Dhivy Generic: When Will Generic Carbidopa and Levodopa Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Dhivy Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? March 2039 About 12.5 years away Why then?
  2. Has the FDA approved a generic? August 1992 13 companies approved
  3. When does the last patent end? March 2039 3 patents listed with the FDA
  4. Can you buy a generic today? Yes 41 companies list one

Explains

PharmD, BCPS · Clinical pharmacist Updated

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 March 2039?

It is when Dhivy’s patents 11,033,521, 11,439,613 and 11,819,485 end. They cover the product’s formulation and 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.

What should I do now?

Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Dhivy, 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.

Dhivy 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
$2M a yearSmaller seller
  • FDA approved 2021 November 2021 FDA Orange Book
  • Patents listed 3 last runs to March 2039 FDA Orange Book
  • Generics FDA-approved 13 companies, the first approved August 1992 FDA Orange Book
  • Pharmacies pay $3.61 per tablet NADAC, October 2026
  • Medicare Part D spent $984.8K in 2025, for 420 people CMS Part D Spending by Drug
  • Medicaid prescriptions 22 in the last four reported quarters, $10.3K CMS Medicaid drug utilization, to Q4 2025

Dhivy’s Road to a Generic

Dhivy has had the market to itself since the FDA approved it in November 2021 (Avion Pharmaceuticals LLC). Its 3 listed patents run to March 2039.

The first generic of Dhivy is expected in March 2039.

Why that month: patents 11,033,521, 11,439,613 and 11,819,485, on the product’s formulation and a way of using it, end then.

Brand alone on the market Since FDA approval, November 2021
Patent 11,033,521 Expires March 2039 The patent behind the expected month of generic availability
Patent 11,439,613 Expires March 2039 The patent behind the expected month of generic availability
Patent 11,819,485 Expires March 2039 The patent behind the expected month of generic availability
Brand alone on the market Patent on the formulation Patent on a use First generic expected Swipe the chart sideways to see every year.

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.

Dhivy Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Dhivy’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 11,033,521, 11,439,613 and 11,819,485, which end in March 2039, the month the first generic is expected.

Patents listed with the FDA (3)
PatentWhat it coversProtects untilStatus
11,033,521 Sets the expected month of generic availability The product’s formulation; a way of using it (U-219, U-3304, U-3305) March 2039 Active
11,439,613 Sets the expected month of generic availability A way of using it (U-3557) March 2039 Active
11,819,485 Sets the expected month of generic availability A way of using it (U-3557) March 2039 Active

Source: FDA Orange Book, application 214869. Patent numbers open the patent on Google Patents.

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.

1

Applied to the FDA

No application count is on record for Dhivy, but the FDA has already approved 13 companies (step 2), and every approval starts with an application.

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.

2

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.

3

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

Generic versions the FDA has approved (21 companies)
CompanyFirst approvedStrengthsRated
Dr Reddys Laboratories SA August 199210MG;100MG, 25MG;100MG, 25MG;250MGAB
Actavis Elizabeth LLC September 199310MG;100MG, 25MG;100MG, 25MG;250MGAB
Mylan Pharmaceuticals Inc September 199925MG;100MG, 50MG;200MGAB
Impax Laboratories Inc May 200410MG;100MG, 25MG;100MG, 25MG;250MG, 50MG;200MGAB
Sun Pharmaceutical Industries Ltd August 200710MG;100MG, 25MG;100MG, 25MG;250MG, 50MG;200MGAB
Rising Pharma Holding Inc September 200810MG;100MG, 25MG;100MG, 25MG;250MGAB
Pharmobedient Consulting LLC September 200910MG;100MG, 25MG;100MG, 25MG;250MGAB
Accord Healthcare Inc February 201325MG;100MG, 50MG;200MGAB
Alembic Pharmaceuticals Ltd June 201925MG;100MG, 50MG;200MGAB
Sciegen Pharmaceuticals Inc May 202110MG;100MG, 25MG;100MG, 25MG;250MG, 50MG;200MGAB
Rubicon Research Ltd September 202210MG;100MG, 25MG;100MG, 25MG;250MG, 50MG;200MGAB
Aurobindo Pharma Ltd November 202210MG;100MG, 25MG;100MG, 25MG;250MGAB
Ascent Pharmaceuticals Inc January 202510MG;100MG, 25MG;100MG, 25MG;250MGAB
Watson Laboratories Inc discontinued September 199310MG;100MG, 25MG;100MG, 25MG;250MG–
Scs Pharmaceuticals discontinued March 199410MG;100MG, 25MG;100MG, 25MG;250MG–
Ani Pharmaceuticals Inc discontinued June 199510MG;100MG, 25MG;100MG, 25MG;250MG–
Apotex Inc discontinued June 200410MG;100MG, 25MG;100MG, 25MG;250MG, 50MG;200MG–
Kv Pharmaceutical Co discontinued June 200450MG;200MG–
Ucb Inc discontinued August 200410MG;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 200510MG;100MG, 25MG;100MG, 25MG;250MG–
Zydus Pharmaceuticals USA Inc discontinued April 202310MG;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).

Dhivy Price: What Pharmacies Pay and What Generics Usually Do

What Pharmacies Pay for Dhivy 25-100 mg tablet

$3.61 per tablet in October 2026.

Hover over or tap anywhere on the chart to see that month’s price.

See the numbers
MonthPharmacies paid per tablet
October 2026$3.61
September 2026$3.61
August 2026$3.61
July 2026$3.61
June 2026$3.61
May 2026$3.61
April 2026$3.61
March 2026$3.61
February 2026$3.61
January 2026$3.61

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 Dhivy today: $3.61 per tablet for Dhivy 25-100 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 $3.61 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 Dhivy

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 Dhivy, before manufacturer rebates.

$238.7K
January to March 2026, the latest CMS has posted
For 238 people, about $628 per prescription fill
$984.8K
2025, the whole year
For 420 people, about $612 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$238,668238$628.07
2025$984,771420$612.04

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Dhivy only, so no generic is counted in it. What CMS says it is used for: This combination medication is used to treat symptoms of Parkinson's disease or Parkinson-like symptoms (such as shakiness, stiffness, difficulty moving). Parkinson's disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain.

Medicaid Prescriptions by Quarter

22 prescriptions in the four quarters to Q4 2025, $10.3K paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q4 202511$3,657
Q3 20250$0
Q2 202511$6,680
Q1 20250$0

Source: CMS Medicaid State Drug Utilization Data, over Dhivy’s own package codes.

Dhivy Strengths and Forms

StrengthFormHow it is takenApprovedStatus
25MG;100MGTabletOralNovember 2021Prescription reference product

Source: FDA Orange Book, Avion Pharmaceuticals LLC. Listed for sale today by Avion Pharmaceuticals, LLC (FDA NDC Directory).

Dhivy NDC Codes and Packages

Each Dhivy 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.

Dhivy packages (2)
NDCProductPackageCompany
75854-0701-01CARBIDOPA HYDRATE 25 mg/1 / LEVODOPA 100 mg/1 tabletbottle of 100 tabletsAvion Pharmaceuticals, LLC
75854-0701-01CARBIDOPA HYDRATE 25 mg/1 / LEVODOPA 100 mg/1 tabletbottle of 100 tabletsAvion Pharmaceuticals, LLC

Source: the FDA NDC Directory, current listings only. Only packages sold under Dhivy’s own FDA approval (NDA 214869) are listed, never a generic. Some codes belong to companies that repackage Dhivy: it is the same medicine in a different package.

What a Generic Dhivy 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 Dhivy

Is there a generic for Dhivy 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 Dhivy 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 Dhivy?

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 13 companies to make a generic, and how many of them launch decides how far the price falls.

Has the FDA approved a generic Dhivy?

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 Dhivy patent expire?

The FDA Orange Book lists 3 patents for Dhivy; the last runs to March 2039. The one behind the expected month is patents 11,033,521, 11,439,613 and 11,819,485, which end in March 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 (March 2039) weighs all of that.

How much does Dhivy cost now?

Pharmacies paid about $3.61 per tablet for Dhivy 25-100 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 March 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

All upcoming generics

About Dhivy

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.