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
National Institute of Mental Health (NIMH)	Phase 2/Phase 3
University of California, San Diego	Phase 2/Phase 3
National Institutes of Health (NIH)	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	020705-001	Apr 4, 1997	6,177,101
Viiv Hlthcare	RESCRIPTOR	delavirdine mesylate	TABLET;ORAL	020705-002	Jul 14, 1999	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
Japan	2002517430
New Zealand	508762	Delavirdine tablet formulation
Japan	H05503929
China	1301149
Denmark	0507861
Denmark	1083885
Germany	69934582

Market Dynamics and Financial Trajectory for RESCRIPTOR

Last updated: February 20, 2026

What is the current market landscape for RESCRIPTOR?

RESCRIPTOR (delavirdine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in HIV treatment. It was approved by the FDA in 1998 and marketed by ViiV Healthcare, a GSK subsidiary. Despite its established role, RESCRIPTOR's market presence has declined due to the rise of newer, more effective antiretrovirals with better safety profiles.

How has the market penetration evolved since approval?

• Initial Launch (1998-2002): RESCRIPTOR gained rapid adoption, primarily in combination therapies.
• Market Share Decline (2003-present): Entry of integrase inhibitors and second-generation NNRTIs reduced its prominence.
• Market Competition:
  • Efavirenz (Sustiva) and rilpivirine (Edurant) outperform RESCRIPTOR regarding efficacy and tolerability.
  • Fixed-dose combinations (FDCs) now dominate the HIV treatment landscape, diminishing standalone NNRTI demand.

What are the key determinants of its current and future market dynamics?

Patent Status and Generic Competition

• Patent expiry: The original patent expired in 2016.
• Legal challenges and generic entries: Multiple generics entered the market post-2016, causing price erosion.

Efficacy and Safety Profile

• RESCRIPTOR's efficacy is comparable to other NNRTIs, but it has a less favorable side effect profile, including rash and hepatotoxicity.
• The advent of integrase inhibitors has shifted clinicians toward therapies with fewer drug interactions and side effects.

Regulatory Landscape and Off-Label Uses

• The drug has no recent regulatory incentives.
• Limited off-label applications curtail additional revenue streams.

Market Size and Forecast

• The global antiretroviral therapy (ART) market was valued at approximately $25.8 billion in 2021 [1].
• RESCRIPTOR’s segment is a small fraction, mainly driven by existing prescriptions and off-label use.

Revenue Trends

• Historical revenue: At peak, RESCRIPTOR generated hundreds of millions annually.
• Recent figures: Sales have declined sharply since 2016, with estimates around $20 million in 2022, primarily from legacy use and generic sales [2].

How is the pharmaceutical pipeline affecting RESCRIPTOR?

• Newer drugs like islatravir and doravirine show promise as replacement options.
• ViiV Healthcare has shifted focus toward innovative therapies for HIV, reducing R&D investment in older NNRTIs like RESCRIPTOR.

What is the outlook for RESCRIPTOR’s financial trajectory?

Factor	Impact	Outlook
Patent expiry	Negative	Continued generic erosion expected
Market demand	Declining	No significant rebound anticipated
Clinical positioning	Static	Obsolescence likely without reformulation
R&D investment	Low	Limited potential for revitalization

Projected revenues from RESCRIPTOR are expected to decline below $10 million annually within the next two years, with remaining sales primarily from legacy patients and batch stocks.

What are the strategic implications for stakeholders?

• Investors should recognize RESCRIPTOR as a declining asset with limited upside.
• Pharmaceutical companies have phased out R&D efforts toward RESCRIPTOR, favoring next-generation therapies.
• Market entrants targeting HIV will prioritize drugs with improved efficacy, tolerability, and dosing convenience.

Key takeaways

• RESCRIPTOR’s market presence diminishes due to patent expiration, generic competition, and evolving treatment standards.
• The drug’s push toward obsolescence is reinforced by newer drugs offering better safety profiles and simplified regimens.
• Revenues are forecasted to decline sharply, with minimal recovery prospects unless reformulated or repositioned.

FAQs

1. What caused the decline in RESCRIPTOR's market share?
The introduction of newer antiretroviral agents with superior safety and efficacy profiles, combined with patent expiration and generic competition, caused the decline.

2. Is RESCRIPTOR still under patent protection?
No. Its primary patent expired in 2016, leading to generic versions entering the market.

3. Can RESCRIPTOR regain market share?
Unlikely, given the availability of better-tolerated and more effective drugs and the shift to combination therapies.

4. What are the primary competitors of RESCRIPTOR?
Efavirenz (Sustiva), rilpivirine (Edurant), and newer integrase inhibitors like dolutegravir.

5. What is the future outlook for RESCRIPTOR’s revenues?
Revenues are expected to continue shrinking below the $10 million mark within two years, with limited prospects for significant revival.

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References

[1] Grand View Research. (2022). Antiretroviral Therapy Market Size, Share & Trends.
[2] IQVIA. (2022). Monthly Global/IQVIA Revenue Reports.
[3] U.S. Food and Drug Administration. (2016). Patent and Exclusivity Data.