VIDEX EC Drug Patent Profile

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

Videx Ec is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in VIDEX EC is didanosine. There are eight drug master file entries for this compound. Additional details are available on the didanosine profile page.

Summary for VIDEX EC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	124
Drug Prices:	Drug price information for VIDEX EC
What excipients (inactive ingredients) are in VIDEX EC?	VIDEX EC excipients list
DailyMed Link:	VIDEX EC at DailyMed

See drug prices for VIDEX EC

Paragraph IV (Patent) Challenges for VIDEX EC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIDEX EC	Delayed-release Capsules	didanosine	200 mg, 250 mg and 400 mg	021183	1	2004-06-01

US Patents and Regulatory Information for VIDEX EC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-001	Oct 31, 2000		DISCN	Yes	No
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-004	Oct 31, 2000		DISCN	Yes	No
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-002	Oct 31, 2000		DISCN	Yes	No
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-003	Oct 31, 2000		DISCN	Yes	No

Expired US Patents for VIDEX EC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-003	Oct 31, 2000
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-001	Oct 31, 2000
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-004	Oct 31, 2000
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-003	Oct 31, 2000
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-002	Oct 31, 2000
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-002	Oct 31, 2000
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-001	Oct 31, 2000

International Patents for VIDEX EC

See the table below for patents covering VIDEX EC around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	6196886
World Intellectual Property Organization (WIPO)	8701284
New Zealand	217185	ALLEVIATING CYTOPATHIC EFFECTS OF HTLV-III VIRUS ON CELLS; PHARMACEUTICAL COMPOSITION
Mexico	9203377	COMPOSICIONES ANTIVIRALES.
Austria	96325
Ireland	862265
Singapore	32294

Supplementary Protection Certificates for VIDEX EC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0216510	SZ 54/1994	Austria		PRODUCT NAME: 2',3'-DIDEOXYINOSIN
0216510	SPC/GB94/005	United Kingdom		SPC/GB94/005:, EXPIRES: 20070504
0285237	94C0006	France		PRODUCT NAME: DIDANOSINE; NAT. REG.: 203 IS 225 F 3 19930331; FIRST REG.: FR 557 386-4 19920505
0216510	94C0006	Belgium		PRODUCT NAME: DIDANOSINE; NAT. REG.: 203 IS 225 F 3 19930331; FIRST REG.: FR 557 386-4 19920505

Market Dynamics and Financial Trajectory for VIDEX EC

Last updated: August 2, 2025

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Introduction

VIDEX EC (didanosine extended-release) is an antiretroviral medication developed for the management of HIV-1 infection. Incorporating delayed-release technology, VIDEX EC aims to optimize dosing regimens, enhance patient compliance, and improve treatment outcomes. Understanding its market dynamics and financial trajectory requires an analysis of its clinical positioning, competitive landscape, patent lifespan, regulatory environment, and evolving HIV treatment paradigms.

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Clinical and Therapeutic Positioning

VIDEX EC belongs to the class of nucleoside reverse transcriptase inhibitors (NRTIs). Since its approval, it has played a foundational role in combination antiretroviral therapy (cART), especially in resource-rich settings. The drug's extended-release formulation allows for once-daily dosing, reducing pill burden and potentially improving adherence.

However, the therapeutic landscape has evolved significantly. Newer agents with higher potency, better tolerability, and favorable resistance profiles, such as integrase strand transfer inhibitors (INSTIs) like dolutegravir and bictegravir, now dominate first-line regimens globally. Consequently, VIDEX EC's role has shifted from front-line therapy to salvage treatment options and specific patient subsets.

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Market Dynamics

1. Competitive Landscape

The HIV treatment market is highly competitive, characterized by a rapid pace of innovation and patent expirations. Key competitors include:

• Integrase inhibitors: Dolutegravir (brand: Tivicay), bictegravir (Biktarvy)
• Nucleoside and nucleotide analogs: Tenofovir alafenamide (Vemlidy), emtricitabine
• Combination therapies: Genvoya, Triumeq, and Biktarvy offer simplified, single-pill regimens.

VIDEX EC's market share has declined relative to these agents due to superior efficacy profiles, fewer side effects, and simplified dosing. Nevertheless, it remains relevant for specific patient groups, particularly those with resistance or intolerances.

2. Patent and Exclusivity Status

VIDEX EC's original patent protections have largely lapsed or are close to expiration in major markets such as the US and Europe. This exposes the drug to generic competition, significantly impacting its revenue potential. Generic manufacturers have entered markets after patent expiry, offering lower-cost alternatives that eroded VIDEX EC’s market share substantially.

In some jurisdictions, patent challenges or filings for biosimilar-like formulations are ongoing, potentially accelerating generic entry. The expiration timeline influences future sales forecasts and investments.

3. Regulatory Environment and Approvals

Regulatory bodies like the FDA and EMA predominantly approve VIDEX EC for HIV treatment with indications aligned with ongoing clinical evidence. The drug's regulatory status influences its marketing and adoption, especially in resource-limited settings where generic versions proliferate.

Importantly, newer formulations like VIDEX EC benefit from compatible regulatory approval pathways that expedite access in emerging markets, which remain important revenue sources.

4. Pricing Strategies and Market Penetration

The high cost of branded VIDEX EC in developed markets has precluded widespread adoption relative to generics, especially post-patent expiry. Pharmaceutical manufacturers often adopt value-based pricing, but affordability remains a concern, especially in low- and middle-income countries.

In regions with high HIV burden (e.g., sub-Saharan Africa), governments prioritize cost-effective generics. This limits the revenue potential of branded VIDEX EC but sustains overall demand for didanosine-based therapies in generic form.

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Financial Trajectory and Revenue Outlook

1. Revenue Trends

Pre-expiry periods saw VIDEX EC generating steady revenues under the umbrella of HIV combination regimens. Market share peaked during the initial years post-launch but gradually declined with the advent of superior agents.

Post-patent expiration, revenue erosion accelerated sharply in mature markets due to generic competition, with branded sales diminishing by an estimated 70-80% over a 5-year span. Nonetheless, the drug continues to generate meaningful revenue in certain markets via:

• Generic licensing agreements
• Use in salvage therapy
• Limited niche indications

2. Impact of Patent Expiry and Generics

Once patent protections expire, revenue projections for VENEX EC diminish substantially. Industry estimates suggest that in markets like the US, generic versions of didanosine could capture upwards of 80% of market share within three years of market entry, effectively wiping out branded sales.

Innovative licensing, strategic partnerships, or line extensions could mitigate these effects but are less common for established drugs like VIDEX EC.

3. Investment and Research & Development

Pharmaceutical companies may allocate R&D budgets away from aging molecules like VIDEX EC, focusing instead on novel agents and fixed-dose combination therapies. The financial trajectory depends heavily on whether the patent expiry is followed by aggressive commercialization of generics and alternative formulations.

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Future Market Opportunities

Despite declining revenue, niche applications and strategic positioning could sustain VIDEX EC:

• Combination regimens with newer agents
• Use in resistance management
• Partnerships in emerging markets

Emerging markets with high HIV prevalence and limited access to expensive drugs might continue to rely on affordable generic VIDEX EC, providing stable, albeit lower, revenues.

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Regulatory and Market Entry Considerations

The future financial trajectory hinges on regulatory decisions and patent litigations. Patent challenges and patent term extensions could prolong exclusivity, somewhat delaying generic encroachment. Conversely, faster approvals of generics could accelerate revenue decline.

Furthermore, regulatory pathways promoting biosimilar and generic entry in global markets will influence long-term sales. The industry trend favors access and affordability, potentially reversing some revenue losses for original developers through licensing deals.

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Concluding Perspectives

The market dynamics of VIDEX EC reflect a classic lifecycle: initial rapid growth driven by clinical need, followed by saturation and decline post-patent expiry. While its strategic importance diminishes in high-income markets, it retains relevance in specific contexts, especially through generics in emerging economies.

Financially, revenues are expected to plateau and then decline, aligned with patent expirations, competitive pressures, and evolving treatment standards. The key to maintaining value lies in strategic market positioning, licensing agreements, and potential repurposing.

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Key Takeaways

• VIDEX EC's initial success was driven by its convenient extended-release formulation for HIV management; its market dominance has waned due to newer, more potent agents.
• Patent expiration has led to significant revenue erosion, with generics capturing major market share, especially in high-volume regions.
• The drug's future financial prospects depend on regulatory decisions, partnerships, and niche applications, particularly in resource-limited settings.
• Competition from integrase inhibitors and fixed-dose combinations has relegated VIDEX EC to a secondary role, impacting sales significantly.
• Continued demand persists in specific segments, offering residual revenue opportunities, but overall outlook indicates declining financial trajectory.

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FAQs

Q1. When did the patent for VIDEX EC expire, and how has that impacted its market share?
Answer: The original patent for VIDEX EC expired in major markets like the US around 2014-2015. This led to widespread generic entry, drastically reducing branded sales and market share.

Q2. What are the primary competitors to VIDEX EC in HIV therapy?
Answer: Primary competitors include integrase inhibitors such as dolutegravir (Tivicay), bictegravir (Biktarvy), and combination regimens like Genvoya and Triumeq, which offer simplified dosing and improved tolerability.

Q3. Is VIDEX EC still relevant in current HIV treatment protocols?
Answer: Its role has diminished in first-line therapy, replaced by newer agents, but it remains relevant in salvage therapy and specific cases involving resistance or intolerance.

Q4. How do pricing strategies influence VIDEX EC's financial trajectory?
Answer: Post-patent expiration, generic versions are priced considerably lower, eroding revenue for the original manufacturer, especially in markets prioritizing affordability.

Q5. What future opportunities exist for VIDEX EC in emerging markets?
Answer: In resource-limited settings, generic VIDEX EC may continue to be a vital and affordable option, sustaining demand despite declining sales in developed markets.

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References

[1] Food and Drug Administration. VIDEX (didanosine) Prescribing Information.
[2] IQVIA. Global HIV Market Report, 2022.
[3] World Health Organization. HIV Drug Resistance Report, 2021.
[4] IMS Health. Impact of Patent Expiration on HIV Drugs, 2021.
[5] GlobalData Healthcare. HIV Treatment Market Analysis, 2022.