Didanosine - Generic Drug Details

What are the generic sources for didanosine and what is the scope of freedom to operate?

Didanosine is the generic ingredient in three branded drugs marketed by Aurobindo Pharma, Barr, Norvium Bioscience, Bristol Myers Squibb, Bristol, and Aurobindo, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for didanosine.

Summary for didanosine

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	9
Drug Master File Entries:	8
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	155
Patent Applications:	7,881
What excipients (inactive ingredients) are in didanosine?	didanosine excipients list
DailyMed Link:	didanosine at DailyMed

Recent Clinical Trials for didanosine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Chang Gung Memorial Hospital	Phase 1
TTY Biopharm	Phase 1
Intergroupe Francophone de Cancerologie Thoracique	Phase 2

See all didanosine clinical trials

Medical Subject Heading (MeSH) Categories for didanosine

Anti-HIV Agents

Antimetabolites

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for didanosine

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DIDANOSINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIDEX	Capsules	didanosine	75 mg	020155	1	2011-06-06
VIDEX EC	Delayed-release Capsules	didanosine	200 mg, 250 mg and 400 mg	021183	1	2004-06-01

US Patents and Regulatory Information for didanosine

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	FOR SOLUTION;ORAL	020155-003	Oct 9, 1991		DISCN	No	No
Barr	DIDANOSINE	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	077167-003	Dec 3, 2004		DISCN	No	No
Aurobindo	DIDANOSINE	didanosine	TABLET, FOR SUSPENSION;ORAL	077275-003	Aug 14, 2012		DISCN	No	No

Expired US Patents for didanosine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	VIDEX	didanosine	FOR SOLUTION;ORAL	020156-001	Oct 9, 1991
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-003	Oct 9, 1991
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-002	Oct 31, 2000

Market Dynamics and Financial Trajectory for Didanosine

Introduction

Didanosine, marketed under the brand name Videx among others, is a crucial medication in the treatment of HIV/AIDS. Here, we delve into the market dynamics and financial trajectory of didanosine, exploring its history, market impact, and the challenges it faces.

Historical Context

Didanosine was approved by the FDA on October 9, 1991, as the second drug for treating HIV infection in the United States. This approval marked a significant milestone in HIV treatment, helping to reduce the price of zidovudine (ZDV), the first anti-HIV drug[4].

Market Impact

Initial Formulation and Challenges

The original formulation of didanosine was in the form of chewable tablets that included an antacid buffering compound to protect the drug from stomach acid. However, these tablets were large, fragile, and had unpleasant side effects such as diarrhea. Despite these issues, the drug was a vital addition to the HIV treatment regimen[4].

Reformulation and Generic Entry

In 2000, the FDA approved a new formulation of didanosine, known as Videx EC, which used coated microspheres instead of the buffering compound. This reformulation allowed for once-a-day dosing and improved patient compliance. At the end of the ten-year license period, the NIH licensed didanosine to Barr Laboratories, leading to the first generic anti-HIV drug in the United States[4].

Financial Trajectory

Patent Expiry and Generic Competition

One of the patents for didanosine expired in the United States on August 29, 2006, although other patents extended beyond this date. The expiry of patents led to increased generic competition, which significantly impacted the financial trajectory of didanosine. Generic manufacturers such as Aurobindo, Cipla, and Mylan began producing didanosine, reducing the market share and revenue of the original brand-name drug[1][4].

Price Dynamics

The entry of generic versions of didanosine led to a decrease in prices. Generic competition, including authorized generics, has been shown to lower retail and wholesale prices of drugs. For instance, authorized generic competition can reduce retail generic prices by 4-8% and wholesale generic prices by 7-14% compared to prices without such competition[3].

Market Dynamics

Demand for Newer Drugs

The HIV drugs market is highly dynamic, with patients often preferring newer drugs over older ones due to their safer profiles and lower risk of drug resistance. This preference poses a challenge for generic manufacturers, including those producing didanosine, as newer drugs can make older ones obsolete. For example, several older blockbuster HIV drugs, including didanosine, have been removed from the market in recent years[1].

Market Restraining Factors

• Needle Fear and Medical Mistrust: While didanosine is an oral medication, the broader HIV treatment market faces challenges such as needle fear and medical mistrust, which can affect adherence to treatment regimens and overall market growth[1].
• Social Stigma: HIV treatment still carries a social stigma, which can impact the demand and financial performance of HIV drugs, including didanosine[1].
• Lack of Trained Staff and Infrastructural Facilities: In many regions, the lack of trained staff and adequate infrastructural facilities can hinder the effective distribution and administration of HIV drugs, affecting their market performance[1].

Market Opportunities

Self-Administrating Injectables

Although didanosine is an oral medication, the broader HIV treatment market is seeing a shift towards self-administering injectables, which could influence future formulations and delivery methods for similar drugs[1].

Broadly Neutralizing Antibodies (bNAbs)

The development of broadly neutralizing antibodies (bNAbs) offers new opportunities in HIV prevention and treatment. While didanosine is not directly involved in this area, the advancements in bNAbs could drive innovation and investment in the HIV treatment sector, potentially benefiting related drugs[1].

Financial Projections

The global HIV drugs and injectables market, which includes didanosine, is forecast to surpass $35 billion in revenue by 2024 and is expected to see strong growth through to 2034. However, the specific financial trajectory for didanosine will be influenced by the ongoing shift towards newer, safer drugs and the competitive landscape of generic manufacturers[1].

Key Takeaways

• Didanosine's market impact was significant upon its approval, helping to reduce the price of other anti-HIV drugs.
• The drug faced challenges with its initial formulation but was improved with the Videx EC reformulation.
• Generic competition, including authorized generics, has reduced the prices and market share of brand-name didanosine.
• The HIV drugs market is highly dynamic, with a preference for newer, safer drugs.
• Market restraining factors include social stigma, needle fear, and lack of trained staff and infrastructural facilities.

FAQs

Q: When was didanosine approved by the FDA? A: Didanosine was approved by the FDA on October 9, 1991[4].

Q: What were the challenges with the initial formulation of didanosine? A: The initial formulation of didanosine was in the form of chewable tablets that were large, fragile, and had unpleasant side effects such as diarrhea[4].

Q: How did the reformulation of didanosine improve its use? A: The reformulation of didanosine into Videx EC used coated microspheres, allowing for once-a-day dosing and improving patient compliance[4].

Q: What impact did generic competition have on the market for didanosine? A: Generic competition led to a decrease in prices and reduced the market share and revenue of the original brand-name drug[1][3].

Q: What are some of the broader market dynamics affecting HIV drugs like didanosine? A: The market is influenced by factors such as demand for newer drugs, social stigma, needle fear, and lack of trained staff and infrastructural facilities[1].

Sources

1. GlobeNewswire: HIV Drugs and Injectables Market Report 2024-2034: U.S. Targets to End the HIV Epidemic in the Country by 2030.
2. Oxford University Press: Allocating scarce financial resources for HIV treatment: benchmarking prices of antiretroviral medicines in Latin America.
3. Federal Trade Commission: Authorized Generic Drugs: Short-Term Effects and Long-Term Impact.
4. Wikipedia: Didanosine.