DHIVY Drug Patent Profile

When do Dhivy patents expire, and what generic alternatives are available?

Dhivy is a drug marketed by Avion Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has seven patent family members in six countries.

The generic ingredient in DHIVY 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 Dhivy

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

Summary for DHIVY

International Patents:	7
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for DHIVY
What excipients (inactive ingredients) are in DHIVY?	DHIVY excipients list
DailyMed Link:	DHIVY at DailyMed

See drug prices for DHIVY

Pharmacology for DHIVY

Drug Class

Aromatic Amino Acid

US Patents and Regulatory Information for DHIVY

DHIVY is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avion Pharms	DHIVY	carbidopa; levodopa	TABLET;ORAL	214869-001	Nov 12, 2021		RX	Yes	Yes
Avion Pharms	DHIVY	carbidopa; levodopa	TABLET;ORAL	214869-001	Nov 12, 2021		RX	Yes	Yes
Avion Pharms	DHIVY	carbidopa; levodopa	TABLET;ORAL	214869-001	Nov 12, 2021		RX	Yes	Yes			Y

EU/EMA Drug Approvals for DHIVY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amneal Pharma Europe Ltd	Numient	levodopa, carbidopa	EMEA/H/C/002611 Symptomatic treatment of adult patients with Parkinson’s disease	Withdrawn	no	no	no	2015-11-19

International Patents for DHIVY

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

Country	Patent Number	Title	Estimated Expiration
China	111954523
Japan	2021517128
Japan	2021517128	レボドパ分割用量組成物および使用

Market Dynamics and Financial Trajectory for DHIVY

Introduction to DHIVY

DHIVY, a carbidopa/levodopa combination, is a significant player in the Parkinson's disease drugs market. It is the first and only carbidopa/levodopa fractional tablet designed to be divided, which was commercially released by Avion Pharmaceuticals, LLC, a division of Alora Pharmaceuticals, following FDA approval in November 2021[1].

Market Size and Growth

The global Parkinson's disease drugs market, within which DHIVY operates, is projected to grow significantly. By 2024, the market is expected to reach USD 5.56 billion and is anticipated to grow at a CAGR of 3.58% to reach USD 6.63 billion by 2029[1].

Regional Market Performance

North America, particularly the United States, is expected to dominate the Parkinson's disease drugs market, including the segment for DHIVY. This dominance is attributed to high healthcare expenditure, the strong presence of major market players, frequent product approvals, and an increasing number of Parkinson's disease cases in the region[1].

Competitive Landscape

The Parkinson's disease drugs market is highly competitive, with several major players such as GlaxoSmithKline PLC, Boehringer Ingelheim International GmbH, Newron Pharmaceuticals SPA, F. Hoffmann-La Roche Ltd, and AbbVie Inc.[1]. The recent commercialization agreements and new drug applications, such as AbbVie's submission for ABBV-951, indicate a dynamic market environment where innovative products like DHIVY can gain traction[1].

Product Launches and Approvals

The launch of DHIVY in February 2022 marked a significant milestone in the treatment of Parkinson's disease. This product, approved by the FDA, addresses the need for more flexible dosing options, which can enhance patient compliance and treatment outcomes[1].

Pricing and Affordability

The cost of DHIVY is around $352 for a supply of 100 tablets, depending on the pharmacy. However, generic versions of carbidopa/levodopa are available at significantly lower prices, such as $14.27 for 30 tablets, which can impact the market share of branded products like DHIVY[2].

Financial Impact of Novel Drug Delivery Systems

The introduction of novel drug delivery systems, including fractional tablets like DHIVY, is expected to drive value growth in the Parkinson's disease market. These systems can offset revenue losses due to patent expiries and contribute to a net gain in revenue over the forecast period. For instance, new launch events are expected to add approximately $14.8 billion in revenue between 2020 and 2029, while losses due to patent expiries are estimated at $4.7 billion[3].

Emerging Pipeline and Market Dynamics

The emerging pipeline for Parkinson's disease treatments is robust, with late-stage drugs like Supernus Pharmaceuticals/Britannia Pharmaceuticals' SPN-830 and AbbVie's tavapadon expected to enter the market. These new therapies could significantly impact market dynamics and potentially influence the market share of existing products like DHIVY[4].

Challenges and Side Effects

While DHIVY offers significant benefits, it also comes with potential side effects such as dyskinesias, impulse control disorders, and increased intraocular pressure in patients with glaucoma. These side effects may require dosage adjustments or medication changes, which can affect patient adherence and overall market performance[5].

Key Takeaways

• Market Growth: The Parkinson's disease drugs market, including DHIVY, is expected to grow at a CAGR of 3.58% from 2024 to 2029.
• Regional Dominance: North America, particularly the United States, will dominate the market due to high healthcare expenditure and frequent product approvals.
• Competitive Landscape: The market is highly competitive with several major players, and innovative products like DHIVY are crucial for market share.
• Pricing: DHIVY's pricing is competitive, but generic alternatives can impact its market share.
• Novel Drug Delivery Systems: These systems are expected to drive value growth and offset revenue losses due to patent expiries.

FAQs

Q: What is the current market size of the Parkinson's disease drugs market?

The global Parkinson's disease drugs market size is expected to reach USD 5.56 billion in 2024[1].

Q: Who are the major players in the Parkinson's disease drugs market?

Major players include GlaxoSmithKline PLC, Boehringer Ingelheim International GmbH, Newron Pharmaceuticals SPA, F. Hoffmann-La Roche Ltd, and AbbVie Inc.[1].

Q: What is the significance of DHIVY in the Parkinson's disease treatment market?

DHIVY is the first and only carbidopa/levodopa fractional tablet, offering flexible dosing options for patients with Parkinson's disease[1].

Q: How does the pricing of DHIVY compare to generic alternatives?

DHIVY costs around $352 for 100 tablets, while generic carbidopa/levodopa can cost as low as $14.27 for 30 tablets[2].

Q: What are the potential side effects of DHIVY?

Potential side effects include dyskinesias, impulse control disorders, and increased intraocular pressure in patients with glaucoma[5].

Sources:

1. Mordor Intelligence - Global Parkinson's Disease Drugs Market Size
2. Drugs.com - Dhivy Prices, Coupons, Copay Cards & Patient Assistance
3. IQVIA - Novel Drug Delivery Systems Drive Value Growth in the Parkinson's Disease Market
4. GlobeNewswire - Parkinson's Disease Market is Expected to Showcase a Significant Growth at a CAGR of 5.8% During the Study Period (2020–2034)
5. DHIVY Full Prescribing Information - DHIVY (carbidopa/levodopa) Full Prescribing Information