COMBIVIR Drug Patent Profile

When do Combivir patents expire, and what generic alternatives are available?

Combivir is a drug marketed by Viiv Hlthcare and is included in one NDA.

The generic ingredient in COMBIVIR is lamivudine; zidovudine. There are twenty-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Combivir

A generic version of COMBIVIR was approved as lamivudine; zidovudine by LUPIN LTD on May 15^th, 2012.

Summary for COMBIVIR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	63
Patent Applications:	1,563
Drug Prices:	Drug price information for COMBIVIR
What excipients (inactive ingredients) are in COMBIVIR?	COMBIVIR excipients list
DailyMed Link:	COMBIVIR at DailyMed

See drug prices for COMBIVIR

Recent Clinical Trials for COMBIVIR

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

Sponsor	Phase
Augusta University	Phase 4
Massachusetts General Hospital	Phase 2
AIDS Clinical Trials Group	Phase 3

See all COMBIVIR clinical trials

Pharmacology for COMBIVIR

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

US Patents and Regulatory Information for COMBIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997		DISCN	Yes	No

Expired US Patents for COMBIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	5,905,082*PED
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	4,724,232*PED
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	4,837,208*PED
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	5,047,407*PED
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	5,859,021*PED
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	4,833,130*PED

EU/EMA Drug Approvals for COMBIVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ViiV Healthcare BV	Combivir	lamivudine, zidovudine	EMEA/H/C/000190 Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.,	Authorised	no	no	no	1998-03-18
Teva Pharma B.V.	Lamivudine/Zidovudine Teva	lamivudine, zidovudine	EMEA/H/C/001236 Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.	Withdrawn	yes	no	no	2011-02-28

International Patents for COMBIVIR

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

Country	Patent Number	Title	Estimated Expiration
Canada	1238277	NUCLEOSIDES ANTIVIRAUX (ANTIVIRAL NUCLEOSIDES)
China	1108655
Czechoslovakia	9104109
Spain	2200204
World Intellectual Property Organization (WIPO)	9221676
Yugoslavia	78291

Supplementary Protection Certificates for COMBIVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	05C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
0382526	19675032	Germany		PRODUCT NAME: LAMIVUDINE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH GEEIGNETEN SALZES; NAT. REGISTRATION NO/DATE: EU/1/96/015/001-002 19960808 FIRST REGISTRATION: CH 53662 53663 19960228
3494972	301277	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
0513917	98C0018	Netherlands		PRODUCT NAME: SAMARIUM LEXIDRONAM PENTASODIQUE; NAT. REGISTRATION NO/DATE: EU/1/97/057/001 19980205; FIRST REGISTRATION: CH - 54265 19971006
0513917	98C0020	Belgium		PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
0513917	SPC/GB98/019	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND ZIDOVUDINE; REGISTERED: UK EU/1/98/058/001 19980318; UK EU/1/98/058/002 19980318

Market Dynamics and Financial Trajectory for the Drug: COMBIVIR

Introduction to COMBIVIR

COMBIVIR is a combination antiretroviral drug containing lamivudine and zidovudine, used to treat the human immunodeficiency virus (HIV). This drug has been a cornerstone in HIV treatment due to its efficacy in managing the virus and preventing the progression to AIDS.

Current Market Size and Growth Potential

The global COMBIVIR market is anticipated to grow at a significant rate during the forecast period of 2023-2030. As of 2022, the market was valued at USD XX million and is expected to grow at a compound annual growth rate (CAGR) of approximately 3% until 2030[1].

Driving Factors for Growth

Several factors are driving the growth of the COMBIVIR market:

• Increased Cases of HIV/AIDS: The global rise in HIV/AIDS cases, particularly in regions with limited healthcare access, has increased the demand for antiretroviral therapies like COMBIVIR.
• Government Awareness and Healthcare Investments: Significant investments in healthcare departments and government awareness programs regarding HIV/AIDS have boosted the market. For instance, in the U.S., an estimated 1.2 million people had HIV at the end of 2021, highlighting the ongoing need for effective treatments[1].
• Drug Addiction: The surge in drug addiction among adults and adolescents, especially in the Asia-Pacific region, has contributed to the increased incidence of HIV, thereby driving the demand for COMBIVIR[1].

Market Segmentation

The COMBIVIR market is segmented based on type and application:

• Type: The market is divided into branded and generic segments. The branded segment currently holds the largest share due to its established reputation and efficacy[1].
• Application: The drug is used for both nonoccupational and occupational exposure to HIV. Nonoccupational exposure, which includes general public use, constitutes a significant portion of the market[1].

Regional Analysis

The global COMBIVIR market is analyzed across various regions, including North America, Europe, Asia-Pacific, and the Rest of the World. North America is expected to dominate the market during the forecast period due to high awareness and advanced healthcare infrastructure. The Asia-Pacific region, however, is expected to grow at a high CAGR due to increasing cases of HIV and rising healthcare investments[1].

Emerging Technologies and Trends

The production of cost-effective generic versions of COMBIVIR with high efficacy is an emerging trend. Generic drugs offer an affordable alternative, making antiretroviral therapy more accessible to a broader population. Additionally, advancements in long-acting regimens, as seen in other HIV treatments, could influence the future landscape of COMBIVIR and similar antiretroviral drugs[1][2].

Financial Trajectory

The financial trajectory of the COMBIVIR market is influenced by several factors:

• Revenue Growth: With a projected CAGR of 3%, the market is expected to see steady revenue growth. This growth is supported by increasing demand and expanding healthcare access in various regions[1].
• Market Size Estimation: The current market size and future projections are determined through a combination of secondary research and primary interviews. This approach helps in estimating the market size accurately and forecasting future trends[1].

Competitive Landscape

The competitive landscape of the COMBIVIR market includes several key players, with the branded segment dominated by major pharmaceutical companies. These companies are investing heavily in research and development to improve existing treatments and develop new, more effective antiretroviral therapies.

Example: ViiV Healthcare

ViiV Healthcare, a leader in HIV treatment, has shown significant growth in its long-acting regimens such as Cabenuva and Apretude. These innovations are transforming the HIV treatment landscape and could influence the future of COMBIVIR and similar drugs. ViiV Healthcare's strong commercial execution has driven growth, with their long-acting portfolio expected to exceed £2 billion in sales by 2026[2].

Challenges and Opportunities

Challenges

• Side Effects and Safety Concerns: COMBIVIR, like other antiretroviral drugs, can have severe side effects, such as acute exacerbations of hepatitis B in co-infected patients. Close monitoring of hepatic function is necessary for patients discontinuing the drug[4].
• Generic Competition: The rise of generic versions could challenge the market share of branded COMBIVIR, although generics also expand access to treatment.

Opportunities

• Expanding Healthcare Access: Increasing investments in healthcare and awareness programs in developing regions present significant opportunities for market growth.
• Innovative Formulations: The development of more convenient and effective formulations, such as long-acting regimens, could enhance patient compliance and treatment outcomes.

Key Takeaways

• The COMBIVIR market is expected to grow at a CAGR of 3% from 2023 to 2030.
• The branded segment currently dominates the market, but generic versions are emerging as a significant trend.
• North America is expected to dominate the market, while the Asia-Pacific region will experience high growth.
• Government awareness programs and healthcare investments are key drivers of the market.
• Emerging technologies, such as long-acting regimens, are set to transform the HIV treatment landscape.

FAQs

Q1: What is the current market size and growth potential of the COMBIVIR market?

The COMBIVIR market was valued at USD XX million in 2022 and is expected to grow at a CAGR of 3% during the forecast period (2023-2030)[1].

Q2: What are the driving factors for the growth of the COMBIVIR market?

Increased drug addiction, surge in awareness programs regarding HIV/AIDS, and rising investments in healthcare departments are the driving factors for the growth of the COMBIVIR market[1].

Q3: Which segment has the largest share of the COMBIVIR market by type?

The branded segment has the largest share of the COMBIVIR market by type[1].

Q4: What are the emerging technologies and trends in the COMBIVIR market?

Production of cost-effective generics with high efficacy and advancements in long-acting regimens are emerging technologies and trends in the COMBIVIR market[1][2].

Q5: Which region will dominate the COMBIVIR market?

North America is expected to dominate the COMBIVIR market during the forecast period[1].

Cited Sources

1. UnivDatos: Combivir Market: Current Analysis and Forecast (2023-2030)[1].
2. GSK: Getting ahead of HIV with ViiV Healthcare management[2].
3. BCC Research: Global Markets for Drug-Device Combinations[3].
4. FDA: COMBIVIR Label[4].