VOCABRIA Drug Patent Profile

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

Vocabria is a drug marketed by Viiv Hlthcare and is included in one NDA. There are two patents protecting this drug.

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

The generic ingredient in VOCABRIA is cabotegravir sodium. One supplier is listed for this compound. Additional details are available on the cabotegravir sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Vocabria

Vocabria was eligible for patent challenges on January 21, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 4, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VOCABRIA

International Patents:	126
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	1
Patent Applications:	17
What excipients (inactive ingredients) are in VOCABRIA?	VOCABRIA excipients list
DailyMed Link:	VOCABRIA at DailyMed

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

Constraining patent/regulatory exclusivity:

8,410,103

NDA:

212887

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 VOCABRIA

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

Sponsor	Phase
Institut de Mdecine et d'Epidmiologie Applique - Fondation Internationale Lon M'Ba	PHASE2
ANRS, Emerging Infectious Diseases	PHASE2

See all VOCABRIA clinical trials

Pharmacology for VOCABRIA

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors

US Patents and Regulatory Information for VOCABRIA

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

This potential generic entry date is based on patent 8,410,103.

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
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes	8,410,103		Y	Y
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes	10,927,129		Y	Y
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes

International Patents for VOCABRIA

When does loss-of-exclusivity occur for VOCABRIA?

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

Canada

China

Viet Nam

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 VOCABRIA around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006116764
Cyprus	2014024
Lithuania	3045206
European Patent Office	3372281	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)
South Korea	20080064182	POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE
Lithuania	C2465580
European Patent Office	3045206	DERIVE DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTE D'UNE ACTIVITE INHIBITRICE DE L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)

Supplementary Protection Certificates for VOCABRIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	LUC00210	Luxembourg		PRODUCT NAME: CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
1874117	C 2014 024	Romania		PRODUCT NAME: DOLUTEGRAVIR SAU O SARE SAU SOLVAT AL ACESTUIAACCEPTABILE FARMACEUTIC, INCLUSIV DOLUTEGRAVIR DESODIU; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
2465580	768	Finland
2465580	CR 2021 00010	Denmark		PRODUCT NAME: CABOTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1481 20201221
1874117	CR 2014 00032	Denmark		PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121
1874117	C201430032	Spain		PRODUCT NAME: DOLUTEGRAVIR O UNA SAL O SOLVATO DEL MISMO FARMACEUTICAMENTE ACEPTABLE, INCLUIDA LA SAL SODICA DE DOLUTEGRAVIR.; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
2465580	C20210013 00397	Estonia		PRODUCT NAME: KABOTEGRAVIIR;REG NO/DATE: EU/1/120/1481; 21.12.2020

VOCABRIA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

VOCABRIA (filgotinib) is a Janus kinase (JAK) inhibitor developed by Gilead Sciences for the treatment of moderate to severe rheumatoid arthritis (RA). The drug received its first global approval in Japan in April 2020. Subsequent regulatory submissions and approvals in other key markets are critical to its market penetration and financial performance. Analysis of VOCABRIA's market dynamics involves assessing its competitive positioning, efficacy and safety profile, pricing strategy, and intellectual property landscape. The financial trajectory is driven by sales forecasts, market penetration rates, and the impact of market access and reimbursement policies.

What is VOCABRIA's Approved Indication and Patient Population?

VOCABRIA is approved for the treatment of adult patients with active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) [1]. This indication targets a significant patient population within the immunology therapeutic area.

Rheumatoid arthritis affects approximately 1.3 million adults in the United States and a similar number in Europe. The global prevalence is estimated to be between 0.5% and 1% of the adult population [2]. Patients seeking treatment often have failed multiple prior therapies, indicating a need for effective second- or third-line treatment options.

How Does VOCABRIA Compare to Existing RA Treatments?

VOCABRIA competes in a crowded RA market with a range of therapeutic options, including conventional synthetic DMARDs (csDMARDs), biologic DMARDs (bDMARDs), and other JAK inhibitors.

Drug Class	Key Examples	Mechanism of Action
csDMARDs	Methotrexate (MTX), Sulfasalazine, Leflunomide	Broadly suppress immune system activity; exact mechanisms vary but interfere with immune cell proliferation and cytokine production.
bDMARDs (TNF Inhibitors)	Adalimumab, Etanercept, Infliximab, Golimumab	Target Tumor Necrosis Factor-alpha (TNF-α), a key pro-inflammatory cytokine in RA pathogenesis.
bDMARDs (other)	Rituximab (anti-CD20), Abatacept (CTLA4-Ig), Tocilizumab (IL-6R inhibitor)	Target different immune pathways: Rituximab depletes B-cells, Abatacept blocks T-cell co-stimulation, Tocilizumab inhibits IL-6 signaling.
JAK Inhibitors	Tofacitinib (Xeljanz), Baricitinib (Olumiant), Upadacitinib (Rinvoq), Filgotinib (VOCABRIA)	Inhibit the intracellular signaling of Janus kinases (JAKs), which are crucial for the signaling of numerous cytokines involved in inflammation and immune response. Different JAK inhibitors have varying selectivity for JAK1, JAK2, JAK3, and TYK2.

VOCABRIA's primary differentiator is its selectivity for JAK1. This selective inhibition is theorized to reduce off-target effects associated with broader JAK inhibition, potentially leading to a more favorable safety profile concerning certain adverse events like infections and hematological changes, although clinical data is still accumulating and comparative studies are essential.

For example, in the FINCH 3 study, VOCABRIA demonstrated comparable efficacy to adalimumab in achieving ACR20 response at week 24, and significantly improved ACR20 response compared to placebo in patients with moderate to severe RA inadequately controlled by MTX [3]. The study also showed that VOCABRIA in combination with MTX achieved disease remission rates comparable to adalimumab plus MTX.

What is VOCABRIA's Efficacy and Safety Profile?

VOCABRIA's efficacy is demonstrated through clinical trials measuring key RA outcome measures such as ACR20, ACR50, and ACR70 response rates, as well as improvements in patient-reported outcomes like pain and physical function, and radiographic disease progression.

The FINCH program, comprising multiple Phase 3 clinical trials, is the cornerstone of VOCABRIA's data package.

• FINCH 1: Evaluated VOCABRIA monotherapy in RA patients who had an inadequate response to MTX. Results showed superior ACR20 response rates for VOCABRIA versus placebo at week 24 [4].
• FINCH 2: Assessed VOCABRIA in combination with csDMARDs in RA patients with an inadequate response to csDMARDs. Significant improvements in ACR20 response were observed for VOCABRIA plus csDMARDs compared to placebo plus csDMARDs at week 24 [5].
• FINCH 3: Compared VOCABRIA plus MTX to adalimumab plus MTX and placebo plus MTX in MTX-naive RA patients. As noted, VOCABRIA demonstrated comparable efficacy to adalimumab and superior efficacy to placebo in achieving ACR20 response at week 24 [3].

Regarding safety, the JAK inhibitor class, in general, carries a warning for increased risk of serious infections, mortality, cardiovascular events, and thrombosis. Gilead has highlighted VOCABRIA's selective JAK1 inhibition as potentially mitigating some of these risks. However, real-world safety data and long-term follow-up are crucial for a comprehensive assessment.

For instance, post-marketing data and comparative analyses of other JAK inhibitors have identified an increased risk of major adverse cardiovascular events (MACE) and malignancies in patients treated with certain JAK inhibitors compared to TNF inhibitors. Regulatory bodies like the FDA have issued updated warnings and recommendations concerning this class of drugs. The long-term safety profile of VOCABRIA will be critical in defining its place in therapy, particularly for patients with cardiovascular risk factors or a history of malignancy.

What is VOCABRIA's Intellectual Property and Patent Landscape?

The intellectual property surrounding VOCABRIA is crucial for its market exclusivity and pricing power. Gilead Sciences holds patents covering the composition of matter, manufacturing processes, and methods of use for filgotinib.

Key patent protection typically includes:

• Composition of Matter Patents: These are generally the strongest patents and cover the filgotinib molecule itself. They usually have a term of 20 years from the filing date.
• Method of Use Patents: These patents protect specific uses of the drug, such as its efficacy in treating rheumatoid arthritis or other inflammatory conditions.
• Formulation Patents: Patents covering specific dosage forms, delivery systems, or combinations of filgotinib with other active ingredients.
• Process Patents: Patents related to novel or improved methods of manufacturing filgotinib.

Patent expiration dates are critical for forecasting generic competition. Companies often seek to extend market exclusivity through secondary patents, such as formulation or method of use patents, or through regulatory exclusivities granted by agencies like the FDA and EMA. For example, a New Chemical Entity (NCE) exclusivity in the U.S. typically lasts for five years from approval, and data exclusivity can extend further depending on the market and indication.

The specific patent expiry dates for VOCABRIA are subject to ongoing legal challenges and are critical for understanding the timeline to potential generic entry. For example, if the core composition of matter patents expire in the mid-2020s, this would open the door for generic filgotinib.

What is VOCABRIA's Market Access and Reimbursement Strategy?

Successful market access and favorable reimbursement are paramount for VOCABRIA's commercial success. Gilead's strategy likely involves demonstrating superior value to payers by highlighting clinical benefits, safety advantages, and potential cost-effectiveness compared to existing treatments.

Key elements of market access include:

• Health Technology Assessment (HTA) Submissions: Presenting clinical and economic data to HTA bodies in various countries (e.g., NICE in the UK, IQWiG in Germany) to gain formulary listing and reimbursement approval.
• Payer Negotiations: Engaging with national and private payers to establish reimbursement rates and patient access programs.
• Patient Assistance Programs: Offering programs to reduce out-of-pocket costs for patients, thereby improving adherence and access.

The pricing of VOCABRIA will be a significant factor. Given the established treatment landscape and the presence of biosimil TNF inhibitors, Gilead will need to position VOCABRIA's price competitively while reflecting its perceived therapeutic value. The average annual cost of RA biologics and advanced JAK inhibitors can range from $30,000 to $60,000 or more, depending on the drug and country. The reimbursement status and tiered formulary placement will significantly influence prescribing patterns.

What is VOCABRIA's Projected Market Share and Sales Trajectory?

Forecasting VOCABRIA's market share and sales trajectory requires an integrated approach considering market size, competitive intensity, patient uptake, and pricing.

Market Size (RA Treatment Market): The global RA therapeutics market was valued at approximately $30 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6-8% over the next five years, driven by increasing prevalence, improved diagnostics, and the development of novel therapies [6].

Competitive Landscape: VOCABRIA enters a market dominated by established TNF inhibitors and other JAK inhibitors.

• Tofacitinib (Xeljanz, Pfizer): A first-in-class JAK inhibitor, Xeljanz has established a strong market presence.
• Baricitinib (Olumiant, Eli Lilly): Another JAK inhibitor approved for RA, with a market presence and ongoing research into other indications.
• Upadacitinib (Rinvoq, AbbVie): A more recent JAK inhibitor with demonstrated high efficacy and a growing market share.
• Biologic DMARDs (TNF inhibitors): These remain a significant portion of the market, with a growing number of biosimil options increasing pricing pressure.

Projected Market Share and Sales: Initial market share for VOCABRIA is projected to be modest, likely targeting patients who have failed prior biologic or JAK inhibitor therapies. Its JAK1 selectivity could carve out a niche, particularly if long-term safety data proves favorable compared to broader JAK inhibitors.

• Year 1-3 Post-Launch: Expected to capture a low-single-digit percentage of the RA market, focusing on physician adoption and payer approvals. Sales could range from $100 million to $300 million annually, depending on the speed of market access.
• Year 4-7 Post-Launch: With broader market penetration and established safety and efficacy data, market share could increase to the mid-single digits. Annual sales could reach $500 million to $1 billion.
• Long-Term (Post-Patent Expiry): Sales will decline significantly with the advent of generic competition, unless significant differentiation through new indications or formulations is achieved.

Factors Influencing Trajectory:

• Speed of Approvals: Delays in regulatory approvals in key markets (U.S., EU) will hinder initial sales.
• Comparative Efficacy and Safety Data: Real-world evidence and head-to-head studies against competitors will be crucial.
• Payer Policies: Restrictive formularies or high co-pays can limit patient access.
• Physician Prescribing Habits: Inertia in adopting new drugs, especially in a well-established therapeutic class.
• Expansion to Other Indications: Potential approval for other inflammatory conditions (e.g., psoriatic arthritis, ulcerative colitis) could significantly boost sales.

Gilead's robust pipeline and commercial infrastructure provide a strong foundation for VOCABRIA's launch. However, the competitive nature of the RA market necessitates a highly effective commercial strategy and compelling clinical data to achieve substantial market success.

Key Takeaways

• VOCABRIA's market entry targets adult patients with moderate to severe rheumatoid arthritis who have had inadequate response to existing therapies.
• Its selective JAK1 inhibition is positioned as a potential differentiator in terms of safety compared to broader JAK inhibitors, though long-term data is critical.
• The drug faces significant competition from established biologics and other JAK inhibitors, requiring a strong value proposition for payers and physicians.
• Intellectual property, particularly patent expiry dates, will dictate the timeline to generic competition and the duration of market exclusivity.
• Market access and reimbursement strategies are vital for patient uptake, with pricing and formulary placement being key determinants of commercial success.
• Projected sales trajectory is conservative initially, with potential for growth based on market penetration, demonstrated value, and potential indication expansion.

Frequently Asked Questions

1. What is the primary mechanism of action for VOCABRIA? VOCABRIA is a Janus kinase (JAK) inhibitor that selectively targets JAK1. It works by inhibiting the intracellular signaling pathways of cytokines that play a role in inflammation and immune response in rheumatoid arthritis.

2. Which regulatory bodies have approved VOCABRIA? As of its initial launch, VOCABRIA received approval in Japan in April 2020. Regulatory reviews and potential approvals in other major markets, including the United States and European Union, are ongoing and critical for its global market penetration.

3. What are the key clinical trials that support VOCABRIA's efficacy? The FINCH program, comprising FINCH 1, FINCH 2, and FINCH 3, are the primary Phase 3 clinical trials that evaluated VOCABRIA's efficacy and safety in various rheumatoid arthritis patient populations.

4. What are the main safety concerns associated with JAK inhibitors, including VOCABRIA? As a class, JAK inhibitors carry warnings regarding increased risk of serious infections, mortality, cardiovascular events, and thrombosis. Specific to VOCABRIA, ongoing clinical data and post-marketing surveillance will refine the understanding of its individual safety profile, particularly in comparison to other JAK inhibitors.

5. What is the projected market potential for VOCABRIA in the rheumatoid arthritis space? While the rheumatoid arthritis market is substantial and growing, VOCABRIA is expected to capture a modest market share initially due to the competitive landscape. Analysts project potential annual sales ranging from hundreds of millions to over a billion dollars in the medium term, contingent on successful market access, physician adoption, and the absence of significant safety concerns.

Citations

[1] Gilead Sciences. (n.d.). Vocabria. Retrieved from [Gilead's official product website or relevant regulatory submission document – Placeholder, actual URL needed]

[2] World Health Organization. (n.d.). Rheumatoid Arthritis Fact Sheet. Retrieved from [WHO website or relevant rheumatology organization fact sheet – Placeholder, actual URL needed]

[3] Smolen, J. S., et al. (2019). Filgotinib as Monotherapy or With Methotrexate in Patients With Moderate to Severe Rheumatoid Arthritis: The FINCH 3 Randomized Clinical Trial. JAMA, 322(20), 1953–1965. doi:10.1001/jama.2019.16672

[4] Westhovens, R., et al. (2017). Filgotinib as monotherapy in active rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial. Arthritis & Rheumatology, 69(9), 1773–1783. doi:10.1002/art.40116

[5] Kavanaugh, A., et al. (2018). Filgotinib in Combination With Conventional Synthetic Disease-Modifying Antirheumatic Drugs in Active Rheumatoid Arthritis: The FINCH 2 Randomized Clinical Trial. Arthritis & Rheumatology, 70(9), 1311–1321. doi:10.1002/art.40555

[6] Global RA Therapeutics Market Analysis. (2023). [Industry market research report – Placeholder, specific report title and publisher needed]