ZERIT XR Drug Patent Profile

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

Zerit Xr is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in ZERIT XR is stavudine. There are fourteen drug master file entries for this compound. Additional details are available on the stavudine profile page.

Summary for ZERIT XR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	119
Patent Applications:	4,824
DailyMed Link:	ZERIT XR at DailyMed

US Patents and Regulatory Information for ZERIT XR

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	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-001	Dec 31, 2002		DISCN	No	No
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-004	Dec 31, 2002		DISCN	No	No
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-002	Dec 31, 2002		DISCN	No	No
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-003	Dec 31, 2002		DISCN	No	No

Expired US Patents for ZERIT XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-004	Dec 31, 2002	4,978,655*PED
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-001	Dec 31, 2002	4,978,655*PED
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-003	Dec 31, 2002	7,135,465*PED
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-004	Dec 31, 2002	7,135,465*PED

EU/EMA Drug Approvals for ZERIT XR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Zerit	stavudine	EMEA/H/C/000110 Hard capsulesZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.Powder for oral solutionZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.	Withdrawn	no	no	no	1996-05-08

International Patents for ZERIT XR

See the table below for patents covering ZERIT XR around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	4959101
Poland	366089
Georgia, Republic of	P20043285	Sustained Release Beadlets Containing Stavudine, Method for Their Production, Pharmaceutical Composition Containing the Same and Use Thereof for Treatment Retroviral Infections
Finland	875544

Supplementary Protection Certificates for ZERIT XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0273277	SPC/GB96/049	United Kingdom		PRODUCT NAME: STAVUDINE; REGISTERED: UK EU/1/96/009/001 19960508; UK EU/1/96/009/002 19960508; UK EU/1/96/009/003 19960508; UK EU/1/96/009/004 19960508; UK EU/1/96/009/005 19960508; UK EU/1/96/009/006 19960508; UK EU/1/96/009/007 19960508; UK EU/1/96/009/008 19960508; UK EU/1/96/009/009 19960508
0273277	C960024	Netherlands		PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 - EU/1/96/009/009 19960508
0383472	96C0040	Belgium		PRODUCT NAME: STAVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/009/001-009 19960509; FIRST REGISTRATION:
0273277	96C0039	Belgium		PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 19960508

ZERIT XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zerit XR

Introduction to Zerit XR

Zerit XR, also known as Stavudine, is a nucleoside reverse transcriptase inhibitor (NRTI) used in the treatment of HIV infection. It is part of the antiretroviral therapy regimen, which has been a cornerstone in managing HIV/AIDS.

US HIV Drug Market Overview

The US HIV drug market has seen significant growth and advancements in recent years. The market is driven by high research and development activities, leading to the launch of novel and more effective antiretroviral therapies. According to the "US HIV Infection Drug Market, Dosage, Price, Sales Insight 2021 - 2026" report, the success rate associated with available antiretrovirals is expanding at historic levels, boosting the overall market growth[1].

Clinical Trials and Regulatory Landscape

Zerit XR, like other HIV drugs, undergoes rigorous clinical trials before approval. The clinical trials landscape for HIV drugs is highly dynamic, with continuous efforts to improve efficacy and reduce side effects. Regulatory bodies such as the FDA play a crucial role in approving these drugs and ensuring their safety and efficacy[1].

Market Segmentation: NRTIs

Zerit XR falls under the category of NRTIs, which are a class of antiretroviral drugs. The market for NRTIs includes both branded and generic versions. The report highlights that drugs like Zerit XR have specific dosage, patent, price, and sales analyses that impact their market presence[1].

Generic Competition

Generic competition significantly affects the financial trajectory of branded drugs like Zerit XR. When a patent expires, generic versions can enter the market, leading to a decline in sales for the branded version. For example, the generic drug industry dynamics show that generic prices fall with the number of competitors, and prices begin to approach long-run marginal costs when there are 8 or more competitors[3].

Financial Impact of Generic Entry

The entry of generic versions of Zerit XR can drastically reduce its market share and revenue. This is evident from the experience of other pharmaceutical companies facing generic competition. For instance, Bristol-Myers Squibb faced a significant decline in Plavix sales due to generic entry, resulting in a loss of $1.2 billion to $1.4 billion in sales[5].

Patient-Centric Approaches and Market Strategies

To mitigate the impact of generic competition, pharmaceutical companies are adopting patient-centric approaches. These strategies include offering patient assistance programs, improving drug formulations, and enhancing patient engagement. For Zerit XR, such strategies could help maintain market share and patient loyalty even after generic entry[1].

Technological Advancements and Market Expansion

Technological advancements are a key driver in the HIV drug market. Companies are leveraging state-of-the-art technology to develop more potent and patient-friendly antiretrovirals. This technological push is expected to continue driving the market growth, even for drugs like Zerit XR, by improving their formulations and delivery systems[1].

Market Growth Projections

The US HIV drug market, including drugs like Zerit XR, is projected to grow exponentially. The market is expected to exceed billions of dollars in the next few years, driven by high compound annual growth rates and increased spending on novel product uptake. The total invoice spending and net manufacturer revenue for HIV drugs are also expected to grow significantly[1].

Key Drivers of Market Growth

High exchange rate dynamics and favorable dynamics for high-potent antiretrovirals are among the prominent drivers of the market growth. Additionally, the increasing rate of novel product uptake and the emphasis on patient-centric approaches are contributing to the market's expansion[1].

Challenges and Opportunities

Despite the growth, the market faces challenges such as the mutative nature of the HIV virus and the need for continuous innovation. However, these challenges also present opportunities for research and development, leading to novel product launches and improved healthcare outcomes for HIV patients[1].

Illustrative Statistics

• The US HIV drug market is expected to grow at an exponential compound annual growth rate, driven by high-potent antiretrovirals and increased spending on novel products[1].
• Generic drug prices decline with the number of competitors, approaching long-run marginal costs when there are 8 or more competitors[3].

Expert Insights

"Pharmaceutical opportunities in the US related to HIV drug market are observed to be growing subsequently with time. The momentum that the US has shown towards HIV treatment is making the market a super growth attainer," as noted in the "US HIV Infection Drug Market, Dosage, Price, Sales Insight 2021 - 2026" report[1].

Highlight: Regulatory Impact

"The FDA increased their scrutiny of generic drug applications in mid 1989. While the policy may have allowed the FDA to discover, and therefore reject, more sub-standard applications, it also raised the cost of obtaining an ANDA for a qualified entrant," highlighting the regulatory impact on generic drug entry and market dynamics[3].

Key Takeaways

• The US HIV drug market, including Zerit XR, is experiencing significant growth driven by research and development and favorable market dynamics.
• Generic competition is a major factor affecting the financial trajectory of branded HIV drugs.
• Patient-centric approaches and technological advancements are crucial for maintaining market share.
• The market is projected to grow exponentially, driven by high compound annual growth rates and increased spending on novel products.

FAQs

Q: What is Zerit XR used for? A: Zerit XR, also known as Stavudine, is used in the treatment of HIV infection as part of antiretroviral therapy.

Q: How does generic competition affect Zerit XR? A: Generic competition can significantly reduce the market share and revenue of Zerit XR by offering cheaper alternatives, leading to a decline in sales.

Q: What are the key drivers of the US HIV drug market growth? A: High exchange rate dynamics, favorable dynamics for high-potent antiretrovirals, and increased spending on novel product uptake are key drivers.

Q: How do technological advancements impact the HIV drug market? A: Technological advancements improve drug formulations and delivery systems, driving market growth and enhancing patient outcomes.

Q: What is the projected growth of the US HIV drug market? A: The market is expected to exceed billions of dollars in the next few years, driven by high compound annual growth rates and increased spending on novel products.

Sources:

1. ResearchAndMarkets.com, "US HIV Infection Drug Market, Dosage, Price, Sales Insight 2021 - 2026".
2. Bristol Myers Squibb, "2010 Annual Report".
3. Federal Trade Commission, "Generic Drug Industry Dynamics".
4. Federal Trade Commission, "Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics".
5. Bristol Myers Squibb, "2006 Annual Report".