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.

There has been one patent litigation case 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 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VOCABRIA
What excipients (inactive ingredients) are in VOCABRIA?	VOCABRIA excipients list
DailyMed Link:	VOCABRIA at DailyMed

Recent Clinical Trials for VOCABRIA

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

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

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

Expired US Patents for VOCABRIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021	10,927,129

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

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
Austria	E516026
Australia	2006239177	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity
Australia	2006307101	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
Brazil	PI0610030	composto, processo para a preparação de um composto, método de tratamento de uma infecção por hiv em um humano, uso de um composto, e, composição farmacêutica
Brazil	PI0617842	composto ou um sal farmaceuticamente aceitável ou um solvato do mesmo, e, composição farmacêutica
Canada	2606282	DERIVE POLYCYCLIQUE DE LA CARBAMOYLPYRIDONE A ACTIVITE INHIBITRICE SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASEINHIBITORY ACTIVITY)
Canada	2626956	DERIVE DE CARBAMOYLPYRIDONE POLYCYCLIQUE AYANT UNE ACTIVITE D'INHIBITION SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE)

Supplementary Protection Certificates for VOCABRIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	C300676	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
1874117	CA 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 20140116
1874117	PA2014021	Lithuania		PRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116
1874117	1490036-9	Sweden		PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
1874117	C20140020 00130	Estonia		PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
1874117	14C0041	France		PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1874117	202 50006-2014	Slovakia		PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121

VOCABRIA Market Dynamics and Financial Trajectory (Rilpivirine ER, Janssen) — Revenue Path, Competitive Pressure, Patent/Generic Risk, and Commercial Outlook

Last updated: July 30, 2026

VOCABRIA (cabotegravir oral tablets) is a branded antiretroviral in the HIV-1 treatment setting that depends on patient conversion into the injectable long-acting regimen. Its financial trajectory is shaped by (1) how quickly patients transition from oral lead-in to CABENUVA (cabotegravir/rilpivirine), (2) payer coverage and prior authorization behavior for oral lead-in, and (3) competition from other long-acting orals and injectables. Competitive dynamics are also driven by dispensing-channel mix and contract rate resets as biosimilar and generic pressure rises across the HIV portfolio.

Because VOCABRIA is an oral lead-in drug for CABENUVA (not the long-acting injectable itself), its revenue can be volatile around injection conversion cycles, clinic adoption curves, and payor formulary status. The most material commercial “step function” is sustained uptake of CABENUVA conversions, not standalone oral persistence.

How is VOCABRIA used commercially, and what drives demand in the HIV market?

Answer: VOCABRIA demand is tied to CABENUVA conversion adoption, oral lead-in completion rates, and payer access rules.

What is the product’s commercial job in the CABENUVA regimen?

VOCABRIA is prescribed as an oral lead-in to establish tolerability before switching to CABENUVA injections (cabotegravir + rilpivirine). Market demand therefore tracks:

• Clinic willingness to adopt a long-acting injectable pathway (workflow readiness, nurse/clinic infusion infrastructure, and patient education)
• Patient persistence through the oral lead-in period
• How frequently prescribers repeat lead-in in cases of missed injection windows or regimen interruptions

What patient segments most affect sales velocity?

Sales velocity tends to concentrate where long-acting injectables are prioritized:

• Patients switching from suppressive oral therapy who value reduced pill burden
• Populations that benefit from adherence support
• Clinics with mature HIV programs that actively manage injection scheduling and retention

Which payer dynamics most affect net sales for an oral lead-in?

Net revenue is heavily influenced by:

• Formulary placement of oral lead-in therapy under plan medical or pharmacy benefit
• Prior authorization length and documentation requirements
• Specialty pharmacy vs buy-and-bill economics for the injection component that can indirectly pull oral lead-in demand
• Contracting intensity and chargeback structure across large accounts

What are the key market dynamics affecting VOCABRIA revenue growth or decline?

Answer: The revenue direction is primarily a function of CABENUVA adoption and injection conversion rates, with secondary drivers from formulary access and segment mix.

Adoption curve and conversion rate effects

VOCABRIA is structurally dependent on CABENUVA conversions. If prescribers expand CABENUVA starts, VOCABRIA typically scales with:

• Higher total initiations
• Improved retention after first injection cycle
• Increased long-term “re-starts” after missed doses that can trigger repeat oral lead-in

If CABENUVA growth slows, VOCABRIA can experience:

• Reduced new starts
• Lower lead-in volumes per patient
• Margin compression as wholesalers and specialty pharmacies negotiate distribution economics

Competitive pressure in long-acting HIV

Commercial pressure often comes from:

• Alternative long-acting oral or injectable antiretroviral regimens that compete for patients eligible for long-acting simplifying therapy
• Formulary rebalancing once competing regimens gain preferred status
• Tendering or network contracting that favors one long-acting platform across a health-system

Even if VOCABRIA is not the direct competitor product, it is exposed as the lead-in “entry point” drug into the CABENUVA pathway.

Operational constraints: injection scheduling and continuity

Because VOCABRIA is a lead-in to injections, injection logistics influence oral demand. When clinics report:

• High missed-injection rates, VOCABRIA lead-in usage can increase due to tolerability re-establishment workflows
• Improved appointment adherence, VOCABRIA usage can stabilize at an initiation-focused pattern

Where does VOCABRIA fit in the HIV treatment competitive landscape, and how does it compare with rival long-acting strategies?

Answer: VOCABRIA is a critical onboarding component into the CABENUVA long-acting injectable regimen; comparisons focus on long-acting pipeline positioning and payer preferences for simplification.

How does VOCABRIA compare with other oral-to-long-acting pathways?

The competitive set is less about “oral HIV tablets vs oral tablets” and more about:

• Competing long-acting injectable platforms (where available)
• Long-acting oral simplification strategies
• Immediate-start strategies that reduce need for extended lead-in

Where competitors reduce initiation complexity (shorter lead-in or alternative initiation protocols), VOCABRIA can face share erosion.

What matters most for win/loss behavior in formularies?

Formulary committees typically evaluate:

• Total regimen cost (oral lead-in plus injection)
• Evidence of adherence benefit and reduced resistance risk from consistent dosing
• Patient-reported outcomes that support continuation
• Real-world persistence after switching

VOCABRIA’s pricing power is tied to the bundled regimen economics.

What is VOCABRIA’s financial trajectory: revenue trend, margin profile, and expectations for net sales?

Answer: VOCABRIA’s financial trajectory tracks CABENUVA adoption and persistence, and net sales are sensitive to formulary coverage and specialty distribution economics.

Revenue sensitivity: oral lead-in volume vs injection starts

Mechanically, VOCABRIA revenue is driven by:

• Number of patients initiated to CABENUVA
• Average lead-in completion rate
• Repeat lead-in events due to missed injections or regimen interruptions

If CABENUVA continues to grow, VOCABRIA can grow in parallel. If CABENUVA saturates within high-adopting centers, VOCABRIA growth can flatten.

Net price and rebate structure

Oral lead-in drugs in specialty HIV are typically exposed to:

• Higher rebate intensity tied to contracted access
• Chargeback and wholesaler margins that shift quickly with channel mix
• PBM re-contracting that can compress net pricing after initial uptake

The primary financial risk for VOCABRIA is not clinical efficacy but access-driven net price compression.

Timing profile

Expect:

• Early growth: clinic adoption and patient onboarding
• Mid-cycle volatility: payer re-negotiation, persistence shifts, and competitor formulary moves
• Later-cycle: stability or decline depending on CABENUVA plateau and competition

What patents protect VOCABRIA and how do they affect long-term revenue risk?

Answer: Patent expiration and follow-on protection determine the magnitude of generic/authorized entrant risk; oral lead-in products are often protected by formulation, method, and use patents that can delay launch.

Patent estate impact on generics

For lead-in oral products, generic risk is constrained by:

• Composition and solid-state/formulation patents
• Method-of-treatment or use patents tied to initiating long-acting injectable regimens
• Orange Book-listed patents and their expiration schedules

A meaningful generic entry typically requires a high-confidence Paragraph IV pathway and the absence of blocking patents.

What is the typical trigger for generic launch planning?

• Patent expiration plus exclusivity windows
• Orange Book “final decision” timing after Paragraph IV litigation
• FDA readiness and ability to manufacture equivalent solid-state forms and meet bioequivalence targets

How many patents cover VOCABRIA, and what is the likely barrier to Paragraph IV challenges?

Answer: The barrier depends on the Orange Book patent list count, remaining life, and litigation posture for any blocking patents.

Key legal constraints that control timing

• Number of unexpired Orange Book patents
• Strength of claims tied to initiation and dosing protocols
• History of settlement or dismissal outcomes in related antiretroviral patent disputes

In long-acting HIV ecosystems, the legal landscape can be more intricate than for standalone tablets because dosing protocols and initiation sequences often anchor use and method claims.

What is VOCABRIA’s Orange Book status and which patent expirations matter for exclusivity?

Answer: Orange Book status determines the expiration schedule relevant to FDA approval and launch timing, including listed patents and any exclusivity protections.

What expirations typically matter for oral HIV lead-in products

• Composition of matter patents: earliest generic vulnerability
• Formulation/solid-state patents: can block alternative manufacturing
• Method-of-use patents: can block “use” carve-ins even if generic chemistry is allowed
• Pediatric exclusivity or other statutory exclusivities: can extend timeline for approval

What generic entry risks exist for VOCABRIA, and when could price pressure start?

Answer: Generic entry risk increases after the last blocking Orange Book patent expires or after a court settlement allows approval. Price pressure generally begins at launch and accelerates as formulary switching follows.

Typical launch mechanics

• FDA approval date is not the same as payer adoption speed
• PBM formularies and contract pricing often lag first generic availability
• Authorized generics (if applicable) can blunt net price discounts

Most likely risk scenario

• A first generic enters post-termination of blocking patents
• Additional entrants follow quickly if manufacturing hurdles are low
• Net price declines depend on how many plans keep preferred branded status

What does VOCABRIA litigation and settlement activity imply about future availability?

Answer: Litigation and settlement outcomes determine whether exclusivity is preserved, shortened, or reshaped by launch carve-outs.

How to interpret patent litigation outcomes commercially

• Settlement terms that permit earlier-than-blocking-patent launch reduce expected branded sales duration
• Dismissals without prejudice can extend uncertainty for generic entrants and delay actual market entry
• Carve-out geographies or indications limit immediate price erosion

What is the FDA regulatory status of VOCABRIA, and how does it influence market access?

Answer: FDA labeling and any line-extension support regimen adoption, with commercial impact coming from coverage criteria built around labeled use.

Regulatory factors affecting prescribing behavior

• Indication clarity on initiation and patient eligibility
• Label requirements that influence prior authorization documentation
• Changes to dosing recommendations that can affect lead-in event frequency

Which companies are most likely to compete against VOCABRIA, and what licensing or switching pathways exist?

Answer: Competitors are primarily generic manufacturers planning for oral lead-in entry, plus branded manufacturers with alternative long-acting or simplification strategies that can displace CABENUVA conversions.

Licensing paths that can accelerate market penetration

If authorized generics or license-based partnerships arise, they can:

• Lower branded net pricing by anchoring a lower acquisition cost
• Reduce branded volume by shifting payer preference

Where does VOCABRIA sit on the value chain, and how does it monetize across channels?

Answer: VOCABRIA monetizes through specialty pharmacy distribution and through clinic-driven conversion workflows that also manage CABENUVA injection scheduling.

Channel mix effects

• Specialty pharmacy tends to dominate oral distribution for complex chronic therapies
• Clinic handling of injections can drive higher coordination costs and can indirectly improve or reduce oral lead-in compliance

Key Takeaways

• VOCABRIA’s financial trajectory is driven mainly by CABENUVA initiation and persistence, not standalone oral use.
• Revenue can be volatile due to payer access, prior authorization rules, and injection scheduling continuity that changes repeat lead-in workflows.
• The primary revenue downside is access-driven net price compression and downstream generic entry after the Orange Book patent estate is fully cleared.
• Patent expiration timing for listed Orange Book patents and any method-of-use blockers is the key determinant of when generics can pressure pricing.
• The competitive battleground is long-acting HIV platform adoption, where any reduction in oral-to-injectable conversion demand can reduce VOCABRIA’s addressable volume.

FAQs

1. How does VOCABRIA oral lead-in demand change when CABENUVA injection starts slow?
2. What payer restrictions most often affect net sales of VOCABRIA for HIV patients?
3. Which Orange Book patent types (composition, formulation, method-of-use) are most likely to delay VOCABRIA generics?
4. How do missed CABENUVA injection events influence repeat VOCABRIA lead-in prescribing?
5. What market signals typically precede a VOCABRIA price decline after generic approval?

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.

DrugChatter Q&A for VOCABRIA

Can Vocabria be used with Rekambys?