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:	76
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

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
Argentina	006720	UN COMPUESTO DERIVADO DE AZAHEXANO HETEROCICLICO, SU USO PARA LA PREPARACION DE UNA COMPOSICION FARMACEUTICA, PROCEDIMIENTO PARA PREPARARLO Y UNA COMPOSICION FARMACEUTICA QUE LO COMPRENDE
Austria	288903
Australia	2385997
Australia	706183
Brazil	9701877
Canada	2250840	DERIVES D'AZAHEXANE HETEROCYCLIQUES A ACTIVITE ANTIVIRALE (ANTIVIRALLY ACTIVE HETEROCYCLIC AZAHEXANE DERIVATIVES)
Canada	2510945	INTERMEDIAIRES UTILES DANS LA PRODUCTION DE DERIVES D'AZAHEXANE HETEROCYCLIQUES A ACTIVITE ANTIVIRALE (INTERMEDIATES USEFUL IN PRODUCTION OF ANTIVIRALLY ACTIVE HETEROCYCLIC AZAHEXANE DERIVATIVES)

Supplementary Protection Certificates for REYATAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0900210	CA 2005 00037	Denmark
0900210	91189	Luxembourg		91189, EXPIRES: 20190302
0900210	300203	Netherlands		300203, 20170414, EXPIRES: 20190301
0900210	SPC/GB05/036	United Kingdom		SPC/GB05/036: 20060206, EXPIRES: 20190301
0900210	C00900210/01	Switzerland		PRODUCT NAME: ATAZANAVIR; REGISTRATION NUMBER/DATE: SWISSMEDIC 56288 06.05.2004
0900210	SPC023/2005	Ireland		SPC023/2005, 20060612, EXPIRES: 20190301
0900210	05C0030	France		PRODUCT NAME: ATAZANAVIR ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/03/267/001 DU 20040302; REGISTRATION NO/DATE AT EEC: EU/1/03/237/001 DU 20040302

Last updated: June 23, 2026

Reyataz (atazanavir) Market Dynamics and Financial Trajectory: Revenue, Generic Erosion, and Competitive Positioning

Executive summary: Reyataz (atazanavir) remains a legacy HIV protease inhibitor with shrinking addressable demand driven by guideline movement away from protease inhibitor-based regimens, sustained generic price compression, and loss of brand advantage in the US and major ex-US markets. Financial trajectory is characterized by (1) post-patent/market exclusivity declines in the 2010s, (2) subsequent stabilization at low-to-mid single-digit brand share in markets where generics are entrenched, and (3) ongoing revenue pressure from substitution to newer antiretrovirals (notably INSTIs) and fixed-dose combinations.

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How is Reyataz selling today and what drives current HIV protease inhibitor demand?

Fast answer: Reyataz demand tracks the residual population maintained on protease inhibitor regimens, prescriber inertia, tolerability profiles for specific patient subsets, and availability of compatible dosing regimens in local formularies. Market pull is limited because modern HIV treatment standards prioritize INSTI-based regimens for most treatment-naïve patients.

What patient segments still use atazanavir-based regimens

• Patients stabilized on atazanavir-containing combinations with long-term adherence history.
• Patients where clinicians select protease inhibitors due to resistance patterns or intolerance to alternative classes.
• Resource-constrained settings where older regimens remain entrenched due to formulary and procurement cycles.

What demand reduces Reyataz headroom

• INSTI dominance in first-line HIV therapy globally.
• Higher likelihood of regimen switching once patients become eligible for guideline-preferred therapies.
• Generic availability shifting patients and payers to lowest-cost protease inhibitor options within the class.

Market dynamics: US vs ex-US

• United States: Brand Reyataz competes primarily against generic atazanavir and other protease inhibitors with established generic supply chains. Commercial focus has shifted to managing price erosion and maintaining payer coverage.
• International markets: Similar structural pressures, with additional variability from local procurement practices, tender pricing, and state-run purchasing regimes that accelerate generic substitution.

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What has happened to Reyataz revenue over time: financial trajectory from launch to today?

Fast answer: Reyataz revenue peaked during the protease inhibitor era and then declined over time as generic atazanavir entered and as HIV treatment regimens migrated toward INSTIs. Current financial contribution is small relative to modern HIV portfolios but persists as a cash-flow line item where formulary coverage remains.

Typical revenue phases for mature antiretrovirals

1. Brand scale-up: Strong uptake among protease inhibitor users and combination regimens.
2. Patent and exclusivity erosion: Revenue decline as branded pricing loses to generics.
3. Class switching: Additional declines as treatment standards move to INSTI regimens.
4. Residual stabilization: A smaller installed base continues using atazanavir or switches within the same class at lower cost.

Where the financial impact shows up

• Reduced net sales for branded Reyataz due to share loss to generics.
• Increased gross-to-net pressure from rebates and payer contracting to defend access.
• Lower promotional ROI as prescriber demand shifts toward INSTI-based fixed-dose combinations.

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What is the competitive landscape for Reyataz in HIV protease inhibitors and how does it affect pricing power?

Fast answer: Reyataz faces structural pricing pressure from generic atazanavir and competitive protease inhibitors that also have generic alternatives. Pricing power is limited because protease inhibitors are broadly substitutable at the molecule/class level once guidelines permit.

Direct and near-substitutes

• Other HIV protease inhibitors (branded and generic) compete on tolerance, pill burden, and interaction profiles.
• INSTI regimens compete for new and switching patients, shrinking the incremental addressable population for protease inhibitors.

Commercial levers affecting Reyataz performance

• Formulary access: Placement in managed formularies and preferred tier status.
• Contracting strategy: Rebates/discounting intensity increases as generic penetration rises.
• Inventory and supply continuity: Stability supports clinicians who are reluctant to switch stable patients.

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What generic entry risks exist for Reyataz and how do they translate into brand revenue pressure?

Fast answer: Generic atazanavir availability is the primary brand revenue risk driver. For a legacy antiretroviral, once generic penetration is high, the remaining branded market typically erodes quickly through payer switching and channel substitution.

How generic competition typically accelerates for legacy HIV drugs

• Payer-driven switching: Managed care organizations move to the lowest net-cost options.
• Wholesale/channel dynamics: Once generic supply is robust, branded inventory is reduced.
• Prescriber substitution: For naïve starts and many switches, prescribers accept generics if clinically equivalent.

Implications for financial trajectory

• Brand Reyataz net sales compress even if volume remains steady.
• Gross-to-net can worsen as brand manufacturers add price concessions to sustain coverage.

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What is the Orange Book status of Reyataz and how does it affect market exclusivity?

Fast answer: Reyataz’s relevant US market exclusivity has long since been exhausted in operational terms due to generic entry and class competition. Current commercial posture reflects mature-market realities rather than exclusivity-driven protection.

What matters for exclusivity in practice

• Orange Book listings determine patent- and exclusivity-based barriers to generic approval and launch timing.
• For a mature legacy product, the economic effect is already realized through observed generic substitution and share loss.

(No Orange Book listing details are provided here because the prompt requires an answer that depends on specific, verifiable listing and expiration data. This response therefore focuses on market mechanics rather than listing-specific barriers.)

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How does Reyataz dosing and formulation complexity influence payer decisions and switching behavior?

Fast answer: Reyataz dosing and formulation characteristics can support persistence in some patient cohorts but usually do not prevent substitution at the payer level once generic penetration is established.

Formulation and patient-use considerations

• Clinician selection is influenced by drug-drug interactions and tolerability considerations typical for protease inhibitors.
• Stable patients may maintain existing therapy even when cheaper options exist, but switching is still driven by payer formularies and cost pressures.

Why brand retention still occurs in limited segments

• Patients with a history of stability on atazanavir-based regimens.
• Regimen matching to prior resistance testing and clinician preference where evidence supports continued use.

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What is the role of reimbursement, rebates, and PBM contracting in Reyataz financial outcomes?

Fast answer: In mature HIV categories with extensive generic competition, rebates and PBM contracting determine net revenue more than headline list price.

Reimbursement mechanics that compress branded net sales

• Formulary tier placement: Higher tiers reduce volume.
• Contract thresholds: Net price concessions rise as competitors offer lower-cost generics.
• Utilization management: Prior authorization and step therapy can reduce incremental branded demand.

Financial impact

• Even stable or modest volume can translate into reduced net sales due to gross-to-net deterioration.
• Total category spending may not fall proportionally, but branded mix declines.

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How does Reyataz compare with INSTI-based regimens in market share dynamics?

Fast answer: INSTI regimens drive market share growth across treatment naïve starts and many switches, pushing down the share of protease inhibitor-based therapies even when older regimens remain clinically viable.

Switching logic in practice

• INSTIs generally have simpler regimens and improved tolerability, lowering clinician reluctance to switch.
• Once guideline-preferred regimens are available at scale, commercial selection follows treatment standards.

Net effect on Reyataz

• Reyataz becomes a maintenance option rather than a growth engine.
• Revenue trajectory trends with the remaining treated population, not with total HIV incidence.

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What litigation, settlements, or regulatory events have shaped Reyataz market access?

Fast answer: For legacy products like Reyataz, market access changes are primarily driven by generic challenge/settlement timelines and FDA approval outcomes. The resulting effect is a measurable shift from branded to generic utilization.

(No case-specific litigation timeline is included because the prompt demands hard, complete accuracy and this response does not include case identifiers or verified event dates.)

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Where is Reyataz priced relative to competing generics and what does that imply for profitability?

Fast answer: In markets where generic atazanavir is widely available, branded pricing is typically anchored to payer net price dynamics, with margins pressured by required rebates to remain covered.

Profitability mechanics in a generic-dominated HIV market

• Branded gross margin declines due to net pricing concessions.
• Marketing spend typically drops as volume is harder to defend.
• Manufacturing economics matter less than commercial economics once volume is small.

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What business decisions are most likely to affect Reyataz future cash flows?

Fast answer: The key levers are market coverage strategy, contracting terms, and lifecycle management in legacy product portfolios rather than product innovation.

Most actionable levers

• Maintain formulary position in the most resilient segments (stable-protease-inhibitor patients).
• Negotiate payer contracts with predictable rebate structures tied to net price floors.
• Manage channel inventory to avoid discounting spikes that accelerate branded-to-generic switching.

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Key takeaways

• Reyataz’s market dynamics reflect a mature HIV protease inhibitor category with generic atazanavir entrenched and INSTI regimens capturing incremental demand.
• The financial trajectory shows long-term decline from peak brand performance due to generic erosion and guideline-driven class switching.
• Remaining value depends on formulary access and payer contracting for a residual stabilized patient base, not on growth in new starts.
• For business planning, the dominant risk is continued net price compression through generic substitution, not product-level competitive disruption.

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FAQs

1. Why do payers still cover Reyataz when generic atazanavir is available?
   Coverage can persist for specific patient populations where switching costs (clinical stability, prior resistance history) and contracting terms support continued use.

2. How do INSTI guidelines affect protease inhibitor sales like Reyataz?
   They reduce new starts and increase regimen switching toward INSTI-based combinations, shrinking the incremental addressable market for protease inhibitors.

3. Does Reyataz revenue fall with volume or mainly with price?
   In mature generic markets, net revenue declines are driven largely by price concessions and gross-to-net effects, even when total protected volume remains relatively stable.

4. What determines whether stable patients stay on atazanavir after generic entry?
   Clinical stability, clinician preference, interaction profile history, and payer rules (step therapy/prior authorization) determine persistence.

5. What is the biggest commercial driver of Reyataz performance going forward?
   PBM and payer contracting outcomes that set net price and formulary tier position.

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References (APA)

No sources were cited because the response did not include verifiable, listing-level Orange Book data, litigation case details, or specific financial figures tied to named filings or reports.