VEMLIDY Drug Patent Profile

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

Vemlidy 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 VEMLIDY is tenofovir alafenamide fumarate. There are forty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tenofovir alafenamide fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Vemlidy

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

There have been eight 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.

There is one tentative approval for the generic drug (tenofovir alafenamide fumarate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for VEMLIDY

International Patents:	58
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	19
Patent Applications:	1,329
Drug Prices:	Drug price information for VEMLIDY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VEMLIDY
What excipients (inactive ingredients) are in VEMLIDY?	VEMLIDY excipients list
DailyMed Link:	VEMLIDY at DailyMed

See drug prices for VEMLIDY

Recent Clinical Trials for VEMLIDY

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

Sponsor	Phase
Yonsei University	PHASE4
National Taiwan University Hospital	Phase 2
PharmaEssentia	Phase 2

See all VEMLIDY clinical trials

Pharmacology for VEMLIDY

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

Paragraph IV (Patent) Challenges for VEMLIDY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VEMLIDY	Tablets	tenofovir alafenamide fumarate	25 mg	208464	6	2019-11-05

US Patents and Regulatory Information for VEMLIDY

VEMLIDY is protected by two US patents and one FDA Regulatory Exclusivity.

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	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes	9,296,769*PED				Y
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes	8,754,065*PED				Y
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes

Expired US Patents for VEMLIDY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	7,803,788

International Patents for VEMLIDY

When does loss-of-exclusivity occur for VEMLIDY?

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 VEMLIDY around the world.

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	1466	Prodrugs of phosphonate nucleotide analogues and methods for selecting and making same.
Australia	2001282941
Australia	2005225039

Supplementary Protection Certificates for VEMLIDY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C01419152/02	Switzerland		PRODUCT NAME: RILPIVIRIN UND TENOFOVIR; REGISTRATION NO/DATE: SWISSMEDIC 62155 12.03.2013
1419152	PA2012009,C1419152	Lithuania		PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128

Vemlidy (tenofovir alafenamide) Market Dynamics and Financial Trajectory: Pricing, Competition, Exclusivity, and Revenue Exposure (Gilead)

Last updated: July 21, 2026

Vemlidy (tenofovir alafenamide, TAF) is Gilead’s flagship chronic hepatitis B (CHB) product, with volume anchored by long-term oral adherence and a competitive landscape defined by other nucleotide analogs (TDF, entecavir) and CHB treatment penetration dynamics in key markets. Financial trajectory is primarily driven by (1) U.S. and EU share versus competitors, (2) persistence for lifelong or multi-decade treatment, and (3) pricing and contracting pressure in managed markets as generic tenofovir and alternative strategies expand.

How has Vemlidy performed financially and what revenue drivers dominate now?

Fast answer: Vemlidy’s revenue path is governed by durability of CHB therapy, mix shift by geography and patient type, and pricing pressure offset by continued share gains and new-country launches. The key watch items are annual prescriptions in treatment-naïve versus switch populations and net pricing after rebates.

Revenue model drivers for chronic hepatitis B

Vemlidy competes in a category where prescriber behavior and guideline adherence support repeat prescribing:

• Long treatment horizon: CHB management often requires continuous therapy, supporting sustained demand.
• Switch dynamics: Patients moving from older nucleos(t)ides (notably TDF) or from other regimens are a major share lever.
• Safety and tolerability: TAF’s renal and bone safety profile influences switching and preferred prescribing in patients with comorbidities.

Primary financial levers companies track

• Net sales and gross-to-net compression: Contracting and rebate intensity in the U.S. and major EU markets.
• Geographic mix: U.S., Japan, and Europe are typically higher-margin; emerging markets follow launch and reimbursement cycles.
• Formulary positioning: Hospital and specialist access in high-volume CHB centers.

Competitive pricing pressure channels

• Generic substitution in adjacent therapies: Although Vemlidy itself is not a simple generic target early in most geographies, competition from lower-cost regimens (e.g., entecavir and generic TDF in many markets) shifts payer and prescriber cost sensitivity.
• Outcome-based contracting: Where payers evaluate safety and adherence proxies, cost offsets can favor TAF but do not eliminate pricing pressure.

What market dynamics affect Vemlidy share in chronic hepatitis B?

Fast answer: Vemlidy’s share is driven by patient selection and guideline alignment for patients needing long-term therapy, especially those where renal or bone safety matters, and by the ability to maintain persistence among switched and newly treated patients.

Patient-segmentation dynamics

• Treatment-naïve patients: Prescribers use guideline recommendations, viral response rates, and long-term safety to select first-line therapy.
• Switch patients from TDF: TAF adoption is influenced by monitoring findings (eGFR decline, bone density concerns) and clinician preference.
• Adherent persistence: CHB therapies depend on daily dosing; persistence is a major determinant of revenue stability.

Geographic demand profile

• U.S. and EU: Specialty prescribing, formulary and contracting impact growth rate.
• Japan and other developed markets: Uptake depends on reimbursement and clinician trust in long-term data.
• Emerging markets: Growth is constrained by willingness-to-pay and generic availability of older agents.

Which competitors pressure Vemlidy and how does competition typically play out?

Fast answer: Competition is anchored by older nucleos(t)ide analogs and by cost-sensitive payer choices. Vemlidy’s differentiation is clinical tolerability, while generic lower-cost options cap pricing power.

Core comparator set

• Tenofovir disoproxil fumarate (TDF): Still widely used and often available as generics in many markets.
• Entecavir: Cost-effective and entrenched; still a common alternative for nucleoside-first strategies.
• Other CHB options: Pegylated interferon historically served specific patient profiles; modern practice is dominated by nucleos(t)ide analog selection.

How competition impacts financial trajectory

• Share stability vs price erosion: Vemlidy tends to sustain volume better than its pricing, but net price can compress under managed care.
• Switching as a margin lever: Switching from TDF can preserve Vemlidy volume even when treatment-naïve growth slows.
• Payer behavior: When payers tighten criteria for “preferred” branded therapies, net sales can underperform despite stable prescribing.

When does Vemlidy lose exclusivity and what does that mean for financial risk?

Fast answer: Financial risk from exclusivity loss depends on U.S. patent expiration timing, Orange Book listing status for tenofovir alafenamide products, and whether generic applicants can launch immediately or after patent workarounds. For CHB, generic entry risk can be partially muted if treatment patterns favor switch-to-TAF, but sustained brand pricing typically erodes after generic availability.

Patent and regulatory framework that governs launch timing

• Orange Book listings: Exclusivity exposure is managed through patent listing granularity (drug substance, formulation, and method-of-use).
• Paragraph IV pathway risk: Generic timing can compress if challengers prevail on key claims or win settlements that allow earlier launch.
• Pediatric exclusivity and data exclusivity: Can extend market protection even if some patents expire, depending on jurisdiction and product category.

What is the Orange Book status of Vemlidy and which patent listings matter most?

Fast answer: The practical question for investors and litigators is not “does Vemlidy have patents,” but “which Orange Book patents are listed for Vemlidy and are still enforceable against a generic filing.” That determines whether a generic can launch on an at-risk basis.

What to monitor in Orange Book mechanics

• Drug substance vs drug product patents: Product/formulation patents can remain a barrier even if substance patents narrow.
• Method-of-use claims: Can delay generic entry if generics cannot “design around” indication-level claims.
• Expiration-by-patent and geographic enforceability: Litigation and administrative events can reorder the practical risk timeline.

(Note: This section requires a product-specific Orange Book extract to enumerate the exact patent numbers, listed expiration dates, and dispute status. Without that listing content, a precise patent-by-patent Orange Book status table cannot be produced.)

How many patents protect Vemlidy and what is the likely strength by claim type?

Fast answer: In most branded small-molecule antivirals, patent estates include layered protection around compound, formulations, and dosing regimens. For Vemlidy, the strength assessment needs claim-by-claim enforcement history and the remaining term for each Orange Book listed patent.

Claim-type risk mapping (what drives generic challenge outcomes)

• Compound claims (tenofovir alafenamide): If any remain enforceable, they are the highest barrier to generic entry.
• Formulation claims (TAF drug product): Often targeted by generics for design-around potential.
• Method-of-use claims: If enforceable, they can block label-appropriate launches.
• Manufacturing process claims: Sometimes create a technical hurdle even when the compound is available.

(Note: A defensible “how many patents” count with specific numbers and expiration dates requires an Orange Book and assignment/litigation record export for Vemlidy.)

What patent litigation and Paragraph IV challenges affect Vemlidy?

Fast answer: Generic launch timing for Vemlidy depends on whether any challengers filed Paragraph IV certifications, whether they asserted invalidity or non-infringement against Orange Book patents, and whether settlements created delayed entry or license structures.

What litigation outcomes typically change

• Settlement-triggered launch dates: Parties sometimes agree on entry at a future date or restrict label scope.
• Injunction leverage: If courts maintain certain patents, the practical launch timeline shifts.
• Claim narrowing: Even if a court invalidates some claims, remaining claims can still delay.

(Note: A specific litigation docket summary with case numbers, settlements, and dates requires direct case data.)

What biosimilar risk applies to Vemlidy?

Fast answer: No biosimilar risk applies. Vemlidy is a small-molecule antiviral, not a biologic.

How does Vemlidy compare with competing CHB therapies on commercial economics?

Fast answer: Vemlidy’s commercial advantage is patient safety profile and clinician preference for long-term therapy; its commercial vulnerability is that entrenched generics (notably generic TDF and entecavir) set a low-cost benchmark that constrains net pricing.

Economic comparison by payer perspective

• Payer short-term costs: Lower acquisition cost options can win formulary placement when budgets tighten.
• Payer long-term cost offsets: If renal/bone monitoring and downstream event reduction are reflected in contracting, Vemlidy can retain premium positioning.
• Patient adherence: Better tolerability can translate into fewer discontinuations, improving persistence-adjusted LTV.

What generic entry scenarios are most plausible for Vemlidy and when could they occur?

Fast answer: Generic entry scenarios are typically (1) full generic launch after patent expiry, (2) delayed launch after settlement, or (3) partial launch with label limitations if method-of-use patents remain enforceable.

Scenario framework used by market strategists

• Scenario A: earliest lawful launch
  • Triggered by expiration of the last blocking Orange Book patent(s) and any relevant regulatory exclusivity.
• Scenario B: settlement-mediated delayed launch
  • Triggered when challengers settle for a later entry date.
• Scenario C: at-risk launch
  • Occurs if generics enter while litigation remains and lose or win in ways that affect ultimate market access.

(Note: Accurate “when” requires patent-by-patent Orange Book term dates and litigation outcomes.)

How do manufacturing and IP barriers shape Vemlidy’s competitive threat?

Fast answer: The competitive threat is controlled more by IP and label barriers than by manufacturing complexity because Vemlidy is a small-molecule oral product. However, formulation and process details can still create hurdles for generic sponsors, especially if formulation claims are still active.

Where manufacturing intersects with IP

• Formulation know-how: If formulation patents exist, generic manufacturers may need to demonstrate non-infringement or design-around.
• Stability and bioavailability: Generic development must maintain bioequivalence, and any formulation-specific constraints can slow entry.

Key takeaways

• Vemlidy’s financial trajectory is driven by persistence in chronic hepatitis B therapy and clinician switching from older nucleos(t)ides, with net pricing under pressure from low-cost generic comparators.
• The dominant timing risk is patent and regulatory protection of the TAF product as reflected in Orange Book listings and any Paragraph IV litigation or settlements.
• No biosimilar risk applies because Vemlidy is a small molecule.
• For decision-making, the actionable monitoring list is: Orange Book listed patents and dates, any Paragraph IV filings and outcomes, and U.S./EU net pricing and formulary placement trends tied to managed care contracting.

FAQs

1. What net sales metrics best predict Vemlidy revenue durability in CHB?
   Prescription growth, persistence rates, and net pricing (gross-to-net) by geography and managed-care tier.

2. Can generic TDF or entecavir erode Vemlidy without direct generic substitution?
   Yes. They cap payer willingness-to-pay and influence first-line and switch decisions, affecting share and net price.

3. What determines whether a Vemlidy generic can launch with the same CHB label?
   Enforceable method-of-use and other Orange Book patents tied to indication-specific claims.

4. How do settlements typically change Vemlidy’s competitive launch timeline?
   They can set a future launch date, restrict label scope, or include licensing terms that delay market entry.

5. What therapeutic response outcomes matter most for maintaining Vemlidy share?
   Viral suppression and safety outcomes that support guideline adherence and clinician confidence for long-term therapy.

References

(No sources were cited because the prompt does not include Vemlidy-specific financial statements, Orange Book patent listing data, litigation dockets, or payer/market reports required to provide factually specific, patent-number-level and timeline-level content.)

DrugChatter Q&A for VEMLIDY

When soes the patwnt on vemlidy run out?
When vemlidy patent expires?
Vemlidy loss of exclusivity?
Average monthly cost vemlidy for hepatitis b?
Does medicare cover vemlidy?