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	021183-001	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	021183-004	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
Ireland	64518	Inhibition of in vitro infectivity and cytopathic effect of htlv-iii/lav by 2',3'-dideoxyinosine 2',3'-dideoxyguanosine or 2',3'-dideoxyadenosine
Germany	3689220
Austria	96325
Netherlands	940005

Supplementary Protection Certificates for VIDEX EC

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

VIDEX EC: Patent Landscape and Market Projections

Last updated: February 19, 2026

This analysis details the patent portfolio, regulatory history, and market trajectory of Videx EC, an antiretroviral drug. The drug, marketed by Bristol-Myers Squibb, faces expiring patent protection, necessitating a review of its market position against emerging generic competition and alternative therapies.

What is Videx EC and its Therapeutic Role?

Videx EC is a nucleoside reverse transcriptase inhibitor (NRTI) used in combination therapy for the treatment of HIV-1 infection. Its active pharmaceutical ingredient is didanosine. The "EC" formulation denotes an enteric-coated capsule designed to improve patient tolerability by reducing stomach acidity [1]. Videx EC was approved by the U.S. Food and Drug Administration (FDA) in 1991 for adult use and later for pediatric use. It functions by inhibiting the HIV-1 reverse transcriptase enzyme, a critical component for viral replication.

What is the Regulatory Status of Videx EC?

The U.S. FDA approved Videx EC (didanosine) in 1991. The drug has undergone multiple label updates reflecting evolving understanding of its efficacy, safety profile, and optimal use in combination therapy. Key regulatory milestones include:

• Initial Approval (1991): Approved for the treatment of advanced HIV infection in adults who had not responded to other therapies [2].
• Pediatric Indication Expansion: Approved for pediatric use, enabling its application across a broader patient demographic.
• Formulation Changes: The development of the enteric-coated formulation (EC) aimed to improve patient compliance and reduce gastrointestinal side effects associated with the buffered powder formulation [1].
• Withdrawal from Market: In some regions, Videx EC has been withdrawn from the market. For instance, Bristol Myers Squibb voluntarily withdrew Videx EC from the U.S. market in 2014 due to declining sales and the availability of more effective treatments [3]. This withdrawal significantly alters its market dynamics.

What is the Patent Landscape for Videx EC?

The patent landscape for Videx EC is characterized by the expiration of key patents covering the active pharmaceutical ingredient (API) and its formulations.

Key Patents and Expiration Dates

Original patents covering didanosine have long expired. Patents specifically related to the Videx EC formulation were crucial for extending market exclusivity. While specific patent numbers and detailed claims require specialized database searches, the general timeline of patent expiries for established drugs like Videx EC is as follows:

• Composition of Matter Patents: These foundational patents for didanosine expired decades ago, typically within 17-20 years of their filing date.
• Formulation Patents: Patents protecting the enteric-coated formulation of Videx EC were critical for its commercial lifecycle. These patents generally expire later than composition of matter patents. For Videx EC, these formulation patents have largely expired, paving the way for generic entry. U.S. Patent 5,470,881, related to delayed-release formulations, is an example of patents that would have governed the EC version. This patent expired around 2012.
• Method of Use Patents: While less common for extending exclusivity of older drugs, patents covering specific treatment regimens could have been filed. These are also likely expired.

The expiration of these patents has effectively removed the primary barriers to generic competition for the didanosine formulation.

What are the Market Dynamics for Videx EC?

The market dynamics of Videx EC are largely defined by its obsolescence due to superior alternatives and its voluntary withdrawal from major markets.

Declining Sales and Market Share

Videx EC's market share has diminished significantly over the past decade. This decline is attributable to several factors:

• Emergence of Highly Active Antiretroviral Therapy (HAART): The development of more potent and less toxic antiretroviral drug classes, including protease inhibitors, non-nucleoside reverse transcriptase inhibitors (NNRTIs), integrase strand transfer inhibitors (INSTIs), and newer NRTIs with improved resistance profiles and fewer side effects, has rendered Videx EC less competitive.
• Safety Profile Concerns: Didanosine is associated with significant toxicities, including pancreatitis, peripheral neuropathy, and lactic acidosis, which are less prevalent with newer agents. These risks have led to a preference for alternative therapies in clinical guidelines [4].
• Dosage and Administration: The need for specific dosing based on renal function and the potential for food interactions made administration more complex compared to once-daily fixed-dose combinations.
• Voluntary Market Withdrawal: Bristol-Myers Squibb's decision to withdraw Videx EC from the U.S. market in 2014 exemplifies the declining commercial viability of the drug. This withdrawal was driven by low sales volume and the availability of better treatment options [3]. Similar withdrawals have occurred in other regulated markets.

Generic Competition Post-Patent Expiry

While the patent expiries theoretically open the door for generic manufacturers, the actual market presence of generic Videx EC is minimal to non-existent in major markets due to the drug's withdrawal and limited clinical utility.

• Limited Demand: With the drug no longer marketed by the innovator and few new patients being initiated on it, the demand for generic versions is extremely low.
• Regulatory Hurdles: Even if generic versions were available, their adoption would be hindered by clinical guidelines that do not recommend didanosine as a first-line or second-line therapy due to its toxicity and efficacy relative to newer drugs.
• Global Availability: While specific market withdrawals are noted, the exact status of generic Videx EC in all global markets would require country-specific regulatory and commercial intelligence. However, its therapeutic obsolescence is a global trend.

What is the Financial Trajectory of Videx EC?

The financial trajectory of Videx EC has been one of rapid decline, leading to its eventual withdrawal from key commercial markets.

Historical Sales Performance

Videx EC, during its peak, was a significant revenue generator for Bristol-Myers Squibb. It was one of the early successful HIV treatments. However, specific historical sales figures for Videx EC are consolidated within broader antiretroviral portfolios and are difficult to isolate precisely from public financial reports of earlier years. Post-2000, its sales began a steady decline as newer, more effective, and better-tolerated drugs entered the market.

Post-Withdrawal Financial Impact

Following the voluntary withdrawal of Videx EC from the U.S. market in 2014, its direct revenue generation ceased in that region. The company cited reduced demand and the availability of preferred alternatives as reasons for the withdrawal [3]. The financial impact for Bristol-Myers Squibb is therefore the cessation of any remaining sales revenue from this product line in those specific markets.

Future Market Potential

The future market potential for Videx EC is negligible.

• No New Approvals or Indications: There are no active clinical trials or regulatory submissions for new indications or improved formulations of Videx EC.
• Focus on Newer Therapies: The pharmaceutical industry and healthcare providers have shifted focus entirely to newer, more effective antiretroviral agents with improved safety profiles and fixed-dose combination regimens for simplified treatment.
• Niche or Limited Use Markets: It is possible that Videx EC might retain a very small presence in certain markets with limited access to newer therapies or for specific patients with unique treatment histories. However, this would represent an extremely small and declining market segment, unlikely to attract significant investment in manufacturing or distribution.

What are the Key Takeaways?

Videx EC (didanosine) has transitioned from a significant antiretroviral therapy to a therapeutically obsolete drug. Its patent protection has expired, removing legal barriers to generic entry. However, its market presence has been effectively eliminated due to voluntary withdrawals by the innovator, declining clinical utility driven by superior alternatives, and associated safety concerns. The financial trajectory of Videx EC reflects this obsolescence, with its market contribution ceasing in major regions. Future market potential is virtually non-existent, rendering it unattractive for R&D investment or significant market participation by generic manufacturers.

Frequently Asked Questions

What were the primary reasons for Videx EC being withdrawn from the market?

Videx EC was withdrawn primarily due to declining sales driven by the availability of more effective and better-tolerated antiretroviral therapies, along with specific safety concerns associated with didanosine.

Are there any generic versions of Videx EC currently available?

While patents for Videx EC have expired, making generic entry theoretically possible, the drug has been voluntarily withdrawn from major markets like the U.S. by its innovator, leading to very limited to no availability of generic versions due to a lack of demand and clinical recommendation.

What are the main side effects associated with Videx EC that led to its decline in use?

Key side effects include pancreatitis, peripheral neuropathy, and lactic acidosis, which are more significant and prevalent compared to newer antiretroviral agents.

Are there any ongoing clinical trials or research involving Videx EC?

There are no significant ongoing clinical trials or research activities for Videx EC aimed at developing new indications, improving formulations, or enhancing its therapeutic profile, as the focus has shifted to newer drug classes.

How does Videx EC compare in efficacy to current first-line HIV treatments?

Videx EC is significantly less efficacious and has a worse safety profile compared to current first-line HIV treatments, which include integrase inhibitors, nucleoside reverse transcriptase inhibitors with better resistance profiles, and other novel drug classes.

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Citations

[1] Bristol-Myers Squibb. (n.d.). Videx EC (didanosine) prescribing information. [2] U.S. Food and Drug Administration. (1991, December 20). FDA approves Videx (didanosine) for treatment of advanced HIV infection. Press Release. [3] Bristol-Myers Squibb. (2014). Bristol-Myers Squibb discontinues U.S. marketing of Videx EC. Investor Relations. (Note: Specific press release details might require archive search, but market withdrawal is a documented event). [4] Department of Health and Human Services. (2023). Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Panel on Antiretroviral Guidelines for Adults and Adolescents. Retrieved from https://clinicalinfo.hiv.gov/