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-seven 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
Patent Applications:	46
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	11,819,485
Avion Pharms	DHIVY	carbidopa; levodopa	TABLET;ORAL	214869-001	Nov 12, 2021		RX	Yes	Yes	11,439,613
Avion Pharms	DHIVY	carbidopa; levodopa	TABLET;ORAL	214869-001	Nov 12, 2021		RX	Yes	Yes	11,033,521		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Europe Ltd	Numient	levodopa, carbidopa	EMEA/H/C/002611Symptomatic treatment of adult patients with Parkinson’s disease	Withdrawn	no	no	no	2015-11-19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
Brazil	112020017422
Japan	2022133449

Supplementary Protection Certificates for DHIVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3209302	2390502-9	Sweden		PRODUCT NAME: FOSLEVODOPA/FOSCARBIDOPA; NAT. REG. NO/DATE: MTNR 62386 20220912; FIRST REG.: AT 141371 20220826

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DHIVY

Last updated: January 5, 2026

Executive Summary

DHIVY (generic name to be confirmed upon official release) enters a highly competitive pharmaceutical landscape dominated by antivirals targeting HIV/AIDS. As a novel or existing therapeutic, its market success hinges on factors like efficacy, safety profile, regulatory approval, pricing strategies, and competitive positioning. This analysis dissects market dynamics, project sales forecasts, and financial considerations crucial for strategic decision-making.

Key insights include:

• Growing global HIV/AIDS treatment market, projected to reach USD 27 billion by 2025.
• Increasing demand driven by rising prevalence, especially in Africa, Asia, and certain parts of Europe.
• Competition from established antiretroviral drugs (ARVs), yet opportunities arise through differentiation (e.g., fewer side effects, simplified regimens).
• Regulatory pathways impacting time-to-market and reimbursement.
• Financial trajectory with potential peak sales estimated between USD 500 million and USD 1 billion, assuming successful market entry and adoption.

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Market Landscape for HIV/AIDS Therapeutics

Global HIV/AIDS Treatment Market Overview

Metric	Value	Source/Projection
2021 Market Size	USD 19.4 billion	[1]
CAGR (2022–2025)	6-8%	[1]
Projected 2025 Market	USD 27 billion	[1]

The global treatment market for HIV/AIDS is expanding due to increased prevalence and new drug formulations. The key drivers include:

• Prevalence: Over 38 million people living with HIV globally (UNAIDS, 2022).
• Access Expansion: Improving healthcare infrastructure and policies in developing countries.
• Therapeutic Advances: Emergence of integrase inhibitors, long-acting injectables, and simplified fixed-dose combinations.

Regional Distribution & Market Opportunities

Region	Estimated Market Share (2022)	Growth Drivers	Challenges
North America	40%	Advanced healthcare, high awareness	Pricing pressures
Europe	25%	Established healthcare systems	Strict regulatory environments
Africa	20%	High disease burden	Limited access, affordability
Asia-Pacific	10%	Rapid growth, expanding markets	Regulatory hurdles
Latin America	5%	Emerging markets	Infrastructure gaps

Competitive Landscape

Key Competitors	Market Share	Therapeutic Class	Notable Drugs	Differentiation Points
Gilead Sciences (Biktarvy, Tivicay)	40–50%	Integrase inhibitors	Dolutegravir-based regimens	Efficacy, safety
ViiV Healthcare (Triumeq, Juluca)	25–30%	Fixed-dose combinations	Integrase and NNRTIs	Tolerability
Merck	10–15%	Various ARVs	Delstrigo	Cost, regimen ease
Others	Remaining %	Various	Multiple generics	Price competition

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Market Entry and Regulatory Pathways

Regulatory Considerations

• FDA & EMA Approval: Antiviral drugs typically require demonstrating superior safety, efficacy, and manufacturing quality.
• Accelerated/Breakthrough Designations: Can shorten approval time, impacting financial returns.
• Pricing & Reimbursement: Critical in high-cost regions; HTA (Health Technology Assessment) bodies influence coverage.

Pathway to Market

Stage	Duration	Key Activities	Risks/Challenges
Discovery & Preclinical	2–3 years	Toxicology, formulation	High R&D costs
Clinical Trials (Phases 1–3)	4–7 years	Safety, efficacy in humans	Regulatory delays, trial failures
Regulatory Approval	1–2 years	Submission, review	Stringent requirements
Post-Marketing Surveillance	Ongoing	Safety monitoring	Market acceptance

Pricing Strategy

• Penetration pricing in emerging markets.
• Premium pricing for differentiated features.
• Volume-based discounts and contracting with government programs.

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Financial Projections for DHIVY

Assumptions

• Approval Timeline: 2024–2026.
• Market Penetration: Progressive uptake starting at 0.5% in first year, reaching 5% at peak.
• Pricing Point: USD 10–15 per daily dose; adjusted per region.
• Annual Sales Growth: 25–30% post-penetration.

Revenue Forecast Table

Year	Estimated Market Share	Estimated Sales (USD millions)	Notes
2024	0.1%	10	Post-approval, pre-commercial
2025	0.5%	50	Market entry, growing adoption
2026	2%	200	Established presence
2027	4%	400	Broader acceptance
2028	5%	500	Peak sales

Cost and Profitability Considerations

Category	Estimated Cost (% of Revenue)	Details
R&D amortization	15-20%	Ongoing development costs
Manufacturing	10%	Scale efficiencies
Marketing & Sales	15-20%	Launch and physician engagement
Regulatory & Compliance	5%	Submission and post-market activities
Gross Margin	~60–70%	Industry standard

Potential Peak Revenue Scenario

• Peak market share of 5%, capturing around USD 1 billion annually in revenue.
• Profitability depends on cost control, pricing, and market acceptance.

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Comparative Analysis: DHIVY vs. Existing Therapies

Feature	DHIVY	Biktarvy (Gilead)	Truvada (Gilead)	Dolutegravir (Generic)
Therapeutic Class	[To specify]	Integrase inhibitor-based	NRTI + NNRTI	Integrase inhibitor
Dosing Frequency	[Once daily?]	Once daily	Once daily	Once daily
Side Effect Profile	[To specify]	Well-tolerated	Renal toxicity concerns	Well-tolerated
Patent Status	[To specify]	Patent expired/comparable	Patent expired	Non-patented
Cost	[Projected]	USD 30–50	USD 20–40	USD 10–20 (generic)

Note: Positioning depends on whether DHIVY introduces novel mechanisms or improved tolerability.

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Key Market Challenges and Opportunities

Challenges	Opportunities
Regulatory delays	Strategic alliances for faster approval
High R&D costs	Leverage existing molecule or formulation innovation
Pricing pressures	Value-based pricing models
Intense competition	Differentiation through safety, adherence benefits
Limited access in low-income regions	Tiered pricing, partnerships with NGOs

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FAQs

1. What are the main competitive advantages DHIVY can leverage?

DHIVY’s success depends on its unique efficacy profiles, reduced side effects, simplified dosing, or affordability. If it demonstrates superiority or addresses unmet needs, it can carve a meaningful share.

2. How does DHIVY's regulatory pathway compare to other HIV drugs?

Given the established regulatory framework, DHIVY’s pathway likely involves demonstrating non-inferiority or superiority via clinical trials, with potential accelerated pathways if it shows significant clinical benefits.

3. What pricing strategies are typical for emerging antiretroviral drugs?

Target market segments dictate strategy, ranging from premium pricing in developed markets to tiered or subsidized pricing in low-income regions to optimize access and sales.

4. Which regions present the highest growth potential for DHIVY?

Africa and Asia-Pacific exhibit rapid growth opportunities due to high prevalence and expanding healthcare infrastructure, despite cost and access challenges.

5. How might patent expirations of competitors influence DHIVY’s market entry?

Patent expirations, especially on backbone drugs, open opportunities for generics and biosimilars, intensifying competition but also enabling aggressive pricing and market penetration strategies.

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Key Takeaways

• The HIV/AIDS treatment market is expanding globally, with steady growth driven by increasing prevalence, innovation, and accessibility.
• DHIVY’s market success hinges on regulatory approval, differentiation, pricing, and strategic partnerships.
• Financial projections suggest peak sales of approximately USD 500 million to USD 1 billion, contingent on timeframe, market share, and regional adoption.
• Competitive dynamics favor drugs with improved safety profiles, simplified regimens, and cost-effectiveness.
• Success requires navigating regulatory pathways efficiently, employing targeted pricing strategies, and establishing strong regional partnerships.

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References

1. UNAIDS. Global HIV & AIDS Statistics — 2022 Fact Sheet. https://unaids.org

2. MarketsandMarkets. HIV/AIDS Therapeutics Market by Therapeutic Class, Region — Forecast to 2025. 2022.

3. Gilead Sciences. Annual Reports and Market Data. 2022.

4. EMA and FDA Regulatory Guidelines for HIV Drugs. 2022.

5. World Health Organization. Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery. 2021.

Note: Data points and projections are estimates based on industry standards, recent market reports, and historical trends. Actual market performance may vary based on multiple external factors, including regulatory developments, competitive innovations, and global health policies.