ODEFSEY Drug Patent Profile

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

Odefsey is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-eight patent family members in forty-two countries.

The generic ingredient in ODEFSEY is emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Odefsey

Odefsey was eligible for patent challenges on November 5, 2019.

There have been nineteen 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 ODEFSEY

International Patents:	58
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	175
Drug Prices:	Drug price information for ODEFSEY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ODEFSEY
What excipients (inactive ingredients) are in ODEFSEY?	ODEFSEY excipients list
DailyMed Link:	ODEFSEY at DailyMed

See drug prices for ODEFSEY

Pharmacology for ODEFSEY

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Paragraph IV (Patent) Challenges for ODEFSEY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ODEFSEY	Tablets	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	200 mg/25 mg/ 25 mg	208351	3	2019-11-05

US Patents and Regulatory Information for ODEFSEY

ODEFSEY is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	AB	RX	Yes	Yes	8,754,065*PED				Y
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	AB	RX	Yes	Yes	9,296,769*PED				Y

Expired US Patents for ODEFSEY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	8,101,629
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	6,838,464
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	7,125,879
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	8,080,551
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	7,803,788
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	7,067,522

International Patents for ODEFSEY

When does loss-of-exclusivity occur for ODEFSEY?

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

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Mexico

Moldova, Republic of

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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 ODEFSEY around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	170750
Austria	219366
Austria	270291
Austria	361293
Austria	469147
Australia	1367692

Supplementary Protection Certificates for ODEFSEY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	C300529	Netherlands		PRODUCT NAME: RILPIVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT, IN HET BIJZONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
1419152	C300532	Netherlands		PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE EN ELKE DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN,; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1419152	PA2012008	Lithuania		PRODUCT NAME: RILPIVIRINUM; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
1419152	PA2012009	Lithuania		PRODUCT NAME: EMTRICITABINUM + RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
1419152	CA 2012 00021	Denmark
1419152	CA 2012 00019	Denmark

ODefsey market dynamics and financial trajectory (HIV cART, Gilead) ODefsey (emtricitabine/rilpivirine/tenofovir alafenamide) is a late-line branded HIV combination in a maturing market shifting toward long-acting injectables, two-drug regimens, and generics of older backbones. Sales have moved from post-launch growth to a downtrend as payers rationalize formularies and clinicians switch patients to competitors, including long-acting cabotegravir/rilpivirine and newer once-daily single-tablet regimens. Financial trajectory and forward risk are driven by: (1) patent/generic pressure on multi-NRTI combinations, (2) competitive displacement in treatment-naïve and suppressed patients, and (3) payer controls tied to lowest net cost.

What is the commercial trajectory of Odefsey (emtricitabine rilpivirine tenofovir alafenamide) and why do sales change?

ODefsey’s revenue path is primarily explained by HIV regimen mix changes, pricing dynamics, and patient switching behavior.

HIV prescribing mix shifts

Key drivers affecting Odefsey:

• Formularies move toward “preferred” regimens with stronger net-cost positions or lower administrative burden.
• Clinical preference trends toward regimens with fewer switching triggers, especially around lipid and renal safety narratives that can favor alternative tenofovir prodrugs or integrase-based backbones depending on patient profile.
• Long-acting therapy uptake increases churn away from daily oral regimens in eligible populations.

Payer and net pricing

In mature antiretroviral markets, gross sales often understate economics because rebate structures and pharmacy benefit manager incentives compress net revenue. Odefsey’s exposure comes from:

• Competitive class clustering around once-daily single-tablet regimens.
• Periodic payer “tiering” that pushes therapy to lower-cost SKUs as generics and biosimilars pressure brand economics across therapy areas.

How do market dynamics for Odefsey compare with Gilead’s other HIV single-tablet regimens?

ODefsey is a competitor within Gilead’s broader HIV portfolio and against class rivals from ViiV Healthcare, Janssen, and others.

Position versus Gilead’s flagship HIV brands

• Gilead’s principal HIV revenue drivers sit in other backbone and INSTI-containing regimens that often face less displacement risk because of clinician preference and payer placement.
• Odefsey’s rilpivirine-based regimen competes against more frequently favored INSTI backbones for many switch and first-line decisions. In practice, this can create lower “default share” in newly initiating patients unless specific patient factors favor rilpivirine.

Position versus integrase-based single tablets

The major competitive axis is integrase-based once-daily regimens, which generally have:

• Strong efficacy profiles across patient subgroups
• Broader uptake for switching from older regimens
• Less reliance on dietary timing requirements tied to rilpivirine

Where does Odefsey face the highest competitive pressure: treatment-naïve starts or switch patients?

ODefsey’s share pressure tends to concentrate in switching and formulary-driven moves.

Treatment-naïve starts

For treatment-naïve patients, competitive intensity is determined by:

• Clinician and guideline alignment around INSTI-first strategies
• Payer criteria limiting non-INSTI options unless specific suitability criteria are met

Switch and maintenance

For suppressed patients on daily oral therapy, switching triggers are influenced by:

• Long-acting eligibility and payer support for injections
• Side-effect profiles and tolerability preferences
• Net cost and formulary placement, which can shift stable patients even when clinical alternatives are equivalent

When does patent and exclusivity risk affect Odefsey generics and how does it impact sales forecasting?

Generic risk is typically not a single date event. It arrives as a sequence:

• Orange Book-listed patent expirations and secondary patent cliffs
• Potential Paragraph IV filings followed by negotiated settlements or litigated entry timing
• Labeling expansion and clinician adoption after bioequivalence approvals

ODefsey’s commercial risk profile depends on the cadence of Orange Book expirations and any Paragraph IV challenges to listed patents tied to the product. That risk shapes forecasting by creating stepwise loss of share when a low-cost entrant gains access to the market.

What is the Orange Book status of Odefsey and how many patents protect it?

Orange Book status is the gatekeeper for estimating entry timing and litigation probability. For a branded combination drug like Odefsey, protection usually covers:

• Composition-of-matter for the active ingredients or combination
• Formulation patents for the tablet composition
• Method-of-use patents tied to specific dosing or patient populations
• Manufacturing process patents

The number and type of Orange Book patents listed for Odefsey, along with their expiration dates, determine the “effective brand life” against generic entry risk and drive the shape of expected sales declines.

Last updated: July 20, 2026

Has Odefsey faced Paragraph IV challenges and what do those cases imply for launch timing?

Paragraph IV challenges are the direct signal for near-term generic revenue exposure because they indicate at least one generic company believes it can challenge a listed patent and enter at risk or via settlement.

To forecast Odefsey sales under generic pressure, the key variables are:

• Whether there are active Paragraph IV cases
• Whether settlements exist and their terms (entry date, marketing start)
• Whether “at-risk” launches were permitted and when they occurred

What generic entry risks exist for Odefsey by dosage form and formulation?

For single-tablet regimens, formulation and manufacturing control points matter:

• Brand tablets can have formulation-specific patents that delay full generic substitution.
• Manufacturing process patents can limit “drop-in” copies even after composition challenges.

Generic substitution timing impacts sales trajectory via:

• First generic launch (partial reimbursement and limited switching)
• Second wave of entrants (pricing pressure and broader formulary acceptance)
• Pharmacy benefit normalization that accelerates patient switching

How does Odefsey compare with long-acting HIV therapies for market share and patient retention?

Long-acting cabotegravir/rilpivirine introduces a retention tradeoff:

• It reduces adherence burden for eligible patients
• It triggers payer behavior because a covered long-acting injection can replace a daily oral regimen

ODefsey’s rilpivirine component can create a psychological and practical bridge for some patients, but the deciding factor is whether providers and payers direct patients toward long-acting regimens.

What is the financial impact of HIV volume changes and pricing pressure on Odefsey’s trajectory?

ODefsey’s revenue exposure is sensitive to:

• Volume: number of patients on therapy within payer covered populations
• Price: net price after rebates and discounts
• Mix: oral maintenance versus switch to long-acting or integrase-based alternatives
• Geography: intensity of generic adoption and tendering practices

In mature markets, pricing pressure often dominates incremental volume changes because clinicians frequently select among equivalent clinical options based on net cost and formulary rules.

How many patients can Odefsey reach and how does patient selection constrain sales?

ODefsey’s addressable population is constrained by regimen suitability and clinical preferences:

• Rilpivirine-based regimens can face limitations driven by baseline viral load and drug-drug interaction concerns in real-world use.
• Patient switching is influenced by tolerability and by how clinicians prioritize integrase-based regimens.

These constraints mean that even when overall HIV treated populations remain stable or grow slowly, Odefsey’s share can still decline due to selection effects.

What regulatory and label factors affect Odefsey market dynamics?

Regulatory label scope influences switching patterns, including:

• Eligibility for treatment-naïve versus switch/suppressed populations
• Any safety warnings that drive prescriber caution
• Any postmarketing updates affecting drug interactions

Label conservatism can slow adoption in switching cohorts if competing labels are broader for the same patient segment.

Which companies compete most directly with Odefsey and what are their likely moves?

Main competitive groups:

• Integrase-based single-tablet regimen makers (ViiV Healthcare, Janssen, others)
• Long-acting injection manufacturers (ViiV Healthcare’s cabotegravir/rilpivirine is the primary commercial comparator in many markets)
• Generic entrants targeting oral combination SKUs as Orange Book barriers fall

Commercially, competitors typically respond through:

• Formulary contracting and rebates
• Increased use of switch pathways to move stable patients
• Launch sequencing to capture post-exclusivity demand

Key timeline: how to read Odefsey financial trajectory against exclusivity and competition

Below is the decision framework used by market participants to map financial trajectory to competitive milestones. Dates must align with Orange Book listings and FDA regulatory events.

Milestone type	What it does to Odefsey sales	How it shows up in the financial trajectory
Orange Book primary/secondary patent expirations	Increases probability of generic entry	Starts a longer sales plateau then accelerates decline
Paragraph IV filings	Signals likely court outcome and entry timeline	Market prices in future volume loss
Generic launch (first entrant)	Initiates payer switching and lower ASPs	Discrete drop in share and pricing
Additional entrants	Amplifies price erosion and formulary normalization	Steeper sales decline in subsequent quarters
Long-acting penetration	Sustained oral displacement	Gradual share loss, slower recovery after price actions

Key Takeaways

• Odefsey’s financial trajectory is shaped by regimen displacement inside a maturing HIV market, with the strongest threat from integrase-based single-tablet regimens and long-acting injectables.
• Generic entry risk is the dominant “cliff” variable, determined by Orange Book patent and litigation cadence. Paragraph IV challenges and settlements control the timing and magnitude of brand share loss.
• Net price compression driven by payer rebates and formulary tiering is likely as important as volume changes for forecasting Odefsey revenue.
• Forward outlook is a function of (1) remaining effective patent life and (2) whether prescriber behavior continues to favor daily oral INSTI strategies over rilpivirine-based alternatives.

FAQs

1. What is the main competitive threat to Odefsey versus other HIV single-tablet regimens?
2. How does long-acting cabotegravir/rilpivirine adoption change oral regimen market share for Odefsey?
3. What Orange Book and litigation milestones most influence Odefsey generic launch timing?
4. How do payer formulary and rebate mechanics typically affect net sales for HIV combination brands like Odefsey?
5. What formulation-specific or method-of-use patent categories are most likely to delay generic competition for a single-tablet HIV regimen?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA: Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
3. Gilead Sciences. Investor relations: quarterly and annual results (Odefsey-related HIV portfolio reporting). https://investors.gilead.com/
4. Patents and litigation dockets: generic entry and Paragraph IV case databases (FDA 30-day notices and court filings via public sources).

DrugChatter Q&A for ODEFSEY

Apotex generic for odefsey?
Odefsey patent expiration?
Is there a shortage for odefsey?
When does odefsey exit its patent?
Is there a generic for Odefsey?