Amneal Announces Expanded Coverage for CREXONT® (Carbidopa and Levodopa) to Enhance Access for Parkinson’s Disease Patients in the U.S.

Rhea-AI Summary

Amneal Pharmaceuticals (NASDAQ: AMRX) announced expanded insurance coverage for CREXONT®, its Parkinson's disease treatment, with three major insurers: Veterans Administration, UnitedHealthcare, and CVS Health. This expansion increases total U.S. coverage from 30% to over 50% of covered lives, achieved nine months ahead of their end-2025 target.

CREXONT, FDA-approved in August 2024, combines immediate-release granules with extended-release pellets, making it the longest-lasting oral carbidopa/levodopa formulation available. Clinical trials demonstrated 1.55 more hours of 'Good On' time per dose compared to immediate-release alternatives, representing a 70% increase in symptom control time.

The coverage rollout includes: VA's immediate national formulary addition (covering ~10% of U.S. PD patients), UnitedHealthcare's addition in Q2 2025, and CVS Health's inclusion as a 'preferred' product starting July 1, 2025.

Positive

• Achieved 50% insurance coverage milestone 9 months ahead of schedule
• Secured coverage from three major insurers (VA, UnitedHealthcare, CVS Health)
• Clinical trials showed 70% increase in symptom control time vs traditional treatment
• Added as 'preferred' product on CVS Health formulary

Negative

• Coverage expansion implementation delayed until Q2/Q3 2025 for UnitedHealthcare and CVS Health

Insights

Pharmaceutical Market Access Specialist

Amneal's expanded insurance coverage for CREXONT represents a significant commercial achievement that will directly impact the company's revenue potential for this Parkinson's treatment. Securing formulary placement with the VA, UnitedHealthcare, and CVS Health increases CREXONT's coverage from 30% to over 50% of covered lives - achieving this milestone nine months ahead of their original year-end 2025 target.

The CVS Health "preferred" status is particularly valuable, as it typically results in lower copays and fewer authorization barriers for patients. The VA formulary addition is strategically important given it covers approximately 10% of U.S. Parkinson's patients. These coverage wins create a clear pathway to commercial success for a product that only received FDA approval in August 2024.

From a market access perspective, rapid formulary adoption signals payer recognition of CREXONT's clinical differentiation - specifically its ability to provide 70% more symptom control time per dose compared to standard immediate-release carbidopa/levodopa. This expanded insurance coverage directly addresses the primary barrier to prescription medication adoption in the U.S. healthcare system and significantly accelerates CREXONT's commercial trajectory.

Neurological Treatment Analyst

CREXONT's formulary expansion represents meaningful clinical advancement for Parkinson's disease management. The product addresses a critical unmet need in PD treatment - the "wearing off" phenomenon that affects approximately half of patients within 2-3 years of treatment initiation with standard immediate-release carbidopa/levodopa.

The head-to-head clinical data showing 1.55 more hours of "Good On" time per dose translates to significant quality-of-life improvements for patients. The extended-release technology maintains more stable levodopa levels while maintaining a safety profile consistent with standard therapy (primary adverse events being nausea and anxiety).

This formulation innovation addresses one of the most frustrating aspects of Parkinson's management - the unpredictability of symptom control and frequent dosing requirements with traditional medications. For patients experiencing motor fluctuations, CREXONT's longer duration of action reduces the complex medication scheduling that burdens many patients and caregivers. With major insurers now covering over half of potential patients, this therapeutic option becomes accessible to a substantially larger patient population, potentially establishing CREXONT as a leading option for PD symptom management.

• CREXONT added to 3 large national formularies: Veterans Administration, UnitedHealthcare and CVS Health
• Increases insurance coverage to over 50% of covered lives
• CREXONT was approved by the U.S. FDA to treat Parkinson’s disease in 2024

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that three large insurance coverage accounts, the Veterans Administration (VA), UnitedHealthcare and CVS Health, have added CREXONT^® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD) to their national prescription drug formularies. CREXONT is a prescription medication for the treatment of PD approved by the U.S. FDA in August 2024.

This expanded coverage increases CREXONT’s total U.S. insurance coverage from about 30% of covered lives at the end of 2024 to over 50%. The Company had initially set a goal to surpass 50% coverage by the end of 2025, making this milestone—achieved nine months ahead of schedule—a testament to Amneal’s commitment to broadening patient access. The VA has already added the product in its national formulary, covering approximately 10% of U.S. PD patients. UnitedHealthcare will add CREXONT to its standard prescription drug lists in the second quarter of 2025. In addition, CVS Health will add CREXONT as a “preferred” product to its national formulary on July 1, 2025.

“We are extremely proud to announce the addition of CREXONT on three major insurance platforms,” said Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty at Amneal Pharmaceuticals. “Achieving over 50% coverage within just six months of launch is a significant milestone, demonstrating the immense value CREXONT offers PD patients and our continued commitment to ensuring patient access.”

CREXONT’s therapeutic benefits include:

• Novel formulation designed to provide long lasting efficacy: CREXONT is an innovative formulation of carbidopa/levodopa (CD/LD) that combines immediate-release (IR) granules for rapid onset of action and extended-release pellets with a novel technology, designed to target the area of absorption, making CREXONT the longest-lasting oral CD/LD formulation available today. The novel technology delivers more stable levodopa levels that do not wear off as quickly or as often as traditional IR formulation. Over time with IR CD/LD therapy, the duration of symptom control may become more unpredictable, and patients may experience more “Off” time. About half of patients taking a PD medication may experience “Off” episodes – time where their motor symptoms return or are not well-controlled – within 2 to 3 years of treatment initiation.¹
• More “Good On” time with less frequent dosing: A head-to-head clinical trial showed CREXONT provides more “Good On” time per day, and 1.55 more hours of “Good On” time per dose (where symptoms are well-controlled without troublesome involuntary movements) compared to IR CD/LD. This represents a 70% increase in the amount of time each dose helps people feel in control of their PD symptoms.
• Safety profile consistent with IR CD/LD: The most common adverse reactions with CREXONT (incidence ≥3% and greater than IR CD/LD) are nausea and anxiety. See Important Safety Information below.

To further support patients, providers, and care partners as they navigate insurance coverage and their treatment on CREXONT, Amneal offers a full suite of services and support within the Amneal Patient Support Program. For more information, visit https://crexont.com/support-resources/ or call 1-877-764-9021 Monday-Friday 8:00AM-5:00PM CST for live support.

About CREXONT^®
CREXONT is an innovative formulation consisting of immediate-release granules with carbidopa and levodopa for rapid onset of action, and extended-release pellets with levodopa for long-lasting efficacy. CREXONT formulation and dosage strengths are different from RYTARY^® (carbidopa and levodopa) extended-release capsules approved by the U.S. FDA in 2015. Learn more about CREXONT at crexont.com.

INDICATION
CREXONT (carbidopa and levodopa) extended-release capsules is a prescription medication for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults.

IMPORTANT SAFETY INFORMATION

• Do not take CREXONT with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors.
• Do not take CREXONT with other carbidopa-levodopa preparations without consulting your healthcare provider.
• CREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. Avoid activities that require alertness such as driving and operating machinery, until you know how CREXONT affects you.
• The most common side effects that may occur with CREXONT are nausea and anxiety.
• Avoid sudden discontinuation or rapid dose reduction with CREXONT. If you are discontinuing CREXONT, work with your healthcare provider to taper the dose over time to reduce the risk of fever or confusion.
• You may take CREXONT with or without food; but taking it with food may decrease or delay its effect. Consider taking the first dose of the day about 1 to 2 hours before eating.
• Swallow CREXONT whole. Do not chew, divide, or crush the capsules.
• Do not take CREXONT with alcohol.

Tell your healthcare provider if you:

• Have any heart conditions, especially if you have had a heart attack or irregular heartbeats.
• Experience hallucinations or abnormal thoughts and behaviors.
• Have an inability to control urges to gamble, have increased sexual urges, or experience other intense urges.
• Have thoughts of suicide or have attempted suicide.
• Have abnormal involuntary movements that appear or get worse during treatment.
• Have ever had a peptic ulcer or glaucoma.
• Become or intend to become pregnant. Based on animal data, CREXONT may cause fetal harm.
• Are breastfeeding during therapy.
• Have side effects; your doctor can adjust your dose.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals, LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the full Prescribing Information. For more information talk to your healthcare provider.

About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.

Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

References:

(1) Stocchi F et al. Parkinsonism Relat Disord. 2014;20(2):204-211.

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Investor Contact

Anthony DiMeo

VP, Investor Relations

anthony.dimeo@amneal.com

Media Contact

Randi Kahn

SVP, Corporate Affairs, Syneos Health

randi.kahn@syneoshealth.com

Amneal Medical Affairs

888-990-AMRX (2679)

askamrx@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What is the new insurance coverage percentage for Amneal's CREXONT (AMRX) after recent expansions?

CREXONT's insurance coverage increased from 30% to over 50% of covered lives in the U.S., following addition to VA, UnitedHealthcare, and CVS Health formularies.

How much additional 'Good On' time does CREXONT provide compared to traditional Parkinson's medications?

CREXONT provides 1.55 more hours of 'Good On' time per dose, a 70% increase in symptom control time compared to immediate-release carbidopa/levodopa.

When will UnitedHealthcare and CVS Health begin covering CREXONT (AMRX)?

UnitedHealthcare will add CREXONT in Q2 2025, while CVS Health will include it as a preferred product starting July 1, 2025.

What are the main side effects reported for CREXONT in Parkinson's treatment?

The most common adverse reactions (≥3% and greater than IR CD/LD) are nausea and anxiety.