REYATAZ Drug Patent Profile

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

Reyataz is a drug marketed by Bristol Myers Squibb and is included in two NDAs.

The generic ingredient in REYATAZ is atazanavir sulfate. There are twenty-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the atazanavir sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Reyataz

A generic version of REYATAZ was approved as atazanavir sulfate by TEVA PHARMS USA on April 22^nd, 2014.

Summary for REYATAZ

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	67
Patent Applications:	5,191
Drug Prices:	Drug price information for REYATAZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REYATAZ
What excipients (inactive ingredients) are in REYATAZ?	REYATAZ excipients list
DailyMed Link:	REYATAZ at DailyMed

See drug prices for REYATAZ

Recent Clinical Trials for REYATAZ

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

Sponsor	Phase
Acrotech Biopharma LLC	Phase 1
Axis Clinicals Limited	Phase 1
University of Turin, Italy	Phase 3

See all REYATAZ clinical trials

Pharmacology for REYATAZ

Drug Class	Protease Inhibitor
Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors UDP Glucuronosyltransferases Inhibitors UGT1A1 Inhibitors

Paragraph IV (Patent) Challenges for REYATAZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REYATAZ	Capsules	atazanavir sulfate	100 mg and 150 mg	021567	1	2010-03-19
REYATAZ	Capsules	atazanavir sulfate	200 mg	021567	1	2010-02-16
REYATAZ	Capsules	atazanavir sulfate	300 mg	021567	1	2009-07-20

US Patents and Regulatory Information for REYATAZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-001	Jun 20, 2003		DISCN	Yes	No
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-004	Oct 16, 2006	AB	RX	Yes	Yes
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-002	Jun 20, 2003		DISCN	Yes	No
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-003	Jun 20, 2003	AB	RX	Yes	No
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	POWDER;ORAL	206352-001	Jun 2, 2014		RX	Yes	Yes

Expired US Patents for REYATAZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-001	Jun 20, 2003
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	POWDER;ORAL	206352-001	Jun 2, 2014
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-003	Jun 20, 2003
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	POWDER;ORAL	206352-001	Jun 2, 2014
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-004	Oct 16, 2006

EU/EMA Drug Approvals for REYATAZ

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Reyataz	atazanavir sulfate	EMEA/H/C/000494Reyataz capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations).The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4.2).Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors ( 4 PI mutations). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).	Authorised	no	no	no	2004-03-01

International Patents for REYATAZ

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

Country	Patent Number	Title	Estimated Expiration
Germany	122005000003
Argentina	014417	LA SAL DE BISULFATO DEL ÉSTER DIMETíLICO DEL ÁCIDO[3S- (3R*, 8'R*, 9'R*, 12R*)] -3,12-BIS (1,1-DIMETILETIL) -8- HIDROXI-4,11- DIOXO-9- (FENILMETIL) -6- [[4-(2-PIRIDINIL) -FENILMETIL]] -2,5,6,10,13- PENTAAZATETRADECANODIOICO Y LA COMPOSICIoN FARMACÉUTICA QUE LA CONTIENE
Latvia	12522	BISULFATE SALT OF HIV PROTEASE INHIBITOR
Peru	01852000
New Zealand	509046	Intermediates in the formation of antivirally active heterocyclic azahexane derivatives

Supplementary Protection Certificates for REYATAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	2016C/066	Belgium		PRODUCT NAME: COBICISTAT ET ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025 20150715
2487163	132017000002807	Italy		PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E ATAZANAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE ATAZANAVIR SOLFATO(EVOTAZ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1025, 20150715
2487163	PA2016039	Lithuania		PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
0900210	CA 2005 00037	Denmark
2487163	1790002-8	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/15/1025, 2015-07-15

Market Dynamics and Financial Trajectory for REYATAZ (Tipranavir)

Last updated: January 17, 2026

Summary

Reyataz (tipranavir) is an antiretroviral protease inhibitor developed by Boehringer Ingelheim for the treatment of HIV-1. Since its FDA approval in 2005, Reyataz has established a notable position in the HIV therapeutics landscape owing to its unique formulation and efficacy profile. This analysis explores its current market position, competitive environment, regulatory landscape, and financial trajectory to assist stakeholders in strategic decision-making.

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What Are the Pharmacological and Clinical Attributes of Reyataz?

Reyataz (Tipranavir): An oral non-peptidic protease inhibitor (PI) that displays activity against multiple protease inhibitor-resistant strains of HIV-1.

Attribute	Details
Mechanism of Action	Inhibits the protease enzyme necessary for viral replication.
Formulation	Oral capsule (250 mg).
Indications	HIV-1 infection, in combination with other antiretroviral agents, for treatment-experienced patients.
Metabolism	Primarily hepatic (CYP3A4 pathway).
Dosing Regimen	500 mg twice daily, with ritonavir boosting.
Unique Features	Binds irreversibly to protease, active against resistant strains, requires a booster.

Note: FDA approval was granted in 2005; the drug has since become a component of salvage therapy for multi-drug resistant HIV cases.

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Market Ecosystem and Competition

Current Market Landscape

The global HIV therapeutics market was valued at approximately $30 billion in 2022 and is projected to grow at a CAGR of 4.2% through 2027, driven by increasing prevalence, evolving resistance profiles, and novel combination therapies.

Key Players (2023)	Market Share (%)	Notable Drugs
Gilead Sciences	~50%	Truvada, Descovy, Biktarvy
ViiV Healthcare	~25%	Tivicay, Juluca, Dovato
Johnson & Johnson/AbbVie	~10%	Prezista, Symtuza
Boehringer Ingelheim (Reyataz)	~3-5%	Reyataz
Others	Remaining	Multiple small or regional players

Reyataz’s niche lies primarily within salvage therapy and multi-drug resistant HIV infection, where it is favored for its potency against resistant strains.

Competitive Advantages

• Broad Resistance Profile: Effective against strains resistant to other PIs.
• Distinct Binding Mechanism: Binds irreversibly, offering a different resistance profile.
• Combination Compatibility: Suitable for use with other antiretrovirals.

Disadvantages:

• Formulation Limitations: Requires boosting with ritonavir.
• Adverse Effects: Higher incidence of hepatotoxicity and lipid abnormalities.
• Pricing: Premium pricing relative to generics, influencing market penetration.

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Regulatory and Policy Environment

Regulatory Status

Region	Status	Date
United States	FDA-approved (2005); Orphan drug designation	2005
European Union	EMA approved	2005
Japan	Approved	2006

Pricing and Reimbursement

• United States: Premium pricing (~$1,200/month), with coverage primarily through private insurers and Medicaid.
• Europe: Variably covered; managed under national reimbursement policies.
• Developing Markets: Limited penetration due to cost and availability constraints.

IP and Patent Landscape

• Original patents expired or nearing expiration in key markets, opening opportunities for generics in certain regions.
• No recent patent disputes reported, but secondary patents and formulation patents may extend exclusivity.

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Financial Trajectory and Revenue Analysis

Historical Revenue Performance

Year	Estimated Global Revenue (USD millions)	Growth (%)
2018	120	-
2019	115	-4.2%
2020	105	-8.7%
2021	90	-14.3%
2022	80	-11.1%

Revenue decline driven by multiple factors:

• Market Saturation: Dominance of integrase inhibitors such as Biktarvy.
• Generic Competition: Potential emergence after patent expiration.
• Shift in Treatment Paradigm: Towards less toxic, once-daily regimens with fewer side effects.

Forecasting Future Market Trends

• Moderate Growth in Niche Markets: Salvage therapy segments are expected to sustain Reyataz sales due to resistant strains’ treatment needs.
• Potential Decline Post-Patent Expiry: The expiration of core patents (anticipated around 2024-2026 in the US and Europe) may catalyze price erosion and market erosion.
• New Formulations and Combinations: Innovation could extend market lives, such as generic fixed-dose combinations (FDCs) or improved formulations with improved tolerability.

Projection Scenarios (2023-2028)	Conservative	Moderate	Aggressive
Revenue (USD millions)	75	90	110
Driver Impact	Market decline, patent cliff	Niche growth, combination innovations	Formulation improvements, expansion into emerging markets

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Market Entry and Growth Considerations

Aspect	Implication
Patent Expiry	Expected to open markets for generics post-2024 in US/Europe.
Pricing Strategy	Premium pricing in developed markets; potential for tiered pricing in emerging markets.
Partnership Opportunities	Licensing, co-promotion, and development of generic formulations.
Regulatory Pathways	Accelerated approvals for biosimilars or generics, especially in Asia.

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Deep Dive: Comparative Analysis with Similar Drugs

Attribute	Reyataz (Tipranavir)	Prezista (Darunavir)	Atazanavir (Reyataz)	Darunavir (Prezista)
Market Focus	Multi-resistant HIV prep	First-line therapy	Well-tolerated PI	First-line and salvage therapy
Resistance Profile	Broad, resistant strains	Strong resistance barrier	Moderate resistance	Very high barrier resistance
Formulation	Capsule	Capsule	Capsule	Capsule
Dosing	500mg BID + Ritonavir	800mg QD + Ritonavir	300mg QD + Ritonavir	800mg QD + Ritonavir
Pricing (USD/month)	~$1,200	~$1,200	~$950	~$1,100

Note: Darunavir generally confers better tolerability and resistance profile, which influences market preference.

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Key Market Challenges and Opportunities

Challenges

• Patent Expiration: Leading to increased risk of generic competition.
• Side Effect Profile: Lipid abnormalities and hepatotoxicity limit broader use.
• Pricing Pressures: Mid to low-income markets demand cost-effective alternatives.
• Market Saturation: Dominance of integrase inhibitors reduces application scope.

Opportunities

• Resistant HIV Strains: Growing need for salvage therapies supports niche demand.
• Innovative Formulations: Development of single-tablet regimens including Reyataz.
• Emerging Markets Penetration: Lower-cost generics could expand reach once patents expire.
• Combination Therapies: Co-formulation with other antiretrovirals sustains relevance.

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FAQs

1. What is the primary indication for Reyataz?
   Reyataz is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents, especially in treatment-experienced patients harboring resistant strains.

2. How does Reyataz differ from other protease inhibitors?
   Its unique irreversible binding mechanism allows activity against resistant HIV strains, differentiating it from other PIs with reversible binding profiles.

3. What are the main challenges facing Reyataz in the current market?
   Patent expiration risks, competition from newer agents with better tolerability, and pricing pressures are significant hurdles.

4. What is the forecasted impact of patent expiry on Reyataz's market?
   Post-patent expiry (expected around 2024-2026), generics are likely to erode brand revenues unless Boehringer Ingelheim develops new formulations or combinations.

5. Are there ongoing development efforts to improve Reyataz?
   While no new formulations have been officially announced, efforts in developing fixed-dose combinations and exploring biosimilar versions are possible trajectories.

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Key Takeaways

• Reyataz remains a critical resource in salvage HIV therapy, primarily due to its efficacy against resistant strains.
• The upcoming patent expiries threaten its market exclusivity, potentially leading to significant revenue decline.
• The drug’s niche positioning offers opportunities in resistant HIV treatment, especially if paired with innovation.
• Competitive dynamics favor integrase inhibitors and newer PIs with improved safety and dosing profiles.
• Strategic focus on developing combination therapies, expanding into emerging markets, and managing patent cliffs will shape Reyataz’s financial future.

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References

[1] World Health Organization. HIV/AIDS Data and Statistics, 2022.
[2] IQVIA. World Antiretroviral Market Report, 2023.
[3] Boehringer Ingelheim. Reyataz (Tipranavir) Prescribing Information, 2022.
[4] MarketsandMarkets. HIV Therapeutics Market Analysis, 2023.
[5] FDA. HIV Protease Inhibitors Approval History, 2005-2022.