CREXONT Drug Patent Profile

When do Crexont patents expire, and when can generic versions of Crexont launch?

Crexont is a drug marketed by Impax and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in thirteen countries.

The generic ingredient in CREXONT is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Crexont

A generic version of CREXONT was approved as carbidopa; levodopa by DR REDDYS LABS SA on August 28^th, 1992.

Summary for CREXONT

International Patents:	32
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in CREXONT?	CREXONT excipients list
DailyMed Link:	CREXONT at DailyMed

Pharmacology for CREXONT

Drug Class

Aromatic Amino Acid

Paragraph IV (Patent) Challenges for CREXONT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CREXONT	Extended-release Capsules	carbidopa; levodopa	35 mg/140 mg 52.5 mg/210 mg 70 mg/280 mg 87.5 mg/350 mg	217186	1	2024-09-23

US Patents and Regulatory Information for CREXONT

CREXONT is protected by twenty-one US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-002	Aug 7, 2024		RX	Yes	No	12,064,521		Y
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-003	Aug 7, 2024		RX	Yes	No	10,688,058		Y
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-003	Aug 7, 2024		RX	Yes	No	12,194,150
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-003	Aug 7, 2024		RX	Yes	No	11,986,449
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-003	Aug 7, 2024		RX	Yes	No	10,292,935		Y
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-004	Aug 7, 2024		RX	Yes	Yes	10,292,935		Y
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-004	Aug 7, 2024		RX	Yes	Yes	12,178,918		Y

International Patents for CREXONT

See the table below for patents covering CREXONT around the world.

Country	Patent Number	Title	Estimated Expiration
China	105658211	左旋多巴和/或左旋多巴的酯的粘膜粘附性、控制释放调配物和其用途 (Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof)
Colombia	2023009085	Pauta posológica de levodopa
European Patent Office	3054929	FORMULATIONS MUCOADHÉSIVES À LIBÉRATION CONTRÔLÉE DE LÉVODOPA ET/OU D'ESTERS DE LÉVODOPA ET LEURS UTILISATIONS (MUCO-ADHESIVE, CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND/OR ESTERS OF LEVODOPA AND USES THEREOF)
Japan	2019094353	レボドパ及び／又はレボドパのエステルの粘膜付着性制御放出配合物、並びにその使用 (MUCOADHESIVE CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND/OR ESTERS OF LEVODOPA, AND USES THEREOF)
Japan	2016532655	レボドパ及び／又はレボドパのエステルの粘膜付着性制御放出配合物、並びにその使用
Mexico	369315
South Korea	20230124622

Market Dynamics and Financial Trajectory for CREXONT

Introduction to CREXONT

CREXONT, developed by Amneal Pharmaceuticals, Inc., is a novel oral formulation of carbidopa and levodopa extended-release capsules, recently approved by the U.S. FDA for the treatment of Parkinson's disease. This drug combines immediate-release granules and extended-release pellets, designed to provide longer periods of symptom control, known as "Good On" time, with less frequent dosing[1][4].

Market Need and Target Population

Parkinson's disease is the fastest-growing neurological disorder worldwide, with approximately 1 million people diagnosed in the U.S. and 90,000 new cases diagnosed each year. The current treatment paradigm often involves multiple daily doses of immediate-release carbidopa and levodopa, leading to motor fluctuations and reduced "Good On" time. CREXONT addresses this need by offering a formulation that extends the duration of symptom control with fewer doses[1][4].

Launch and Availability

CREXONT was launched in U.S. pharmacies in September 2024, following FDA approval. This launch is part of Amneal's strategic expansion into the specialty pharmaceuticals market and marks a significant addition to their portfolio of over 280 generic and specialty pharmaceuticals[1][2][4].

Financial Projections and Revenue Potential

Analysts expect CREXONT to be a major revenue contributor for Amneal. Here are some key financial projections:

• Peak Sales: CREXONT is projected to achieve peak U.S. sales between $300 million and $500 million[2][3].
• Payer Coverage: By 2025, analysts expect CREXONT to achieve approximately 50% payer coverage, which could significantly boost revenue[3].
• Specialty Revenues: With the addition of CREXONT, Amneal's specialty revenues are projected to surpass $500 million by 2027[2][3].

Impact on Amneal's Financial Performance

The launch of CREXONT is expected to bolster Amneal's financial health in several ways:

• Revenue Growth: The strong performance of CREXONT is anticipated to contribute to Amneal's overall revenue growth. The company has raised its full-year guidance for 2024, reflecting a 13% to 17% year-over-year growth in net revenue[2][3].
• Adjusted EBITDA and EPS: Amneal's adjusted EBITDA and EPS are expected to increase, with adjusted EBITDA projected between $610 million and $630 million and adjusted EPS between $0.57 and $0.63 for 2024[2].
• Market Capitalization: Amneal's market capitalization stands at $2.69 billion, indicating its significant size and potential for further growth[1].

Strategic Significance

The successful launch of CREXONT is strategically important for several reasons:

• Offset for Rytary's Loss of Exclusivity: CREXONT's launch is timed to help mitigate the impact of Rytary's loss of exclusivity in August 2025, ensuring revenue stability during this transition[3].
• Market Expansion: CREXONT could open doors for Amneal in new therapeutic areas or patient populations, leading to additional product development opportunities or market share gains[3].
• Improved Margins: As a branded product, CREXONT may offer higher profit margins compared to generic drugs, potentially boosting Amneal's overall profitability[3].

Competitive Landscape and Challenges

While CREXONT presents significant opportunities, Amneal faces several challenges and competitive pressures:

• Competition in Generic Pharmaceuticals: The generic pharmaceuticals market is highly competitive, with intense competition from other generic drug makers[3].
• Regulatory Hurdles: New product development and approvals are subject to regulatory hurdles, which can impact the launch and success of drugs like CREXONT[3].
• Market Saturation: There is a potential for market saturation in certain generic drug categories, which could affect CREXONT's market penetration[3].

Analyst Views and Targets

Analysts have been positive about Amneal's prospects, particularly with the launch of CREXONT:

• Barclays Capital: Analysts from Barclays Capital have maintained an "Overweight" rating with a target price of $10.00, reflecting their confidence in Amneal's growth potential[3].

Conclusion on Market Dynamics

The launch of CREXONT marks a significant milestone for Amneal Pharmaceuticals, addressing a critical need in the treatment of Parkinson's disease. With its innovative formulation and strong financial projections, CREXONT is poised to be a key driver of Amneal's growth and financial performance in the coming years.

Key Takeaways

• Innovative Formulation: CREXONT combines immediate-release granules and extended-release pellets to provide longer "Good On" time with less frequent dosing.
• Revenue Potential: Projected peak U.S. sales between $300 million and $500 million.
• Strategic Importance: Timed to offset the loss of exclusivity for Rytary and potentially expand Amneal's market presence.
• Financial Impact: Expected to contribute significantly to Amneal's revenue growth and profitability.
• Competitive Landscape: Faces competition in the generic pharmaceuticals market and regulatory hurdles.

Frequently Asked Questions (FAQs)

Q: What is CREXONT, and how does it differ from existing treatments for Parkinson's disease? A: CREXONT is an extended-release capsule formulation of carbidopa and levodopa, designed to provide longer "Good On" time with less frequent dosing compared to immediate-release formulations.

Q: When was CREXONT launched, and what is its current availability? A: CREXONT was launched in U.S. pharmacies in September 2024, following FDA approval.

Q: What are the financial projections for CREXONT? A: Analysts expect CREXONT to achieve peak U.S. sales between $300 million and $500 million and achieve approximately 50% payer coverage by 2025.

Q: How does the launch of CREXONT impact Amneal's financial performance? A: The launch of CREXONT is expected to contribute to Amneal's revenue growth, with the company raising its full-year guidance for 2024 and projecting increased adjusted EBITDA and EPS.

Q: What are the strategic benefits of CREXONT for Amneal Pharmaceuticals? A: CREXONT helps mitigate the impact of Rytary's loss of exclusivity, offers higher profit margins, and could expand Amneal's market presence in new therapeutic areas.

Sources:

1. Investing.com: "Amneal launches Parkinson's drug Crexont in US pharmacies"
2. Investing.com: "Earnings call: Amneal Pharmaceuticals raises guidance, reports strong Q2"
3. Investing.com: "Amneal Pharmaceuticals' SWOT analysis: generic drug maker's stock poised for growth"
4. RxInsider: "Amneal Receives U.S. FDA Approval for IPX203 for Treatment of Parkinson’s Disease to be Launched as Crexont"