ZIAGEN Drug Patent Profile

Which patents cover Ziagen, and what generic alternatives are available?

Ziagen is a drug marketed by Viiv Hlthcare and is included in two NDAs.

The generic ingredient in ZIAGEN is abacavir sulfate. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the abacavir sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ziagen

A generic version of ZIAGEN was approved as abacavir sulfate by MYLAN PHARMS INC on June 18^th, 2012.

Summary for ZIAGEN

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	15
Patent Applications:	4,174
Drug Prices:	Drug price information for ZIAGEN
What excipients (inactive ingredients) are in ZIAGEN?	ZIAGEN excipients list
DailyMed Link:	ZIAGEN at DailyMed

See drug prices for ZIAGEN

Recent Clinical Trials for ZIAGEN

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

Sponsor	Phase
Cellceutix Corporation	Phase 1
Bayside Health	Phase 4
AIDS Clinical Trials Group	Phase 3

See all ZIAGEN clinical trials

Pharmacology for ZIAGEN

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Paragraph IV (Patent) Challenges for ZIAGEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZIAGEN	Oral Solution	abacavir sulfate	20 mg/mL	020978	1	2012-12-27
ZIAGEN	Tablets	abacavir sulfate	300 mg	020977	1	2009-01-28

US Patents and Regulatory Information for ZIAGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998	AA	RX	Yes	Yes
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998		DISCN	Yes	No

Expired US Patents for ZIAGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998	6,641,843*PED
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998	5,034,394*PED
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998	5,089,500*PED
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998	5,034,394*PED
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998	6,294,978*PED
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998	6,294,540*PED
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998	5,089,500*PED

International Patents for ZIAGEN

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

Country	Patent Number	Title	Estimated Expiration
Australia	3702589
Brazil	9809127
Germany	19975058
Argentina	015668	SAL DE HEMISULFATO DE (1S,4R)-CIS-4-[2-AMINO-6-(CICLOPROPILAMINO)-9H-PURIN-9-IL]-2-CICLOPENTEN-1-METANOL Y FORMULACION FARMACEUTICA QUE LA CONTIENE
African Intellectual Property Organization (OAPI)	11304	Carbocyclic nucleoside hemisulfate and its use in treating viral infections
Finland	894545
New Zealand	510622	Carbocyclic nucleoside salts

Supplementary Protection Certificates for ZIAGEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	23/2005	Austria		PRODUCT NAME: KOMBINATION, UMFASSEND ABACAVIR BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES ESTERS ODER SOLVAT DAVON UND LAMIVUDIN BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES; REGISTRATION NO/DATE: EU/1/04/298/001, EU/1/04/298/002 20041217
0434450	33/1999	Austria		PRODUCT NAME: ''ABACAVIR'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER DERIVATS, EINSCHLIESSLICH ABACAVIR-SULFAT.; NAT. REGISTRATION NO/DATE: EU/1/99/112/001 EU/1/99/112/002 19990708; FIRST REGISTRATION: LI 55048 001, 55049 002 19990628
0817637	05C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
0434450	1999C0033	Belgium		PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
0817637	C300195	Netherlands		PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDB AAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HEMISULFAAT, EN LAMIV UDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT; REGISTRTION NO/DATE: EU/04/298/001-002 20041217
0434450	C990028	Netherlands		PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708
0434450	990028	Netherlands		PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708

ZIAGEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZIAGEN

Introduction to ZIAGEN

ZIAGEN, also known as abacavir, is a nucleoside reverse transcriptase inhibitor (NRTI) used in the treatment of HIV-1 infection. It is part of the antiretroviral therapy regimen and is often used in combination with other medications to manage the virus.

Market Overview of HIV Drugs

The HIV drug market, particularly in the United States, has seen significant growth and advancements in recent years. The market is driven by high research and development activities, favorable dynamics for high-potent antiretrovirals, and increasing patient-centric approaches by bio-pharmaceutical companies[1].

Growth Areas and Drivers

• Research and Development: The R&D pipelines for HIV drugs, including ZIAGEN, are expanding rapidly. This has led to the development of novel products and therapies that are highly effective in managing HIV infection[1].
• Clinical Trials and Approvals: Continuous clinical trials and regulatory approvals are crucial for the market growth. For instance, the success rate associated with available antiretrovirals, including ZIAGEN, has been increasing at historic levels[1].
• Patient-Centric Approaches: Bio-pharmaceutical companies are adopting patient-centric strategies, which include better healthcare delivery and organizational changes to improve patient outcomes. This approach has been a key driver in the market expansion[1].

Financial Performance of ZIAGEN

• Revenue Contribution: ZIAGEN, as part of the broader HIV drug market, contributes significantly to the revenue generated by pharmaceutical companies. The US HIV drug market is expected to exceed billions of dollars in the coming years, with a high compound annual growth rate (CAGR)[1].
• Sales and Pricing: The sales of ZIAGEN are influenced by its pricing and dosage. The drug is available in various formulations, and its pricing is analyzed in detail in market reports. For example, the "US HIV Infection Drug Market, Dosage, Price, Sales Insight 2021 - 2026" report provides comprehensive insights into the pricing and sales analysis of ZIAGEN and other HIV drugs[1].

Competitive Landscape

• Market Segments: The HIV drug market is segmented into various drug classes, including NRTIs, non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), and others. ZIAGEN falls under the NRTI category, which is a significant segment in the market[1].
• Key Players: The market is dominated by several key players, including ViiV Healthcare, which is responsible for ZIAGEN. These companies invest heavily in R&D and marketing, which drives the market forward[1].

Dosage, Formulation, and Patent Insights

• Dosage and Formulation: ZIAGEN is available in various dosages, including 300 mg tablets and oral solution. The drug can be administered once or twice daily, depending on the regimen. The dosage and formulation play a critical role in its efficacy and patient compliance[4].
• Patent Timeline: The patent status of ZIAGEN is an important factor in its market dynamics. As patents expire, generic versions of the drug can enter the market, potentially affecting the sales of the branded version[1].

Clinical Trials and Adverse Reactions

• Clinical Trials: ZIAGEN has undergone extensive clinical trials to establish its safety and efficacy. These trials have highlighted its effectiveness in combination therapy for HIV-1 infection. However, they have also identified potential adverse reactions such as drug hypersensitivity, headaches, nausea, and fatigue[4].
• Adverse Reactions: The common adverse reactions associated with ZIAGEN include dreams/sleep disorders, drug hypersensitivity, headaches, nausea, and diarrhea. Severe reactions such as severe drug hypersensitivity and diarrhea have been noted, especially with once-daily dosing[4].

Market Projections and Future Outlook

• Market Growth: The US HIV drug market, including ZIAGEN, is projected to continue growing at a high CAGR. The market is expected to be driven by novel product launches, increased patient uptake, and favorable market dynamics[1].
• Technological Advancements: Technological advancements and innovations in drug delivery systems are expected to further enhance the market. Patient-centric approaches and personalized medicine are likely to play a significant role in the future of HIV treatment[1].

Key Takeaways

• Growing Market: The HIV drug market, including ZIAGEN, is experiencing significant growth driven by R&D, clinical trials, and patient-centric strategies.
• Financial Performance: ZIAGEN contributes substantially to the revenue of pharmaceutical companies, with the market expected to exceed billions of dollars in the coming years.
• Competitive Landscape: The market is competitive, with key players investing heavily in R&D and marketing.
• Clinical and Safety Profile: ZIAGEN has a well-established clinical and safety profile, with ongoing monitoring of adverse reactions.
• Future Outlook: The market is projected to continue growing, driven by technological advancements and personalized medicine.

Frequently Asked Questions (FAQs)

Q: What is ZIAGEN used for? A: ZIAGEN (abacavir) is used in the treatment of HIV-1 infection as part of antiretroviral therapy.

Q: Who are the key players in the HIV drug market? A: Key players include ViiV Healthcare, among others, which are involved in the development and marketing of HIV drugs like ZIAGEN.

Q: What are the common adverse reactions associated with ZIAGEN? A: Common adverse reactions include drug hypersensitivity, headaches, nausea, fatigue, and diarrhea.

Q: How is the market for HIV drugs expected to grow? A: The market is expected to grow at a high CAGR, driven by novel product launches, increased patient uptake, and favorable market dynamics.

Q: What role do patient-centric approaches play in the HIV drug market? A: Patient-centric approaches are crucial in driving market growth by improving healthcare delivery and patient outcomes, leading to organizational changes and better market acceptance.