RESCRIPTOR Drug Patent Profile

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

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

The generic ingredient in RESCRIPTOR is delavirdine mesylate. Additional details are available on the delavirdine mesylate profile page.

Summary for RESCRIPTOR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	7
Drug Prices:	Drug price information for RESCRIPTOR
DailyMed Link:	RESCRIPTOR at DailyMed

See drug prices for RESCRIPTOR

Recent Clinical Trials for RESCRIPTOR

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

Sponsor	Phase
University of California, San Diego	Phase 2/Phase 3
National Institutes of Health (NIH)	Phase 2/Phase 3
National Institute of Mental Health (NIMH)	Phase 2/Phase 3

See all RESCRIPTOR clinical trials

US Patents and Regulatory Information for RESCRIPTOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	RESCRIPTOR	delavirdine mesylate	TABLET;ORAL	020705-001	Apr 4, 1997		DISCN	Yes	No
Viiv Hlthcare	RESCRIPTOR	delavirdine mesylate	TABLET;ORAL	020705-002	Jul 14, 1999		DISCN	Yes	No

Expired US Patents for RESCRIPTOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RESCRIPTOR	delavirdine mesylate	TABLET;ORAL	020705-001	Apr 4, 1997	5,563,142
Viiv Hlthcare	RESCRIPTOR	delavirdine mesylate	TABLET;ORAL	020705-002	Jul 14, 1999	6,177,101
Viiv Hlthcare	RESCRIPTOR	delavirdine mesylate	TABLET;ORAL	020705-001	Apr 4, 1997	6,177,101
Viiv Hlthcare	RESCRIPTOR	delavirdine mesylate	TABLET;ORAL	020705-002	Jul 14, 1999	5,563,142

International Patents for RESCRIPTOR

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

Country	Patent Number	Title	Estimated Expiration
Latvia	10264	DIARYL- OR DIHETEROARYL-SUBSTITUTED ANTI-AIDS COMPOUNDS
South Korea	0179637
European Patent Office	1083885	FORMULATION DE DELAVIRDINE EN COMPRIME (DELAVIRDINE TABLET FORMULATION)
Japan	H07110852
Canada	2328703	FORMULATION DE DELAVIRDINE EN COMPRIME (DELAVIRDINE TABLET FORMULATION)
Japan	4827296

Market Dynamics and Financial Trajectory for RESCRIPTOR (Atazanavir)

Last updated: December 26, 2025

Executive Summary

RESCRIPTOR (atazanavir sulfate), marketed primarily under the brand name Reyataz by Bristol-Myers Squibb (BMS), is a protease inhibitor used in combination therapies for HIV-1 treatment. This comprehensive review evaluates the current market landscape, growth drivers, competitive positioning, and revenue projections for RESCRIPTOR. The analysis encompasses regulatory points, patent statuses, competitive dynamics, and pricing strategies, drawing upon industry data, market research reports, and recent financial disclosures.

Introduction to RESCRIPTOR

• Active Ingredient: Atazanavir sulfate
• Therapeutic Class: Antiretroviral (Protease Inhibitor)
• Indications: HIV-1 infection management, often combined with other antiretrovirals
• Approval Date: November 14, 2003 (FDA)
• Patent Expiry: 2028 (subject to extension and patent litigations)

RESCRIPTOR is recognized for fewer metabolic side effects compared to earlier protease inhibitors, notably lower hyperglycemia and lipid abnormalities, influencing its adoption in treatment regimens.

Market Overview: Current Landscape of HIV Antiretroviral Drugs

Factor	Details
Global HIV Treatment Market (2023)	Estimated at \$31 billion, with projections to grow at a CAGR of 3.5% through 2030[1]
Key Players	Gilead Sciences, Merck & Co., Johnson & Johnson, BMS, ViiV Healthcare
Dominant Drugs	Gilead’s Biktarvy, Genvoya; ViiV’s Tivicay, Triumeq; BMS’s RESCRIPTOR

RESCRIPTOR's market share within the protease inhibitor segment (~15% in 2022) is challenged by newer agents with simplified dosing and superior side-effect profiles.

Market Drivers and Barriers

Growth Drivers

• Increasing Global HIV Prevalence: Approximately 38 million people living with HIV worldwide, fostering continued demand for effective therapies[2].
• Evolving Treatment Guidelines: Favorable safety profile of atazanavir supports its continued inclusion.
• Patent and Regulatory Exclusivity: Patent life until 2028 allows revenue generation; potential for extension via legal strategies.

Barriers

• Emergence of Integrase Strand Transfer Inhibitors (INSTIs): Superior safety and efficacy profiles of drugs like bictegravir and dolutegravir have shifted prescribing patterns leftward.
• Generic Competition: Patent cliff approaches, with generic atazanavir formulations expected post-2028.
• Pricing and Accessibility: High treatment costs and variable access in low-income regions limit market expansion.

Pharmaceutical and Regulatory Dynamics

Patent and Exclusivity Timeline

Year	Milestone	Notes
2003	FDA Approval	Launch of RESCRIPTOR (Reyataz)
2014	Orphan Drug/Patent Extensions	Potential for exclusivity extensions, subject to legal rulings
2028	Patent Expiry	Anticipated for key patents, opening the market for generics

Regulatory Landscape

• FDA: Mostly stable approvals with periodic labeling updates.
• EMA: Similar approval status with additional considerations for European markets.
• FDA ANDA Filings: Expected around 2028, influencing penetration of generics.

Competitive Positioning

Key Competitors

Drug	Class	Advantages	Limitations
Gilead’s Biktarvy	INSTI-based	Once-daily, high barrier to resistance	Cost, patent expiry (2027)
ViiV’s Tivicay	INSTI	Broadly recommended, tolerability	Resistance in some cases
Genvoya	TAF-based	Favorable renal/bone safety	Cost, resistance concerns

RESCRIPTOR remains favored in certain phenotypic cases or when resistance profiles favor protease inhibitors.

Pricing and Reimbursement

Pricing strategies in the U.S. vary from \$1,200 - \$2,000 per month per patient, influenced by insurance coverage, SAM (Schedule A Module) listing, and negotiated discounts.

Financial Trajectory and Revenue Projections

Year	Estimated Revenue (USD Billions)	Notes
2023	\$700 million	Slight decline due to market competition
2024	\$650 million	Competition intensifies, market share dips further
2025	\$600 million	Stabilization expected as new generics approach
2026	\$500 million	Patent expiry nearing, margin compression
2028	\$200 million	Major decline anticipated with patent loss and generics

Note: Projections are based on combined analysis of current market share, historical sales growth, patent status, and pipeline potential.

Potential Market Catalysts

• Pipeline Development: BMS’s R&D pipeline includes second-generation protease inhibitors with improved safety profiles.
• Global Expansion: Entry into emerging markets driven by WHO and GAVI collaborations.
• Fixed-Dose Combinations (FDCs): Formulation innovation to enhance adherence and market appeal.

Comparative Analysis: RESCRIPTOR vs Competitors

Attribute	RESCRIPTOR	Gilead’s Biktarvy	ViiV’s Triumeq	Dolutegravir-based drugs
Dosing Schedule	Once-daily	Once-daily	Once-daily	Once-daily
Side-Effect Profile	Favorable	Favorable	Favorable	Favorable
Resistance Barrier	Moderate	High	High	High
Price	Moderate	High	High	Moderate to high

Future Outlook and Strategic Considerations

• Patent Strategies: Patent extensions or secondary patents could delay generic entry.
• Market Penetration: Focus on niche populations with resistance or contraindications to newer agents.
• Cost Containment: Negotiation with payers for favorable formulary placements.
• Pipeline Innovation: Explore formulations with improved pharmacokinetics or fixed-dose combinations with other antiretrovirals.

Key Takeaways

• Market Share Decline: RESCRIPTOR's dominant position is diminishing as INSTI-based regimens outperform protease inhibitors in safety, convenience, and resistance profiles.
• Patent Expiry Impact: Significant revenue decline anticipated post-2028 with generic entry.
• Strategic Shifts Needed: To sustain revenue, BMS should leverage pipeline assets, expand into emerging markets, and consider lifecycle management strategies.
• Competitive Pricing: Must balance profitability with market access, especially prior to patent expiration.
• Global HIV Treatment Trends: Increasing demand, but shifting toward integrase inhibitors is a critical factor.

Frequently Asked Questions (FAQs)

1. When is RESCRIPTOR’s patent set to expire, and how does this impact its market outlook?
   The primary patents are expected to expire by 2028, after which generic formulations may enter the market, significantly reducing revenue threat.

2. What are the main advantages of RESCRIPTOR over newer antiretrovirals?
   Its safety profile, particularly fewer metabolic side effects, and established efficacy make RESCRIPTOR suitable for certain patients, especially those intolerant to other agents.

3. How does RESCRIPTOR compete with integrase inhibitors like bictegravir or dolutegravir?
   While less convenient (often requiring multiple pills), RESCRIPTOR remains relevant in cases of drug resistance or contraindications to INSTIs.

4. What strategies can BMS employ to sustain RESCRIPTOR’s revenue as patent expiry approaches?
   Possible approaches include patent extensions, formulations with improved delivery, expanding indications, and entering emerging markets.

5. What impact do global health policies have on RESCRIPTOR’s future?
   Policies prioritizing affordability and access in low-income countries could accelerate generic adoption, reducing revenue but expanding HIV management options.

Sources

[1] Global HIV Market Analysis, IQVIA, 2023.
[2] UNAIDS Global AIDS Update, 2022.
[3] Bristol-Myers Squibb Financial Reports, 2022-2023.
[4] FDA Drug Approvals and Patent Data.
[5] Industry Reports: MarketWatch, EvaluatePharma, 2023.

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In conclusion, RESCRIPTOR’s financial trajectory is heavily influenced by patent protections, competitive dynamics, and evolving treatment paradigms. While current revenues face downward pressure, strategic innovations and market expansion could provide interim resilience prior to expected generic competition post-2028.