VIVITROL Drug Patent Profile

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

Vivitrol is a drug marketed by Alkermes and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in eleven countries.

The generic ingredient in VIVITROL is naltrexone. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the naltrexone profile page.

DrugPatentWatch^® Generic Entry Outlook for Vivitrol

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (naltrexone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for VIVITROL

International Patents:	18
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	83
Patent Applications:	4,888
Drug Prices:	Drug price information for VIVITROL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIVITROL
What excipients (inactive ingredients) are in VIVITROL?	VIVITROL excipients list
DailyMed Link:	VIVITROL at DailyMed

See drug prices for VIVITROL

See drug sales revenues for VIVITROL

Recent Clinical Trials for VIVITROL

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

Sponsor	Phase
Inventage Lab., Inc.	Phase 1
Baylor College of Medicine	Phase 3
University of Texas Southwestern Medical Center	Phase 2

See all VIVITROL clinical trials

Paragraph IV (Patent) Challenges for VIVITROL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIVITROL	Extended-release Injectable Suspension	naltrexone	380 mg/vial	021897	1	2020-06-18

US Patents and Regulatory Information for VIVITROL

VIVITROL is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006		RX	Yes	Yes

Expired US Patents for VIVITROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006

International Patents for VIVITROL

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

Country	Patent Number	Title	Estimated Expiration
Austria	363891
Cyprus	1110403
World Intellectual Property Organization (WIPO)	0191720
Czech Republic	293578	Způsob přípravy a použití biodegradovatelných biokompatibilních mikročástic (Process for preparing and use of biodegradable, biocompatible microparticles)

Supplementary Protection Certificates for VIVITROL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	2017/059	Ireland		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456	LUC00054	Luxembourg		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456	SPC/GB17/078	United Kingdom		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330

VIVITROL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VIVITROL

Introduction

VIVITROL, a medication developed by Alkermes, has been a significant player in the treatment of alcohol and opioid dependence. Here, we delve into the market dynamics and financial trajectory of VIVITROL, highlighting its growth, challenges, and future prospects.

Approval and Initial Market Presence

VIVITROL was first approved by the FDA in 2006 for the treatment of alcohol dependence and later in 2010 for opioid dependence. Initially, the drug was marketed through a collaboration with Cephalon, but Alkermes regained full commercialization rights in December 2008[3].

Marketing and Lobbying Efforts

Alkermes' aggressive marketing and lobbying efforts have been instrumental in VIVITROL's success. The company has invested heavily in building name recognition and driving sales, which has led to significant growth. By 2016, Alkermes' national political contributions and lobbying outlays had reached $4.5 million, contributing to high-profile endorsements and increased adoption in various programs[1].

Sales Growth and Projections

VIVITROL's sales have seen a remarkable upward trend. From $209 million in 2016, sales were forecasted to reach $280-300 million in 2017 and were projected to exceed $1 billion by 2021[1]. In the third quarter of 2023, VIVITROL's net sales stood at $99.3 million, a 3% increase from the same period in the prior year[2].

Current Financial Performance

As of the fourth quarter of 2023, VIVITROL's annual net sales were $400.4 million, with expectations for 2024 set between $410 and $430 million. This consistent growth reflects the drug's established presence in the market[5].

Market Penetration and Utilization

VIVITROL is now used in over 450 programs across 39 states, including public health initiatives, drug courts, prisons, and jails. This widespread adoption is a key indicator of the drug's sustained growth and acceptance among healthcare providers and patients[1].

Competitive Landscape

The naltrexone and buprenorphine market, in which VIVITROL operates, is projected to grow at a CAGR of 12.41% from 2024 to 2030. This growth is driven by increasing prevalence of substance use disorders, government initiatives, and rising awareness of opioid use disorder treatment. Alkermes faces competition from other players like Indivior PLC, which is expanding its market presence with new formulations[4].

Regional Market Dynamics

• North America: This region accounts for a significant share of the naltrexone and buprenorphine market, driven by high awareness among healthcare experts and favorable reimbursement policies[4].
• Europe: The market here is influenced by healthcare reforms, research advancements, and patient-focused initiatives. Countries like the UK and France are seeing significant growth due to increasing prevalence of substance use disorders[4].
• Latin America and Japan: These regions are also experiencing growth, driven by healthcare policies, regulatory environments, and demographic factors such as an aging population[4].

Challenges and Controversies

Despite its success, VIVITROL has faced scrutiny due to its high cost, with each shot priced over $1,000, compared to generic naltrexone which is significantly cheaper. This pricing has led to public and political scrutiny, particularly in the context of the opioid epidemic[1].

Future Prospects

Alkermes continues to focus on high-impact activities to increase VIVITROL sales, including improving physician utilization, streamlining product access and reimbursement, and enhancing continuity of care for patients. The company's financial expectations for 2024 indicate continued growth, with total revenues projected between $1,500 and $1,600 million[5].

Key Strategies

• Enhancing Physician Utilization: Alkermes is working to increase the number of physicians prescribing VIVITROL.
• Streamlining Access and Reimbursement: Efforts are being made to simplify the process of accessing and reimbursing the drug.
• Continuity of Care: The company is focusing on ensuring seamless care for patients transitioning between treatment settings[3].

Financial Expectations for 2024

Alkermes expects VIVITROL net sales to range between $410 and $430 million in 2024. Total revenues are projected to be between $1,500 and $1,600 million, with non-GAAP net income expected to be between $465 and $505 million[5].

Conclusion

VIVITROL has established itself as a leading treatment for alcohol and opioid dependence, driven by robust marketing and lobbying efforts. Despite challenges related to its high cost, the drug continues to see significant growth and adoption. As the global naltrexone and buprenorphine market expands, VIVITROL is well-positioned to maintain its market share and contribute to Alkermes' financial success.

Key Takeaways

• Strong Sales Growth: VIVITROL's sales have consistently increased, with projections exceeding $1 billion.
• Widespread Adoption: The drug is used in over 450 programs across 39 states.
• Market Expansion: The global naltrexone and buprenorphine market is growing at a CAGR of 12.41% from 2024 to 2030.
• Challenges: High cost and public scrutiny remain challenges.
• Future Prospects: Continued focus on physician utilization, access, and continuity of care is expected to drive growth.

FAQs

Q: What is VIVITROL used for? A: VIVITROL is used for the treatment of alcohol dependence and opioid dependence.

Q: How much does VIVITROL cost? A: Each shot of VIVITROL is priced over $1,000, significantly higher than generic naltrexone.

Q: What are the key factors driving the growth of VIVITROL? A: Key factors include aggressive marketing and lobbying, increasing prevalence of substance use disorders, and favorable reimbursement policies.

Q: How many programs use VIVITROL across the U.S.? A: VIVITROL is used in over 450 programs across 39 states.

Q: What are Alkermes' financial expectations for VIVITROL in 2024? A: Alkermes expects VIVITROL net sales to range between $410 and $430 million in 2024, with total revenues projected between $1,500 and $1,600 million.

Sources

1. FiercePharma - Alkermes' Vivitrol marketing and lobbying put it under gun
2. PR Newswire - Alkermes plc Reports Third Quarter 2023 Financial Results
3. Alkermes Investor Relations - Alkermes Regains Full Commercialization Rights to VIVITROL(R) in U.S.
4. Grand View Research - Naltrexone And Buprenorphine Market Size Report, 2030
5. PR Newswire - Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2023, and Provides Financial Expectations for 2024