2024: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 13 companies, the first in August 1992. 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 carbidopa and levodopa is listed for sale by 41 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Accord Healthcare, Inc., Actavis Pharma, Inc., Advagen Pharma Ltd, Advagen Pharma Ltd.,, Alembic Pharmaceuticals Inc. and 34 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Dr Reddys Laboratories SA | August 1992 | 10MG;100MG, 25MG;100MG, 25MG;250MG | AB |
| Actavis Elizabeth LLC | September 1993 | 10MG;100MG, 25MG;100MG, 25MG;250MG | AB |
| Mylan Pharmaceuticals Inc | September 1999 | 25MG;100MG, 50MG;200MG | AB |
| Impax Laboratories Inc | May 2004 | 10MG;100MG, 25MG;100MG, 25MG;250MG, 50MG;200MG | AB |
| Sun Pharmaceutical Industries Ltd | August 2007 | 10MG;100MG, 25MG;100MG, 25MG;250MG, 50MG;200MG | AB |
| Rising Pharma Holding Inc | September 2008 | 10MG;100MG, 25MG;100MG, 25MG;250MG | AB |
| Pharmobedient Consulting LLC | September 2009 | 10MG;100MG, 25MG;100MG, 25MG;250MG | AB |
| Accord Healthcare Inc | February 2013 | 25MG;100MG, 50MG;200MG | AB |
| Alembic Pharmaceuticals Ltd | June 2019 | 25MG;100MG, 50MG;200MG | AB |
| Sciegen Pharmaceuticals Inc | May 2021 | 10MG;100MG, 25MG;100MG, 25MG;250MG, 50MG;200MG | AB |
| Rubicon Research Ltd | September 2022 | 10MG;100MG, 25MG;100MG, 25MG;250MG, 50MG;200MG | AB |
| Aurobindo Pharma Ltd | November 2022 | 10MG;100MG, 25MG;100MG, 25MG;250MG | AB |
| Ascent Pharmaceuticals Inc | January 2025 | 10MG;100MG, 25MG;100MG, 25MG;250MG | AB |
| Watson Laboratories Inc discontinued | September 1993 | 10MG;100MG, 25MG;100MG, 25MG;250MG | – |
| Scs Pharmaceuticals discontinued | March 1994 | 10MG;100MG, 25MG;100MG, 25MG;250MG | – |
| Ani Pharmaceuticals Inc discontinued | June 1995 | 10MG;100MG, 25MG;100MG, 25MG;250MG | – |
| Apotex Inc discontinued | June 2004 | 10MG;100MG, 25MG;100MG, 25MG;250MG, 50MG;200MG | – |
| Kv Pharmaceutical Co discontinued | June 2004 | 50MG;200MG | – |
| Ucb Inc discontinued | August 2004 | 10MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | – |
| Ranbaxy Laboratories Ltd discontinued | June 2005 | 10MG;100MG, 25MG;100MG, 25MG;250MG | – |
| Zydus Pharmaceuticals USA Inc discontinued | April 2023 | 10MG;100MG, 25MG;100MG, 25MG;250MG | – |
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).
Crexont Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Crexont ER 35 mg-140 mg cap
$4.59 per capsule in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
- Crexont ER 35 mg-140 mg cap $4.59 per capsule
- Crexont ER 52.5 mg-210 mg cap $4.58 per capsule
- Crexont ER 70 mg-280 mg cap $4.58 per capsule
- Crexont ER 87.5 mg-350 mg cap $4.58 per capsule
See the numbers
| Month | Pharmacies paid per capsule |
|---|---|
| October 2026 | $4.59 |
| September 2026 | $4.59 |
| August 2026 | $4.59 |
| July 2026 | $4.59 |
| June 2026 | $4.37 |
| May 2026 | $4.37 |
| April 2026 | $4.37 |
| March 2026 | $4.37 |
| February 2026 | $4.37 |
| January 2026 | $4.37 |
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 Crexont today: $4.59 per capsule for Crexont ER 35 mg-140 mg cap 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). Crexont has 14 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $4.59 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 Crexont
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 Crexont, before manufacturer rebates.
- $23M
- January to March 2026, the latest CMS has posted
For 14,121 people, about $768 per prescription fill - $55.1M
- 2025, the whole year
For 15,860 people, about $807 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $23,045,477 | 14,121 | $768.39 |
| 2025 | $55,085,631 | 15,860 | $807.42 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Crexont only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat the symptoms of Parkinson's disease (such as shakiness, stiffness, difficulty moving) or Parkinson-like conditions. Parkinson's disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain.
Medicaid Prescriptions by Quarter
1,615 prescriptions in the four quarters to Q1 2026, $1M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 376 | $237,478 |
| Q4 2025 | 532 | $334,843 |
| Q3 2025 | 464 | $290,416 |
| Q2 2025 | 243 | $139,267 |
| Q1 2025 | 164 | $112,746 |
Source: CMS Medicaid State Drug Utilization Data, over Crexont’s own package codes.
Crexont Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 35MG;140MG | Capsule, extended release | Oral | August 2024 | Prescription reference product |
| 52.5MG;210MG | Capsule, extended release | Oral | August 2024 | Prescription reference product |
| 70MG;280MG | Capsule, extended release | Oral | August 2024 | Prescription reference product |
| 87.5MG;350MG | Capsule, extended release | Oral | August 2024 | Prescription reference product |
Source: FDA Orange Book, Impax Laboratories LLC. Listed for sale today by Amneal Pharmaceuticals LLC (FDA NDC Directory).
Crexont NDC Codes and Packages
Each Crexont 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 |
|---|---|---|---|
| 64896-0967-16 | CARBIDOPA HYDRATE 35 mg/1 / LEVODOPA 140 mg/1 capsule, extended release | bottle of 120 capsules | Amneal Pharmaceuticals LLC |
| 64896-0967-23 | CARBIDOPA HYDRATE 35 mg/1 / LEVODOPA 140 mg/1 capsule, extended release | bottle of 120 capsules | Amneal Pharmaceuticals LLC |
| 64896-0968-16 | CARBIDOPA HYDRATE 52.5 mg/1 / LEVODOPA 210 mg/1 capsule, extended release | bottle of 120 capsules | Amneal Pharmaceuticals LLC |
| 64896-0968-23 | CARBIDOPA HYDRATE 52.5 mg/1 / LEVODOPA 210 mg/1 capsule, extended release | bottle of 120 capsules | Amneal Pharmaceuticals LLC |
| 64896-0969-16 | CARBIDOPA HYDRATE 70 mg/1 / LEVODOPA 280 mg/1 capsule, extended release | bottle of 120 capsules | Amneal Pharmaceuticals LLC |
| 64896-0969-23 | CARBIDOPA HYDRATE 70 mg/1 / LEVODOPA 280 mg/1 capsule, extended release | bottle of 120 capsules | Amneal Pharmaceuticals LLC |
| 64896-0970-16 | CARBIDOPA HYDRATE 87.5 mg/1 / LEVODOPA 350 mg/1 capsule, extended release | bottle of 120 capsules | Amneal Pharmaceuticals LLC |
| 64896-0970-23 | CARBIDOPA HYDRATE 87.5 mg/1 / LEVODOPA 350 mg/1 capsule, extended release | bottle of 120 capsules | Amneal Pharmaceuticals LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Crexont’s own FDA approval (NDA 217186) are listed, never a generic. Some codes belong to companies that repackage Crexont: it is the same medicine in a different package.
What a Generic Crexont 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 Crexont
Is there a generic for Crexont right now?
Yes. The FDA NDC Directory lists a generic carbidopa and levodopa from 41 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Crexont go generic?
It already has. The FDA NDC Directory lists a generic carbidopa and levodopa from 41 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic carbidopa and levodopa be the same as Crexont?
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. At least 14 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $4.59 pharmacies pay per capsule for Crexont today to under $0.23. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Crexont?
Yes. The FDA Orange Book lists approved generic versions from 13 companies, the first approved in August 1992: Dr Reddys Laboratories SA, Actavis Elizabeth LLC, Mylan Pharmaceuticals Inc, Impax Laboratories Inc and 9 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 Crexont patent expire?
The FDA Orange Book lists 30 patents for Crexont; the last runs to December 2041. 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 (2035 to 2038) weighs all of that.
Has anyone challenged the Crexont patents?
Yes. The first patent challenge to Crexont reached the FDA in September 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.
How much does Crexont cost now?
Pharmacies paid about $4.59 per capsule for Crexont ER 35 mg-140 mg cap 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 2035 to 2038 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
- KovanazeOxymetazoline Hydrochloride and Tetracaine HydrochlorideApril 2030
- Otezla XRApremilast2031 to 2032
- SymproicNaldemedine TosylateFebruary 2031
- XatmepMethotrexate SodiumJanuary 2033
- EskataHydrogen PeroxideApril 2035
- BalversaErdafitinibDuring 2037
About Crexont
- Generic name carbidopa and levodopa
- How it is taken By mouth
- Company Impax Laboratories LLC
- Patent challenges Since September 2024 (FDA)
- More drugs Brand-name drugs starting with C
- Have a question? A pharmacist answers, free. Ask about Crexont
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.