Suppliers and packagers for genvoya

genvoya

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561	NDA	Gilead Sciences, Inc.	61958-1901-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-1901-1)	2015-11-05

GENVOYA Suppliers: Key API, Fill-Finish, and Packager Vendors Across Manufacturing and Distribution

Last updated: May 24, 2026

GENVOYA (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) supply is concentrated around Gilead Sciences’ vertically integrated development and manufacturing network, with contract manufacturing and logistics executed by third parties. Public procurement and facility data do not support a complete, itemized list of every upstream supplier of API and excipients by name in the U.S. label scope. What can be stated cleanly from public regulatory and manufacturer-facing records is the identity of the primary listed NDA manufacturer(s) and typical roles in the supply chain that you can map to specific facilities for due diligence.

What companies supply GENVOYA API, finished dosage, and contract manufacturing?

Answer: The primary “supplier” for GENVOYA in FDA-facing records is the NDA holder and its labeled manufacturer network under Gilead Sciences. Upstream API and intermediate sourcing is executed through Gilead’s qualified supply chain, with third-party fill-finish and distribution roles in the broader supply chain.

Who is listed as the GENVOYA manufacturer on FDA-facing materials?

In the U.S., GENVOYA is marketed under Gilead Sciences, Inc., with labeled manufacturing activity tied to Gilead’s network of drug substance and drug product sites. Contract suppliers typically appear at the level of facility rather than brand-specific “company supplier” naming.

What types of suppliers sit behind GENVOYA?

GENVOYA supply generally breaks into these vendor categories:

• Drug substance (API) suppliers for four actives: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide.
• Excipients and film-coating / tablets components (including polymer systems used for coated tablets).
• Drug product (tableting, coating, packaging) via fill-finish or toll-manufacturing at qualified plants.
• Secondary packaging (bottles, cartons, desiccants, lot serialization where applicable).
• Primary distribution and wholesaler logistics (common distribution networks used by branded and generic supply chains).

What patents protect GENVOYA and how do they affect supplier qualification?

Answer: Patent coverage for GENVOYA affects entry timelines, API qualification, and contract manufacturing onboarding by constraining alternative sourcing and by requiring licensing for non-infringing manufacturing pathways if any are outside patent scope.

What is the IP “gate” for alternative sourcing and contract manufacturing?

For a combination product like GENVOYA, the practical supplier gating factors are:

• Drug substance process and composition-of-matter coverage for each active.
• Fixed-dose combination formulation patents covering the final blend and tablet design.
• Method-of-use patents covering therapeutic regimens, if any.
• Regulatory exclusivity and patent listing in the FDA Orange Book for the NDA.

What is the Orange Book status of GENVOYA?

GENVOYA’s Orange Book listings can include multiple patents across actives and formulations. That listing determines whether a prospective API supplier can lawfully market non-infringing intermediates for the NDA’s reference product or whether they must operate through licensed rights or different patent regimes.

When does GENVOYA lose exclusivity and what does that mean for supplier diversification?

Answer: Exclusivity and listed patent expirations determine whether additional qualified suppliers become practical for brand-to-generic transition and for authorized generic strategies.

How do patent expirations drive procurement changes?

As listed patents approach expiry, buyers typically expect:

• Additional qualified API manufacturers to be onboarded for regulatory and supply continuity.
• New CMO fill-finish capacity to reduce lead-time risk.
• More tender competition among excipient and packaging vendors due to broader market access and price normalization.

Which manufacturers are supplying GENVOYA globally (dosage form and packaging variants)?

Answer: Global distribution uses Gilead-controlled packaging and distribution channels, with local labeling, warehousing, and sometimes local packaging under region-specific agreements. Public web-visible supplier identities rarely map cleanly to brand-specific “supplier of record.”

What dosage form is supplied and how does it shape supplier requirements?

GENVOYA is supplied as an oral tablet. That implies supplier requirements for:

• Tablet compression and coating equipment.
• Controlled moisture handling for hygroscopic components.
• Stability-validated packaging systems.

What packaging formats affect vendor lists?

Packaging formats typically include:

• Bottle presentations with desiccant.
• Carton labeling tied to region codes and lot/batch traceability.

What generic entry risks exist for GENVOYA suppliers?

Answer: Generic entry risks do not directly change upstream supplier lists unless the generic maker requires a specific API supply chain or claims generic equivalents under NDA/BLA pathways. In practice, risks show up as:

• Delays in supplier qualification due to patent litigation or “carve-outs.”
• Licensing barriers for API process know-how.
• Batch rejection risk if regulators or contract labs find bioequivalence issues.

How do Paragraph IV challenges affect supplier qualification?

Paragraph IV filings by generic manufacturers can trigger:

• Injunction risk that limits purchase orders.
• Settlement-driven licensing that may require specific sourcing or manufacturing methods.
• Qualification freezes at certain CMOs.

How strong is the patent estate for GENVOYA and how does that impact supply chain leverage?

Answer: Combination ART products like GENVOYA usually have layered patent estates across each active and the fixed-dose tablet formulation. That layering raises the transaction friction for alternative sourcing, because CMOs need assurance that their processes remain within licensed rights or design-around scope.

What suppliers can do under layered IP?

Suppliers can generally proceed in three ways:

• Operate within Gilead-qualified channels and licensing terms.
• Use alternative processes that avoid infringement, then qualify with Gilead or regulators.
• Provide to downstream contract manufacturers only if they hold or secure necessary IP rights.

What FDA manufacturing and regulatory considerations constrain GENVOYA suppliers?

Answer: For a combination product, constraints are mostly cGMP capability and the ability to supply consistently to NDA specifications, including dissolution, impurity profiles, and stability. Regulatory constraints also affect whether CMO changes trigger supplemental filings.

What manufacturing steps drive CMO selection?

Typical selection criteria for GENVOYA tablet production and packaging include:

• cGMP track record for combination HIV products.
• Ability to manage multi-active granulation and coating.
• Validated analytical methods for impurities and residual solvents.
• Data integrity and batch traceability for pharmacovigilance and recalls.

What does the GENVOYA supplier landscape look like versus other Gilead HIV combinations?

Answer: Supply chain structure for GENVOYA resembles other Gilead fixed-dose HIV combinations in that it is built on a mix of Gilead-labeled manufacturing and qualified third-party capacity for drug product and logistics. Differences show up in the number of actives and their API sourcing complexity.

Quick comparative lens: why supplier lists diverge across fixed-dose combinations

• More complex multi-active supply chains increase the number of qualified upstream API vendors.
• Changes in salt forms or particle engineering (notably for tenofovir alafenamide) increase supplier-specific capability requirements.
• Tablet coating and stability constraints narrow packaging vendor eligibility.

Key Takeaways

• GENVOYA supply is led by Gilead’s NDA and labeled manufacturing network; upstream “supplier of record” for each API is not reliably published as a complete brand-specific vendor roster.
• Practical supplier identification for due diligence must be facility-based: drug substance and drug product cGMP sites that appear in regulatory filings and label manufacturer listings.
• Patent and exclusivity constraints govern supplier onboarding and alternative sourcing timing by increasing IP and qualification friction.
• As exclusivity wanes, expect increased CMO capacity availability and API onboarding, but only after patent and regulatory pathways clear.

FAQs

1) What contract manufacturing organizations typically produce fixed-dose HIV tablets like GENVOYA?
CMOs with cGMP capacity for multi-active tablet compression and coating, with validated dissolution and impurity controls for combination ART products.

2) Do excipient and bottle/secondary packaging vendors get listed for GENVOYA in FDA filings?
They are usually not listed by name at the brand level; facility and supplier qualification is handled through NDA/CMC systems and controlled change documentation.

3) How do formulation patents affect alternative API sourcing for GENVOYA?
They limit certain manufacturing pathways or require licenses if an alternative supplier’s process or final blend design falls within patented formulation or method claims.

4) What are the biggest operational bottlenecks in GENVOYA supply?
API availability for all four actives, tablet coating/stability constraints, and synchronized batch release through packaging and distribution.

5) How does the risk of recall or batch failure influence supplier choice for GENVOYA?
Buyers favor suppliers with robust analytical method capability, historical batch acceptance rates, and traceability systems to reduce batch rejection and recall scope.

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. Drug Development and Approval Processes: Labeling and manufacturing information resources. https://www.fda.gov/drugs/development-approval-processes-drugs
3. Gilead Sciences, Inc. GENVOYA prescribing information and label resources (access via FDA labeling repository and company label postings). https://www.accessdata.fda.gov/