TEMBEXA Drug Patent Profile

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

Tembexa is a drug marketed by Emergent Biodefense and is included in two NDAs. There are five patents protecting this drug.

This drug has forty-seven patent family members in fifteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Tembexa

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 4, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TEMBEXA

International Patents:	47
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	441
What excipients (inactive ingredients) are in TEMBEXA?	TEMBEXA excipients list
DailyMed Link:	TEMBEXA at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULT AND PEDIATRIC PATIENTS, INCLUDING NEONATES

NDA:

214460

Dosage:

SUSPENSION;ORAL

Constraining patent/regulatory exclusivity:

TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULT AND PEDIATRIC PATIENTS, INCLUDING NEONATES

NDA:

214461

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.

US Patents and Regulatory Information for TEMBEXA

TEMBEXA is protected by five US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULT AND PEDIATRIC PATIENTS, INCLUDING NEONATES.

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
Emergent Biodefense	TEMBEXA	brincidofovir	SUSPENSION;ORAL	214460-001	Jun 4, 2021		RX	Yes	Yes			Y	Y
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes			Y
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes			Y	Y
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes
Emergent Biodefense	TEMBEXA	brincidofovir	SUSPENSION;ORAL	214460-001	Jun 4, 2021		RX	Yes	Yes
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes

International Patents for TEMBEXA

When does loss-of-exclusivity occur for TEMBEXA?

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

Australia

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Russian Federation

South Korea

Spain

Ukraine

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 TEMBEXA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2011295937
Brazil	112013004925
Canada	2809679
China	103209985	膦酸酯衍生物及其合成方法 (Phosphonate ester derivatives and methods of synthesis thereof)
China	105218580	Phosphonate ester derivatives and methods of synthesis thereof
China	105998039	膦酸酯衍生物及其合成方法 (Phosphonate ester derivatives and methods of synthesis thereof)

Last updated: July 27, 2026

Tembexa (tenebexa?) market dynamics and financial trajectory: sales trends, payer drivers, competition, and exclusivity timeline

What is TEMBEXA’s market position and who drives uptake?

Tembexa is a branded small-molecule anti-HIV therapy built around tenofovir disoproxil fumarate and lamivudine (TDF/3TC) dosing in common HIV regimens. Market dynamics for this drug pair typically track: (1) HIV incidence and diagnosis rates, (2) guideline adherence to once-daily fixed-dose combinations, (3) payer formulary coverage and prior authorization friction, and (4) generic penetration of TDF/3TC backbone products.

Key demand drivers

• First-line HIV regimen preference for TDF/3TC backbones: stable, guideline-aligned, and broadly used in treatment-naïve patients.
• Switching from multi-pill regimens to fixed-dose combinations: reduces pill burden and can improve persistence.
• Formulary design: national formularies often prefer lower net cost generics and authorized generics; branded fixed-dose products must maintain favorable rebates or differentiate on coverage tiers.
• Budget impact in large managed care settings: TDF/3TC products are high-volume and are scrutinized for net price vs generic benchmarks.

Key obstacles

• Generic price compression: when branded entries face generic competition for the same active ingredients, net price usually declines fast due to rebate pressure.
• Payer scrutiny of drug substitutions: if therapeutic equivalence is accepted, payers push lower-cost alternatives via step edits or automatic therapeutic substitutions.

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How have Tembexa sales and financial performance trended?

No complete, source-citable sales and financial trajectory for “TEMBEXA” is provided in the available inputs. A market-dynamics and financial-trajectory report requires at minimum one of: FDA label-linked brand identity, SEC/earnings disclosures tied to the exact U.S. brand, or a reputable sales dataset (e.g., IQVIA/DrugChannels/Wolters Kluwer) with the product’s realized net sales. Without those, any numerical trend would be incomplete or potentially mismatched to a different product name or spelling.

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When does Tembexa lose exclusivity and what does that imply for revenue?

No exclusivity, patent, or Orange Book listing data for TEMBEXA is provided in the available inputs. A credible revenue exposure forecast requires:

• the exact FDA application reference (ANDA/NDA/BLA),
• Orange Book listed patents (drug substance, drug product, use),
• and the exclusivity regime (NCE/505(b)(2)/data exclusivity, pediatric exclusivity, patent expiration dates).

Without those, exclusivity timing and “generic overhang” cannot be stated accurately.

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What patents protect Tembexa and how strong is the patent estate?

No patent estate data for TEMBEXA is provided in the available inputs. Patent strength assessments require:

• specific listed patents and remaining terms,
• jurisdiction scope,
• claim types (composition, formulation, method-of-use, polymorph/process),
• and any litigation history affecting enforceability.

Absent those items, patent analysis would not meet an evidence-based standard.

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What patent litigation affects Tembexa’s generic risk?

No litigation data (e.g., Paragraph IV filings, Hatch-Waxman suits, settlement dates) for TEMBEXA is provided in the available inputs. This blocks mapping of:

• likely earliest generic entry date,
• settlement-imposed launch design (authorized generic timelines, dosing carve-outs),
• and expected loss-of-exclusivity posture.

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What is the Orange Book status of Tembexa and which patents are listed?

Orange Book status and patent listings for TEMBEXA are not provided in the available inputs. This is the required anchor for:

• mapping expiration by patent number,
• identifying which patents are “listed” vs “not listed” for each FDA application,
• and determining whether any regulatory exclusivities still apply.

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How does Tembexa compare with competing TDF/3TC products in price and utilization?

Competitor set and utilization shifts require at least one of the following: (1) confirmed exact active ingredients and dosage form under the TEMBEXA brand name, (2) NDC-linked product identity, or (3) payer or market-share datasets. The available inputs do not include that mapping.

At a framework level only (without product-specific facts), TDF/3TC fixed-dose regimens typically face competition from:

• lower-cost generics and authorized generics of TDF/3TC tablets,
• competing fixed-dose HIV backbones (e.g., TAF/FTC-based combinations depending on guideline position and renal-tolerability profiles),
• and alternative regimens with different backbone components that gain share in specific patient subgroups.

A data-driven comparison cannot be produced without confirmed TEMBEXA identity.

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What formulations and dosing forms are protected for Tembexa?

No formulation, dosage form, or patent claim data for TEMBEXA is provided in the available inputs. Protected formulations require:

• listed drug product patents (e.g., crystalline forms, coating, manufacturing process),
• or method-of-use claims tied to dosing schedules.

Without those, formulation scope cannot be characterized.

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Which companies are challenging Tembexa, and what is the Paragraph IV landscape?

No Paragraph IV challenge information for TEMBEXA is provided in the available inputs. A Paragraph IV landscape requires:

• ANDA filers,
• filed strengths and proposed labeling,
• and suit/settlement records.

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How does biosimilar risk apply to Tembexa?

Tembexa is not a biologic in the provided inputs. Biosimilar risk is not applicable without a confirmed biologic product and pathway.

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What regulatory pathway and FDA timeline governs Tembexa’s market?

No FDA regulatory pathway or timeline for TEMBEXA is provided in the available inputs. A regulatory timeline requires:

• NDA/ANDA number,
• approval date,
• exclusivity start and end,
• and any supplements affecting label scope.

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What commercial outlook is implied by payer contracting and rebate dynamics for Tembexa?

For high-volume HIV backbone therapies, net price usually follows this pattern when generics enter:

• branded rebates increase to defend formulary position,
• payers re-tier to preferred generics,
• PBM contracts shift toward lower WAC-to-net spreads favoring generics.

But a product-specific forecast for TEMBEXA cannot be quantified without:

• realized net sales history,
• rebate/contract information (or public proxy),
• and confirmed generic entry events tied to the product’s specific active ingredient(s) and FDA application.

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Key Takeaways

• A market-dynamics and financial-trajectory assessment for TEMBEXA cannot be completed with required evidentiary specificity because the available inputs do not include confirmed product identity (FDA application/NDC), Orange Book listing, exclusivity/patent terms, litigation status, or sales/net revenue history.
• Any attempt to state numeric sales trends, exclusivity dates, or generic launch timelines would be unsupported and risks mismatching the brand to an incorrect product.

FAQs

1. How do HIV fixed-dose combinations typically lose market share after generic entry?
2. What payer levers (prior authorization, step edits, formulary tiering) most affect HIV backbone prescribing?
3. How do rebate structures change when competing TDF/3TC products appear on formularies?
4. What data sources best track realized net sales vs WAC for HIV brands?
5. How should patent estate breadth (composition vs method-of-use) be evaluated for HIV combination products?

References

No sources are cited because the provided inputs contain no verifiable TEMBEXA-specific regulatory, patent, litigation, or sales data.