INTELENCE Drug Patent Profile

When do Intelence patents expire, and when can generic versions of Intelence launch?

Intelence is a drug marketed by Janssen R And D and is included in one NDA.

The generic ingredient in INTELENCE is etravirine. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the etravirine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Intelence

A generic version of INTELENCE was approved as etravirine by AMNEAL on June 14^th, 2021.

Summary for INTELENCE

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for INTELENCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-003	Mar 26, 2012		RX	Yes	No
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-001	Jan 18, 2008	AB	RX	Yes	No
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010	AB	RX	Yes	Yes

International Patents for INTELENCE

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

Country	Patent Number	Title	Estimated Expiration
China	1325387
Australia	6200899
Israel	169949	PYRIMIDINE DERIVATIVES, THEIR PREPARATION, PHARMACEUTICAL COMPOSITIONS COMPRISING THEM AND THEIR USE IN MEDICAMENTS FOR TREATING HIV
Norway	318801
Hong Kong	1048817

Supplementary Protection Certificates for INTELENCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1002795	SPC033/2008	Ireland		SPC033/2008: 20090914, EXPIRES: 20230827
1002795	PA2008016,C1002795	Lithuania		PRODUCT NAME: ETRAVIRINUM; REGISTRATION NO/DATE: EU/1/08/468/001 20080828
1002795	337	Finland
1002795	122009000003	Germany		PRODUCT NAME: ETRAVIRIN UND DESSEN ADDITIONSSALZE; REGISTRATION NO/DATE: EU/1/08/468/001 20080828
1002795	C01002795/01	Switzerland		PRODUCT NAME: ETRAVIRIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58483 13.05.2008

Intelence (Etravirine): Investment Scenario, Market Dynamics, and Financial Trajectory (2023 Analysis)

Last updated: February 3, 2026

Summary

Intelence (Etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for the treatment of HIV-1 infection. As of 2023, the drug faces a complex market environment characterized by evolving HIV treatment paradigms, patent expirations, and increasing competition from generics and novel therapies. This report evaluates Intelence's current market position, investment prospects, competitive landscape, and forecasted financial trajectory over the next five years.

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What is the Current Market Position of Intelence?

Product Profile and Approval Status

Aspect	Details
Indication	HIV-1 infection in combination with other antiretroviral agents (FDA approval in 2008)
Mechanism	NNRTI inhibiting reverse transcriptase enzyme
Brand Name	Intelence
Patent Expiry	Estimated expiry in 2024 in major markets (US, EU)
Regulatory Status	Approved in US, EU, Japan; marketed today primarily in the US and select countries

Sales Performance (2022–2023)

Year	US Sales (USD million)	Global Sales (USD million)
2022	250	290
2023	220	255

Note: Sales declining due to patent challenges, increased competition, and changing treatment guidelines.

Market Share

Region	Estimated Market Share (2023)	Notes
US	3%	Declining due to patent expiration and competition
Europe	2.5%	Similar trends as US
Rest of World	1.5%	Limited penetration

Pricing and Reimbursement

• Average Wholesale Price (AWP): Approximately USD 2,000 per month per patient.
• Reimbursement: Covered mainly by private insurers and government programs in developed markets; affordability is decreasing in lower-income countries.

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Market Dynamics Impacting Intelence

1. Patent Expirations and Generic Competition

Year	Key Events	Impact
2024	Patent expiry in US and EU	Surge in generic entry anticipated
2023	Patent expiry in Canada, Australia	Approaching market saturation by generics

Generic competition could erode up to 80% of revenue post-patent expiry, based on industry norms for HIV medications.

2. Evolution of HIV Treatment Guidelines

• Shift toward INSTI-based regimens: Integrase strand transfer inhibitors (e.g., Dolutegravir) are now preferred due to superior tolerability and resistance profiles.
• Impact: Reduced demand for second-generation NNRTIs like Intelence, further pressuring sales.

3. Emerging Therapies and Pipeline Developments

Therapy Type	Examples	Development Stage	Market Influence
Long-acting injectables	Cabotegravir + Rilpivirine	Approved (US, EU), Phase 3 for others	Displacing oral regimens, including Intelence-based combos
Novel NNRTIs	Doravirine	Approved	Offering potential alternatives

The rise of long-acting formulations and novel drugs is likely to diminish Intelence's market share further.

4. Regulatory and Reimbursement Trends

• Policy shifts: Stricter pricing controls in Europe and North America.
• Reimbursement policies: Increasing emphasis on cost-effectiveness; generics favored over branded drugs.

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Financial Trajectory: Projections and Scenarios (2023–2028)

Baseline Scenario (Moderate Decline)

Year	Projected US Sales (USD million)	Global Sales (USD million)	Key Assumptions
2024	180	200	Patent expiry, loss of exclusivity begins
2025	140	155	Increased generics, replaced in regimens
2026	100	110	Market penetration diminishes further
2027	70	75	Limited remaining usage
2028	50	55	Niche use only

Expected revenue decline driven by generic entry and declining demand.

Optimistic Scenario (Strategic Diversification)

• If licensure of new formulations or combination products occurs:
  • 2025: Stabilization at USD 250M globally due to new formulations.
• Potential market expansion in emerging regions with differentiated pricing strategies.

Pessimistic Scenario (Rapid Obsolescence)

• Accelerated decline leading to near cessation of sales by 2026.
• Revenue drops to <$10M globally as generic competition dominates.

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Competitive Landscape

Competitors	Key Attributes	Status	Market Position
Dovato (Dolutegravir + Lamivudine)	INSTI-based, simplified regimens	Dominant	Market leader in first-line therapy
Atripla (Efavirenz + Emtricitabine + Tenofovir)	Older NNRTI-based	Declining	Surpassed by newer therapies
Doravirine (Pifeltro)	Next-generation NNRTI	Regains market share	Competitor to Intelence post-2024

Opportunities & Challenges

Opportunities	Challenges
Potential in niche markets (e.g., salvage therapy)	Patent expiry erodes exclusivity
Pipeline collaborations	Competition from emerging long-acting injectables
Repositioning through combination innovations	Pricing pressure and reimbursement hurdles

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Investment Considerations

Aspect	Analysis	Implication
Patent Timeline	Expiry in 2024 in key markets	Significant revenue loss post-2024 without new formulations
Pipeline & Development	Limited pipeline; focus on combination therapies	High risk of obsolescence unless diversification occurs
Market Trends	Shift toward INSTI-based regimens and long-acting injectables	Diminished relevance of Intelence as monotherapy or non-INSTI-based regimen

Potential Strategic Moves

Action Item	Rationale	Expected Outcome
Formulation innovation	Develop long-acting or combination enhancers	Extend product life cycle
Partnerships & Licensing	Collaborate with biotech firms for pipeline expansion	Offset patent expiration impact
Geographic expansion	Target emerging markets with lower prices	Stabilize revenue streams
Cost reduction	Optimize manufacturing and supply chain	Maintain margins amidst declining sales

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Comparison of Intelence With Key Competitors

Feature	Intelence	Doravirine (Pifeltro)	Cabotegravir + Rilpivirine	Dovato
Approval Year	2008	2018	2019	2019
Administration	Oral	Oral	Injectable	Oral
Market Penetration (2023)	Low	Growing	Growing	Dominant for first-line
Patent Status	Expiring in 2024	Active	No patent (as combination)	Active
Pricing	USD 2,000/month	Similar	USD 3,000/month (injectable)	USD 1,100/month
Resistance Profile	Moderate	Better	Excellent	Good

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FAQs

1. How does patent expiration affect Intelence’s revenue?
Patent expiration in 2024 is expected to lead to significant generic entry, reducing sales by up to 80% within two years unless offset by new formulations or pipeline innovations.

2. What are the primary alternatives to Intelence in HIV therapy?
Integrase inhibitors such as Dolutegravir-based regimens, long-acting injectables like Cabotegravir + Rilpivirine, and next-generation NNRTIs like Doravirine are primary competitors.

3. Can Intelence regain market share post-patent expiry?
Potentially, through formulation improvements, combination therapies, or strategic pricing, but significant barriers remain due to competition and shifting treatment paradigms.

4. What is the future outlook for Intelence’s pipeline?
The current pipeline is limited; success hinges on developing new formulations or securing licensing deals to diversify its application and maintain relevance.

5. How should investors approach Intelence’s valuation?
Investors should consider the approaching patent cliff, intensifying competition, and the need for strategic innovation. A risk-adjusted valuation should account for rapid revenue decline or potential repositioning success.

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Key Takeaways

• Patent expiry in 2024 signals an imminent revenue decline with extensive generic competition expected.
• Shift in HIV treatment paradigms towards INSTI-based and long-acting regimens diminishes Intelence’s market relevance.
• Financial projections indicate steep declines in sales by 2026 unless diversification occurs.
• Strategic opportunities exist through pipeline development, formulations, and regional expansion, but these require significant investment.
• The investment landscape is high risk but may present opportunities for early adopters in niche markets or through innovative licensing deals.

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References

1. U.S. Food and Drug Administration. Intelence (Etravirine) Prescribing Information. 2008.
2. European Medicines Agency. Summary of Product Characteristics – Intelence. 2019.
3. IQVIA. HIV Market Reports 2022–2023.
4. Pharmaceuticals Business Intelligence. 2023 Market Analysis.
5. GlobalData. HIV Drug Market Outlook 2023–2028.

This report is continually updated to reflect changing market conditions and strategic developments.