Suppliers and packagers for DESCOVY

DESCOVY

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	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215	NDA	Gilead Sciences, Inc.	61958-2002-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2002-1)	2016-04-04
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215	NDA	Gilead Sciences, Inc.	61958-2002-2	30 TABLET in 1 BLISTER PACK (61958-2002-2)	2016-04-04
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215	NDA	Gilead Sciences, Inc.	61958-2005-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2005-1)	2022-01-07

Suppliers and packagers for DESCOVY

Last updated: May 25, 2026

DESCOVY Suppliers: Who Manufactures Descovy (Emtricitabine/Tenofovir Alafenamide) and What Are the Supply Chain IP/Regulatory Barriers?

Executive summary: DESCOVY (emtricitabine 200 mg / tenofovir alafenamide fumarate 25 mg) is marketed by Gilead Sciences and is manufactured for commercial supply by Gilead’s CDMO and drug-substance supply network centered on tenofovir alafenamide (TAF) API and finished-dose production. Key supplier roles typically split across (1) TAF API manufacture, (2) emtricitabine API manufacture, (3) combination tablet finished-dose manufacturing, and (4) packaging and distribution. Under the U.S. FDA framework, the relevant supplier mapping is tied to Orange Book listed manufacturers and FDA facility registrations for the listed dosage form.

Who are the key suppliers and manufacturers for DESCOVY (emtricitabine/tenofovir alafenamide)?

Short answer: The principal “supplier” set for DESCOVY is the Orange Book listed and FDA-registered facilities tied to tablet manufacturing and active ingredient production of emtricitabine and tenofovir alafenamide. The market-facing supplier identity is determined primarily by (a) label/Orange Book “manufactured for” or “listed by” parties and (b) drug-product sites registered to manufacture the NDC strength and dosage form.

Which supply-chain segments exist for DESCOVY

DESCOVY tablets require coordinated supply for:

• Tenofovir alafenamide fumarate (TAF) drug substance (controlled intermediate and final salt form).
• Emtricitabine (FTC) drug substance.
• Tablet drug product: blending, compression, film coating, and release testing.
• Packaging: bottle/box configurations and unit-of-use labeling.
• Distribution: wholesaler and Gilead distribution nodes.

Orange Book-linked supplier mapping: what to extract

For each DESCOVY strength, Orange Book typically supports supplier identification via:

• Orange Book “Applicant/Manufacturer” entries.
• Drug-product manufacturer listing (site-level listing for finished dosage form).
• Medication type (tablet) and application linkage (NDA and supplements).

What does the Orange Book say about DESCOVY suppliers?

Short answer: The most authoritative source for “supplier” identification in the U.S. remains the Orange Book entry for the DESCOVY NDA. The entry lists the applicant and the patent-protected product by dosage form, and it also identifies the listed drug product manufacturer used for FDA regulatory identity.

How Orange Book supplier information is used in licensing and litigation

Supplier names matter because:

• They determine who can be sued or drawn into Paragraph IV or other FDA litigation.
• They influence which parties can support CMC comparability for generics or fixed-dose combinations.
• They affect the practical scope of supply agreements and injunction risk.

Which active ingredient suppliers make tenofovir alafenamide (TAF) for DESCOVY?

Short answer: TAF supply is typically handled by specialized pharmaceutical intermediates and API production networks, with the manufacturer identity determined by FDA facility registrations and the Orange Book-linked manufacturing chain for the NDA.

What to look for in TAF API supplier identification

• FDA drug substance manufacturing site registrations.
• API intermediates (TAF synthesis routes are chemistry-intensive).
• Quality systems and release controls relevant to combination HIV ART products.

Which active ingredient suppliers make emtricitabine (FTC) for DESCOVY?

Short answer: FTC is sourced from drug-substance production networks, with the supplier identity tied to the registered manufacturing site(s) supporting the NDA and the Orange Book-linked drug product.

What drives FTC supplier selection

• API cost and supply reliability for high-volume HIV regimens.
• Compliance history with cGMP and inspection outcomes.
• Ability to support salt/form controls that match finished-dose specifications.

What finished-dose tablet manufacturers supply DESCOVY (emtricitabine/tenofovir alafenamide) in the US?

Short answer: Finished-dose supplier identity is best determined by NDC-specific drug product manufacturing listings and FDA facility registrations for the tablet dosage form.

Common finished-dose manufacturing considerations for combination HIV tablets

• Film coating and uniformity controls across actives.
• Tablet hardness and dissolution targets.
• Stability and packaging compatibility (bottling, desiccant inclusion policies).

How many manufacturing sites supply DESCOVY, and what redundancy exists?

Short answer: The supply redundancy level depends on the number of FDA-registered drug-product sites supporting the NDC and the number of alternative API sources allowed under the application’s CMC package. In practical terms, redundancy can be measured by:

• Number of registered drug substance sites for TAF and FTC.
• Number of registered drug product sites for tablets.
• Support of multiple packaging configurations under the NDA.

What generic or biosimilar entry risks exist for DESCOVY suppliers?

Short answer: Supplier disruption risk concentrates where a generic applicant depends on a non-validated CMC chain or where the branded product’s supplier network is constrained by CMC-protected manufacturing steps and formulation/process patents. For DESCOVY, the primary competitive mechanism is small-molecule generic entry for the combination product, not a biosimilar.

Where supplier constraints show up

• API polymorph or salt form control.
• Tablet manufacture process validation.
• Rapid release/distribution timelines for regimen switching in HIV care.

How does DESCOVY patent estate affect supplier switching or generic supply?

Short answer: Patent protection can restrict manufacturing or marketing of non-infringing alternatives where the generic must use:

• The same combination formulation and/or
• A protected method of manufacture and/or
• A protected use pattern that would trigger FDA legal barriers.

Practical impact on suppliers: even if a new supplier can source the actives, entry can be blocked if the generic cannot use non-infringing formulation/process routes.

What FDA regulatory filings identify DESCOVY manufacturing suppliers?

Short answer: The FDA identifies manufacturing suppliers via:

• Orange Book drug-product and applicant entries for the NDA.
• FDA establishment registration for drug substance and drug product.
• NDA labeling and CMC sections tied to the registered facilities.

How to interpret “manufactured for” language

On U.S. labeling, “manufactured for” can identify:

• The U.S. marketing authorization holder entity, and
• The contract manufacturer relationship for the listed product.

Which countries’ facilities are used to supply DESCOVY tablets and APIs?

Short answer: For U.S. supply, the practical geography is determined by:

• FDA-registered establishment addresses for drug substance and drug product.
• Whether multiple site approvals exist under the NDA for commercial supply.

How does DESCOVY compare with Biktarvy and Truvada on supplier chain complexity?

Short answer: Supplier chain complexity for fixed-dose HIV regimens increases as the actives diversify and as the formulation/process controls tighten. DESCOVY’s comparison with other regimens depends on whether they share:

• TAF supply dependency (shared TAF network if any),
• Similar tablet coating and release controls,
• Similar contract manufacturing platforms for tablets.

Competitive implications for supplier networks

• If brands use consolidated CDMOs for tablets, generics face shared CMC bottlenecks.
• If actives are sourced from a limited number of API sites, alternative-supplier qualification becomes a key timeline risk.

Key Takeaways

• “Suppliers for DESCOVY” in the U.S. are operationally defined by Orange Book and FDA-registered drug-product and drug-substance facilities supporting the NDC tablet combination.
• Supplier identification is used directly in Paragraph IV/generic entry risk, CMC feasibility, and injunction exposure.
• The supply chain breaks into TAF API, FTC API, and tablet finished-dose manufacturing, with packaging as a downstream step.

FAQs

1. How do I identify the exact manufacturing site for DESCOVY tablets (NDC-specific)?
2. Do Orange Book listings show the contract manufacturer for DESCOVY or only the applicant?
3. Which facilities are registered to manufacture tenofovir alafenamide drug substance for DESCOVY in the US?
4. What supply-chain step is most likely to create CMC delays for a DESCOVY generic applicant?
5. Can DESCOVY be supplied through alternate drug-substance sources without an FDA supplement?

References

1. U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. FDA. Drug Establishment Registration and Product Listing (DRLM/registration database).
3. FDA. CDER Drug Manufacturing Facilities and related establishment information.