VIDEX Drug Patent Profile

Which patents cover Videx, and when can generic versions of Videx launch?

Videx is a drug marketed by Bristol and Bristol Myers Squibb and is included in four NDAs.

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

Summary for VIDEX

US Patents:	0
Applicants:	2
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	123
Patent Applications:	5,251
Drug Prices:	Drug price information for VIDEX
What excipients (inactive ingredients) are in VIDEX?	VIDEX excipients list
DailyMed Link:	VIDEX at DailyMed

See drug prices for VIDEX

Paragraph IV (Patent) Challenges for VIDEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIDEX	Capsules	didanosine	75 mg	020155	1	2011-06-06

US Patents and Regulatory Information for VIDEX

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	didanosine	TABLET, CHEWABLE;ORAL	020154-003	Oct 9, 1991		DISCN	Yes	No
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-004	Oct 9, 1991		DISCN	Yes	No
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-005	Oct 9, 1991		DISCN	No	No
Bristol	VIDEX	didanosine	FOR SOLUTION;ORAL	020156-001	Oct 9, 1991		DISCN	Yes	No
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-002	Oct 31, 2000		DISCN	Yes	No

Expired US Patents for VIDEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	VIDEX	didanosine	FOR SOLUTION;ORAL	020156-001	Oct 9, 1991	5,616,566*PED
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-003	Oct 9, 1991	4,861,759*PED
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-002	Oct 9, 1991	5,616,566*PED
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-003	Oct 9, 1991	5,254,539*PED
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-002	Oct 9, 1991	5,880,106*PED

International Patents for VIDEX

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

Country	Patent Number	Title	Estimated Expiration
Canada	1269044	INHIBITION DE L'INFECTIVITE IN VITRO ET DE L'EFFET CYTOPATHIQUE DU VIRUS HTLV-III/LAV PAR LA 2'3'-DIDEOXYINOSINE, LA 2'3'-DIDEOXYGUANOSINE OU LA 2'3'-DIDEOXYADENOSINE (INHIBITION OF IN VITRO INFECTIVITY AND CYTOPATHIC EFFECT OF HTLV-III/LAV BY 2'3'-DIDEOXYINOSINE, 2'3' - DIDEOXYGUANOSINE, OR 2'3' -DIDEOXYADENOSINE)
European Patent Office	0524579	Formulations orales dosées et améliorées de dideoxy purine nucléosides (Improved oral dosing formulations of dideoxy purine nucleosides)
European Patent Office	0493378
Hungary	220612	Eljárás didezoxi-purin nukleozidokat tartalmazó orális gyógyászati készítmények előállítására (PROCESS FOR PRODUCING ORAL PHARMACEUTICAL COMPOSITIONS COMPRISING DIDEOXYPURINE NUCLEOSIDES)
Japan	S62501712

Supplementary Protection Certificates for VIDEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0216510	SPC/GB94/005	United Kingdom		SPC/GB94/005:, EXPIRES: 20070504
0216510	SZ 54/1994	Austria		PRODUCT NAME: 2',3'-DIDEOXYINOSIN

Market Dynamics and Financial Trajectory for the Drug VIDEX

Introduction to VIDEX

VIDEX, also known as didanosine, is an antiretroviral drug used in the treatment of HIV/AIDS. It belongs to the class of nucleoside reverse transcriptase inhibitors (NRTIs), which work by inhibiting the reverse transcriptase enzyme that the HIV virus uses to replicate its genetic material.

Historical Context and Approval

VIDEX was approved by the U.S. Food and Drug Administration (FDA) in 1991, making it one of the earlier antiretroviral drugs available for HIV treatment. Its approval marked a significant milestone in the fight against HIV/AIDS, offering patients a new treatment option beyond zidovudine (Retrovir), which was the first approved antiretroviral drug[4].

Market Positioning

Early Market Presence

In the early 1990s, VIDEX was part of a limited but growing market for antiretroviral drugs. The drug's introduction helped expand treatment options for HIV patients, contributing to the overall growth of the antiretroviral market.

Competition and Market Share

As the antiretroviral market evolved, VIDEX faced increasing competition from newer and more effective drugs. The market saw the introduction of other NRTIs such as lamivudine (Epivir), tenofovir disoproxil fumarate (Viread), and combination therapies like Truvada and Atripla. This competition led to a decline in VIDEX's market share over time[4].

Financial Performance

Revenue Trends

The revenue generated by VIDEX has declined significantly since its peak in the late 1990s and early 2000s. This decline is attributed to the introduction of more advanced and effective antiretroviral therapies, as well as the genericization of many older antiretroviral drugs. Generic versions of VIDEX, which are cheaper and equally effective, have further eroded the market share of the branded version[3].

Cost and Pricing Dynamics

The cost of developing and maintaining VIDEX has been high, but the pricing dynamics have been influenced by the entry of generic competitors. Generic drug prices fall with the number of competitors, and in markets with eight or more competitors, prices approach long-run marginal costs. This has led to a reduction in the revenue generated by VIDEX as generic versions become more prevalent[3].

Clinical Trials and Development

Research and Development Pipeline

While VIDEX itself is no longer a focal point of new clinical trials, the research and development pipeline for HIV drugs continues to grow. Newer drugs and combination therapies are being developed, which has shifted the focus away from older drugs like VIDEX. However, the success rate associated with available antiretrovirals, including those that have evolved from the research on VIDEX, continues to expand at historic levels[4].

Global Market Impact

Regional Dynamics

The global anti-HIV drug market is dominated by regions like North America and the Asia-Pacific. In these regions, the prevalence of HIV and the availability of advanced treatment options have driven market growth. However, in regions like Sub-Saharan Africa, where HIV prevalence is high but access to effective drugs is limited, there is a significant unmet need for affordable anti-HIV drugs. VIDEX, being an older drug, has seen limited use in these regions due to its lower efficacy compared to newer treatments[1].

Challenges and Opportunities

Supply Chain Disruptions

The COVID-19 pandemic has highlighted the vulnerabilities in the global supply chain for anti-HIV drugs, including VIDEX. Disruptions in supply chains and the diversion of resources to COVID-19 treatments have affected the availability of HIV drugs, further reducing the market for older drugs like VIDEX[1].

Patient-Centric Approaches

Despite the decline of VIDEX, the overall HIV drug market is driven by patient-centric approaches and strategies. Bio-pharmaceutical companies are increasingly focusing on patient needs, which includes developing more effective and tolerable treatments. This shift has led to the development of new drugs that offer better healthcare outcomes, making the market more competitive and dynamic[4].

Key Players and Market Strategies

Innovative Technologies

Major players in the anti-HIV drug market, such as Gilead Sciences Inc., GSK, and Merck & Co., Inc., are leveraging innovative technologies like cell therapy and immunomodulation to develop new products. These innovations are creating lucrative opportunities for the anti-HIV drug market, further marginalizing older drugs like VIDEX[1].

Regulatory Environment

FDA Policies and Generic Drug Industry

Changes in FDA policies, such as increased scrutiny of generic drug applications, have affected the entry of new generic drugs into the market. While these policies aim to ensure the quality of generic drugs, they also increase the cost of obtaining approval, which can impact the pricing and availability of generic versions of drugs like VIDEX[3].

Conclusion

The market dynamics and financial trajectory for VIDEX reflect the broader trends in the anti-HIV drug market. From its early days as a pioneering treatment to its current status as a less preferred option, VIDEX has seen significant changes driven by advancements in medical science, market competition, and regulatory environments.

Key Takeaways

• Declining Market Share: VIDEX has seen a decline in market share due to the introduction of more effective antiretroviral therapies.
• Generic Competition: The availability of generic versions has further reduced the revenue generated by VIDEX.
• Global Market Trends: The global anti-HIV drug market is driven by regional dynamics, with North America and the Asia-Pacific being key regions.
• Innovative Technologies: New technologies and patient-centric approaches are driving the development of new anti-HIV drugs.
• Regulatory Impact: FDA policies and the generic drug industry dynamics have influenced the pricing and availability of VIDEX.

FAQs

1. What is VIDEX used for?

VIDEX, or didanosine, is an antiretroviral drug used in the treatment of HIV/AIDS.

2. When was VIDEX approved?

VIDEX was approved by the FDA in 1991.

3. Why has the market share of VIDEX declined?

The market share of VIDEX has declined due to the introduction of more effective and advanced antiretroviral therapies, as well as the availability of generic versions.

4. How has the COVID-19 pandemic affected the anti-HIV drug market?

The COVID-19 pandemic has caused disruptions in the supply chain and diverted resources to COVID-19 treatments, affecting the availability of HIV drugs like VIDEX.

5. What are the key drivers of the anti-HIV drug market?

The key drivers include high exchange rate dynamics, favorable government regulations, and the increasing uptake of novel products, along with patient-centric approaches and strategies.

Sources

1. Straits Research: Global Anti-HIV Drugs Market Size, Top Share, Forecast to 2032.
2. Blueprint Medicines: Blueprint Medicines Reports Fourth Quarter and Full Year 2022.
3. Federal Trade Commission: Generic Drug Industry Dynamics.
4. GlobeNewswire: United States HIV Infection Drug Market Report 2021-2026.
5. National Bureau of Economic Research: The Economics of Drug Development: Pricing and Innovation in a Changing Market.