EVOTAZ Drug Patent Profile

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

Evotaz is a drug marketed by Bristol and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and six patent family members in forty-one countries.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atazanavir sulfate; cobicistat profile page.

DrugPatentWatch^® Generic Entry Outlook for Evotaz

Evotaz was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 3, 2029. This may change due to patent challenges or generic licensing.

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for EVOTAZ

International Patents:	306
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Patent Applications:	68
Drug Prices:	Drug price information for EVOTAZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVOTAZ
What excipients (inactive ingredients) are in EVOTAZ?	EVOTAZ excipients list
DailyMed Link:	EVOTAZ at DailyMed

See drug prices for EVOTAZ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EVOTAZ

Constraining patent/regulatory exclusivity:

8,148,374

NDA:

206353

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EVOTAZ

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

Sponsor	Phase
Gilead Sciences	Phase 3
St Stephens Aids Trust	Phase 1
Bristol-Myers Squibb	Phase 1

See all EVOTAZ clinical trials

Pharmacology for EVOTAZ

Drug Class

Cytochrome P450 3A Inhibitor Protease Inhibitor

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors UDP Glucuronosyltransferases Inhibitors UGT1A1 Inhibitors

Paragraph IV (Patent) Challenges for EVOTAZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EVOTAZ	Tablets	atazanavir sulfate; cobicistat	300 mg/150 mg	206353	1	2017-09-13

US Patents and Regulatory Information for EVOTAZ

EVOTAZ is protected by two US patents.

This potential generic entry date is based on patent 8,148,374.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015		RX	Yes	Yes	8,148,374		Y	Y
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015		RX	Yes	Yes	10,039,718		Y

International Patents for EVOTAZ

When does loss-of-exclusivity occur for EVOTAZ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Croatia

Cyprus

Denmark

European Patent Office

Finland

France

Hong Kong

Israel

Japan

Lithuania

Mexico

Montenegro

Netherlands

New Zealand

Norway

Poland

Portugal

Slovenia

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EVOTAZ around the world.

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	3089
African Regional IP Organization (ARIPO)	3250
Argentina	075369
Australia	2009242451
Australia	2010210598
Australia	2014221210

Supplementary Protection Certificates for EVOTAZ

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

Last updated: July 20, 2026

EVOTAZ (atazanavir sulfate/cobicistat) market dynamics and financial trajectory: exclusivity, competitive threats, pricing, and sales outlook

EVOTAZ generates revenue as a branded fixed-dose combination in HIV therapy, but its long-term growth profile is constrained by (1) aging patient mixes, (2) the shift toward once-daily regimens dominated by newer protease inhibitors (PIs), integrase-based combinations, and non-PI options, and (3) patent and regulatory milestones that enable generic and low-cost competition where exclusivity has lapsed. Financial performance is therefore driven less by new uptake and more by retention of existing patients, payer coverage dynamics, and the pace of channel substitution.

How has EVOTAZ performed financially versus other HIV regimens?

EVOTAZ’s financial trajectory follows the typical pattern of late-lifecycle branded HIV products: revenue peaks early after launch, then declines or plateaus as prescriber preferences shift and competing regimens consolidate market share. The core drivers:

• Therapy mix and prescribing migration: HIV care has moved toward once-daily, integrase-based and non-PI regimens for treatment-naïve and many treatment-experienced patients, shrinking the incremental addressable pool for boosted PI regimens.
• Formulary control and step therapy: Payers increasingly restrict boosted-PI use to narrower clinical scenarios, and they steer toward preferred agents or tiered combinations with better rebates.
• Channel substitution: Even when branded stays on formularies, financial outcomes trend toward lower net pricing as generics and authorized alternatives expand.
• Safety and tolerability trade-offs: EVOTAZ’s boosted atazanavir is associated with known class toxicities (notably hyperbilirubinemia and drug-drug interactions via CYP3A inhibition), which can drive regimen switching.

What competitive landscape pressures does EVOTAZ face today?

EVOTAZ’s competitive set includes both direct PI-based boosted regimens and broader “class-adjacent” alternatives:

• Direct PI competitors (boosted): other atazanavir or boosted PI fixed-dose combinations where available, plus competing PI strategies depending on local formulary preferences.
• Preferred-modern regimens: integrase inhibitor-based single-tablet regimens and other once-daily options that often displace boosted PI use for many patients.
• Economics of PI therapy: PI-based regimens remain clinically relevant but face pressure from payer economics as generics enter the PI components and as newer regimens come to dominate guideline-based prescribing.

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What is the EVOTAZ market size exposure by patient segment and line of therapy?

EVOTAZ’s revenue exposure is concentrated in:

• Treatment-experienced patients maintained on boosted PI regimens when switching risk or resistance patterns favor continuation.
• Patients requiring a PI strategy due to resistance, prior treatment history, or specific clinician decision-making where EVOTAZ remains covered and clinically appropriate.
• Geography-dependent access: market penetration varies by country formulary preferences, reimbursement pressure, and timing of generic availability.

Treatment-naïve vs treatment-experienced: where does EVOTAZ sit?

• Treatment-naïve share: typically constrained by contemporary guideline preference for integrase-based regimens.
• Treatment-experienced share: more resilient because regimen changes require resistance assessment, adherence stability, and tolerability management.

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When does EVOTAZ lose exclusivity and how does that affect sales?

EVOTAZ’s exclusivity and patent landscape governs time windows for generic entry and the durability of branded net pricing. The sales impact is usually highest around:

• Orange Book exclusivity expiration for the listed NDA product, which affects the baseline timing for generic approval pathways.
• Patent expiration across key claim types (composition, formulation, and method-of-use), which determines whether ANDA filers can successfully launch.

What Orange Book status typically drives EVOTAZ generic entry risk?

For legacy HIV combination products, the market dynamic typically depends on:

• Whether core patents list on the Orange Book are still in force
• Whether ANDA applicants file Paragraph IV certifications
• Whether litigation triggers stay periods or results in forfeiture
• Whether generics are able to launch at-risk or after final resolution

Because market impact depends on the specific Orange Book listing set tied to EVOTAZ’s NDA and each patent’s legal status, a precise “date-by-date” exclusivity and expiration timeline requires Orange Book and patent-lifecycle inputs tied to the exact EVOTAZ NDA listing.

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What patents protect EVOTAZ and what claim types matter for generic or biosimilar risk?

EVOTAZ is a small-molecule HIV combination drug. Competitive risk is generic (ANDA) rather than biosimilar. The key protection categories that affect the ability of competitors to launch:

Composition and combination patents

• Claims covering the fixed-dose combination of atazanavir with cobicistat.
• Claims addressing specific salt forms, ratios, or crystalline forms relevant to bioavailability and stability.

Formulation patents

• Film coating, tablet matrix compositions, release profile, and manufacturing-related formulation parameters that can create non-infringing generic designs.
• Process-related claims can also delay ANDA launches even after composition patents expire.

Method-of-use and regimen patents

• Claims tied to therapeutic use such as dosing schedules or patient populations.
• For HIV, method claims are often less determinative than composition and formulation claims, but they can still block launch where successfully asserted.

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How many generics compete with EVOTAZ, and what is the likely launch pattern if patents expire?

For a legacy combination PI booster product, the typical launch pattern after key patents expire is:

1. First ANDA approvals with label parity for the combination strength.
2. Introductory price resets that compress branded net revenue.
3. Secondary competition through additional ANDAs and package-size expansion.
4. Payer renegotiation that reduces branded share, even if branded remains stocked.

The degree of revenue compression depends on how many ANDAs are approved, whether multiple generic manufacturers enter quickly, and whether payer contracting accelerates switching.

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What patent litigation affects EVOTAZ and how do settlements influence timing?

The financial pathway for branded legacy HIV products commonly reflects:

• Paragraph IV disputes that trigger automatic stays while litigation proceeds.
• Settlements that produce delayed generic entry in exchange for payments or other commercial terms.
• Eventual litigation resolutions that enable launch immediately upon remaining patent expiry.

A full legal timeline requires patent-to-case mapping across the specific EVOTAZ NDA and all asserted Orange Book patents.

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What FDA regulatory events shape EVOTAZ trajectory (NDA status, labeling, and approval changes)?

For sales and market dynamics, FDA events matter most through:

• New strength or dosage form approvals that expand addressable demand.
• Label changes that broaden or narrow eligible patients.
• Safety communications that can drive physician switching.
• Generic labeling and bioequivalence requirements that affect time-to-market for ANDA entrants.

A precise EVOTAZ regulatory event timeline requires NDA and label history tied to FDA records for the specific EVOTAZ product.

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How does EVOTAZ pricing and reimbursement typically evolve after generic entry?

Legacy HIV combination products usually experience:

• Net price decline after formulary replacement by generics or authorized equivalents.
• Higher rebating pressure from payer negotiations, especially for drugs moving from preferred to non-preferred tiers.
• Patient retention effects: the branded manufacturer can retain some share through prescriber inertia and clinician comfort, but revenue still compresses due to contracting and cost controls.

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EVOTAZ vs competitor PIs and integrase regimens: how does the market shift change revenue?

EVOTAZ’s competitive positioning is weaker as the regimen market shifts toward integrase-based options for most patients.

What drives share loss for boosted PI fixed-dose combinations?

• Convenience and adherence: once-daily integrase-based regimens often have favorable simplicity.
• Drug-drug interaction burden: boosted PI regimens have higher interaction profiles because of CYP3A inhibition.
• Tolerability and lab monitoring burden: hyperbilirubinemia risk with atazanavir can be a driver of switching.

What keeps EVOTAZ resilient?

• Established patient stability: patients who tolerate EVOTAZ and have durable control may stay on regimen.
• Resistance and prior therapy constraints: clinicians sometimes maintain PI-based therapy when resistance patterns make other options less suitable.
• Regional formulary exceptions: some markets continue to support boosted PI use more broadly.

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Key financial trajectory metrics: what to watch for EVOTAZ revenue

EVOTAZ’s revenue path in the next several years typically hinges on four measurable levers:

1. Share of prescriptions that remain in PI-based maintenance
2. Net price after rebate/contracting changes
3. Speed and number of generic entries
4. Treatment line migration as patients cycle through newer regimens

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Key Takeaways

• EVOTAZ’s financial trajectory is shaped by late-lifecycle branded dynamics: revenue stability depends on patient retention and payer coverage rather than new uptake.
• The primary market pressure is the long-term HIV regimen shift toward integrase-based and non-PI options plus cost-driven formulary controls.
• Generic entry risk is governed by the EVOTAZ Orange Book patent set and any litigation stays or settlements; once key patents expire, net pricing compression and share loss typically accelerate.
• Near-term performance is most sensitive to contracting and the timing of ANDA launches, not to scientific differentiation.

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FAQs

1. What payer and formulary factors most impact EVOTAZ net revenue after generic launches?
2. How do CYP3A-mediated drug-drug interactions influence EVOTAZ persistence on therapy?
3. What clinical scenarios most commonly keep patients on boosted PI regimens like EVOTAZ instead of switching to integrase-based therapy?
4. How does manufacturing scale and distribution readiness affect whether generics can quickly replace EVOTAZ?
5. What is the typical revenue curve for legacy branded HIV combination drugs after first generic ANDA entry?

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References

(No sources cited because no verifiable EVOTAZ-specific Orange Book, patent, FDA, or financial reporting inputs were provided in the prompt.)