TAGRISSO Drug Patent Profile

Which patents cover Tagrisso, and what generic alternatives are available?

Tagrisso is a drug marketed by Astrazeneca and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-three patent family members in forty-four countries.

The generic ingredient in TAGRISSO is osimertinib mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the osimertinib mesylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Tagrisso

Tagrisso was eligible for patent challenges on November 13, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 25, 2032. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases 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.

There is one tentative approval for the generic drug (osimertinib mesylate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for TAGRISSO

International Patents:	193
US Patents:	5
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAGRISSO

Paragraph IV (Patent) Challenges for TAGRISSO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TAGRISSO	Tablets	osimertinib mesylate	40 mg and 80 mg	208065	3	2019-11-13

US Patents and Regulatory Information for TAGRISSO

TAGRISSO is protected by seventeen US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,524,951.

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
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No	9,732,058		Y	Y
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-002	Nov 13, 2015		RX	Yes	Yes
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No

International Patents for TAGRISSO

When does loss-of-exclusivity occur for TAGRISSO?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Nicaragua

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

Uruguay

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 TAGRISSO around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	098989
Australia	2015204218
Canada	2933403
Chile	2016001609

Supplementary Protection Certificates for TAGRISSO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1848414	CA 2016 00033	Denmark		PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204
1848414	122016000056	Germany		PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160202
1848414	93160	Luxembourg		PRODUCT NAME: OSIMERTINIB (TAGRISSO); FIRST REGISTRATION DATE: 20160204
1848414	132016000078445	Italy		PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 20160204

TAGRISSO (osimertinib) Investment Scenario and Patent/Competition Fundamentals Analysis (Exclusivity, Orange Book, Generic Risk, and Supply-Licensing Outlook)

Last updated: July 29, 2026

TAGRISSO is a branded oral EGFR TKI led by AstraZeneca (AZ) for EGFR-mutated NSCLC. The investment case is driven by: (1) durability of patent and regulatory exclusivity in the U.S.; (2) competitive pressure from earlier-line EGFR TKIs and combination regimens; (3) ongoing probability-weighted risk from generic or biosimilar-like substitutes only via generic entry pathways that remain constrained by formulation, use, and manufacturing patent estates; and (4) upside from continued label expansion (including adjuvant and broader resistance settings). Core risks are revenue erosion from next-generation sequencing-driven prescribing shifts, payer constraints, and any successful patent attack that enables early Paragraph IV launches.

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What patents protect TAGRISSO (osimertinib) in the U.S.?

Core answer: TAGRISSO’s U.S. protection is a layered estate across composition-of-matter, crystalline/formulation variants, and method-of-use claims tied to specific clinical settings in EGFR-mutated NSCLC. The practical outcome is that generic entry timing is governed less by a single “main” patent and more by whether generic challengers can circumvent multiple claim sets listed on FDA’s Orange Book and unlisted patents asserted through litigation.

Key patent estate components investors track

1. Active-ingredient protection

   • Composition-of-matter coverage on osimertinib and closely related chemical structures.
   • Rights typically extend into later years depending on priority/filing dates and patent-term adjustments and extensions.

2. Formulation and solid-state protection

   • Crystalline form, polymorph, hydrate/solvate, particle size or morphic stability.
   • Drug product manufacturing controls and tablet/capsule-specific specs that can block “design-around” generics.

3. Method-of-use / treatment-setting protection

   • Claims tied to EGFR mutation subsets (exon 19 deletion, L858R, T790M).
   • Claims anchored to line of therapy and clinical setting: metastatic first-line, T790M-positive disease, and later expansions like adjuvant approaches in resected disease.
   • These claims often force a generic to file for narrower indications or wait for multiple carve-outs to expire.

How to translate the patent estate into an investment risk score

• High security if multiple Orange Book-listed patents cover the relevant drug product and key method-of-use patents are still active.
• Medium risk if only a subset of patents are still enforceable, or if asserted patents have high likelihood of invalidation based on prior art.
• Low risk for investors only if litigation history shows no credible challengers with viable non-infringement/invalidity positions and if settlement patterns reflect early, non-escalating entry barriers.

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When does TAGRISSO lose exclusivity in the U.S.?

Core answer: Exclusivity timing is governed by two overlapping schedules: (1) statutory regulatory exclusivity (data and marketing exclusivity tied to FDA approval pathways) and (2) patent expiration plus any patent-term adjustments or extensions. The “earliest generic date” relevant for investment is not the last marketing exclusivity date by itself. It is the first date a generic can enter without infringing Orange Book-listed patents for the specific ANDA label it seeks.

Investment-relevant timeline framework

• Step 1: Regulatory exclusivity
  • Determines when an ANDA can be filed under Hatch-Waxman without being blocked by exclusivity. This is an FDA approval pathway gating factor.
• Step 2: Orange Book patent clocks
  • Determines when a Paragraph IV challenger can launch at risk or when it becomes “safe” for an FDA approval.
• Step 3: Litigation and settlement
  • A Paragraph IV dispute can shift entry through negotiated settlements or court outcomes.
• Step 4: “Practical” launch timing
  • Includes manufacturing readiness, label carve-outs, and payer contracting realities after FDA approval.

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What Orange Book status does TAGRISSO have, and which patents are listed?

Core answer: TAGRISSO is listed in the FDA Orange Book with multiple patents covering the drug substance and drug product plus methods of use. The economic impact is that investors must map each listed patent to its expected coverage of generic entry for specific indications.

Orange Book mapping investors should model

• Drug substance patents: often control the earliest entry date if they remain valid and enforceable.
• Drug product patents: control if generics can’t use alternative formulation/process specs while remaining bioequivalent.
• Method-of-use patents: control indication-specific entry and can force a generic to launch only on narrower labels, limiting substitution speed.

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Which Paragraph IV challenges are filed for TAGRISSO, and what do they imply for generic entry risk?

Core answer: Generic entry risk is driven by whether generic applicants filed ANDAs referencing TAGRISSO and included Paragraph IV certifications (notice of invalidity or non-infringement). Each Paragraph IV event becomes a probabilistic catalyst: a win for the generic can accelerate launch, while settlements or adverse judgments tend to push launch later.

How investors should interpret the risk mechanics

• If Paragraph IV certifications target only a subset of patents: risk is more contained; generics may still be blocked for core indications.
• If certifications attack key composition-of-matter or primary formulation patents: risk rises because the bottleneck patents become invalidated or found not infringed.
• If litigation settlements include early entry dates with shared revenue or delayed launch triggers: entry can be earlier than “pure expiration math.”

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How strong is the TAGRISSO patent estate for blocking generics?

Core answer: The estate strength is measured by density of enforceable, Orange Book-listed protections tied to both the drug product and clinical use claims, plus a litigation environment that typically disincentivizes “quick” at-risk launches.

Strength indicators investors can quantify

1. Number of active Orange Book patents
2. **Breadth across:
   • composition-of-matter
   • formulation
   • methods-of-use by EGFR mutation and line/setting**
3. Litigation track record
   • likelihood of sustained injunctions or entry delays
4. Design-around resistance
   • whether alternative crystalline forms or formulation routes still fall within claim scope

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What formulations are protected for TAGRISSO, and what manufacturing/IP barriers exist?

Core answer: TAGRISSO’s relevant barriers for generic development include solid-state and formulation patents that can cover specific crystalline forms, particle size distribution, stability attributes, and manufacturing controls. These patents can prevent bioequivalent products from being produced without crossing claim boundaries.

Practical barriers

• Crystalline form or polymorph restrictions that are hard to “route around” without demonstrating non-infringement.
• Process parameters that drive particle properties.
• Formulation dissolution and stability controls that connect to method-of-manufacture claims.

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How does TAGRISSO’s exclusivity and patent life compare with competing EGFR TKIs?

Core answer: Compared with earlier-generation EGFR TKIs, TAGRISSO benefits from a later-dated patent estate and multi-layer protections, but it still faces higher therapeutic substitution pressure as combination regimens and newer sequencing strategies expand.

Competitive comparison dimensions that matter for investment

• Line of therapy positioning
  • First-line versus later-line durability.
• Resistance mutation coverage
  • Whether competitor molecules cover the resistance landscape similarly.
• Formulation convenience
  • Oral once-daily regimens often compress substitution friction.
• Payer formulary position
  • Commercial uptake depends on net pricing and prior authorization practices.

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What companies are challenging TAGRISSO, and what do their ANDA strategies signal?

Core answer: Generic challengers typically signal strategy through:

• which patents they certify under Paragraph IV,
• which indications they seek at launch,
• and whether they file for full or partial label coverage.

Strategy patterns investors should map

• Indication carve-outs
  • Launch only for indications that are less protected.
• Patent attack selection
  • Focusing on formulation vs. composition-of-matter.
• Settlement probability
  • Repeat challengers with prior settlement outcomes often indicate lower probability of protracted trial outcomes.

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What patent litigation affects TAGRISSO, and how do court outcomes shift entry timing?

Core answer: Patent litigation impacts entry timing through:

• injunctions affecting FDA approval timing,
• court findings that narrow claim scope,
• and settlement agreements that specify an agreed launch date.

How to model litigation outcomes for an investment case

• Probability-weighted dates
  • one date under “patent upheld” scenario
  • one date under “invalidated or non-infringed” scenario
• Settlement as a base case
  • In practice, many high-stakes oncology patent disputes settle; the base case often becomes a negotiated early entry date rather than the “true expiration.”

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What settlement agreements exist for TAGRISSO, and when do they permit launch?

Core answer: Settlement terms typically define a mutually agreed launch window, often including:

• a date-specific entry permission,
• shared or royalty-based compensation structures,
• and sometimes additional non-infringement conditions.

Investment impact: settlements convert legal uncertainty into calendar certainty, which improves valuation models. Investors should treat settlements as the controlling event for “earliest safe market entry,” not only patent expiration math.

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What is the FDA regulatory status of TAGRISSO, and what pathways constrain competition?

Core answer: TAGRISSO is approved by FDA for EGFR-mutated NSCLC across multiple treatment settings and has had label updates over time. The ability of generics to enter is constrained by ANDA requirements for bioequivalence and patent certifications and, if applicable, exclusivity periods tied to the original approvals and key label expansions.

Regulatory elements investors factor into demand durability

• Label scope
  • Broader approved uses expand eligible patient populations.
• On-label adoption
  • Physicians often prioritize label-aligned regimens in oncology, improving continuity of prescribing.
• Safety and tolerability
  • Real-world persistence affects revenue retention.

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What generic entry risks exist for TAGRISSO, and what launch scenarios are most plausible?

Core answer: Generic entry risk is not a single binary event. It is an indication-by-indication sequence governed by which patents are defeated or remain enforceable.

Launch scenario matrix for investment underwriting

1. Full-label launch scenario
   • Requires clearance or expiration of composition-of-matter and key method-of-use patents covering all relevant indications.
2. Partial-label launch scenario
   • Generic enters only for less-protected indications; substitution in the most revenue-dense setting may not occur immediately.
3. At-risk launch scenario (if permitted)
   • If a generic is launched during litigation, risk transfers to the generic; AZ may seek enforcement through court actions. Delays or injunctions can occur.

Revenue exposure logic

• Estimate revenue exposure as:
  • total TAGRISSO revenue × proportion of sales in the indications protected by the patents still at risk
  • subtract expected competitive penetration after a given launch year
• If method-of-use patents remain active, penetration in those settings can remain slow even after a generic is approved for other indications.

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How does TAGRISSO compare with alternative EGFR therapies in switching risk and time-to-erosion?

Core answer: Switching risk depends on which competitors can match clinical efficacy in first-line and resistance-adjacent settings and whether payers enforce biomarker-driven pathways that favor specific agents.

Underwriting variables

• Sequencing guidelines and trial consensus
  • If clinical practice standardizes a competitor earlier, TAGRISSO new patient starts can decline even without immediate generic competition.
• Real-world persistence
  • If tolerability remains strong, TAGRISSO maintains incumbent retention.
• Net price erosion
  • Even without generics, parallel competitive pricing pressure can reduce net revenue.

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What is the supply and manufacturing readiness risk for generic entrants to TAGRISSO?

Core answer: Manufacturing readiness is often a hidden constraint. Even if patent barriers are cleared or bypassed, generics must demonstrate bioequivalence with the correct formulation behavior, and production must be scalable.

Manufacturing factors that delay or limit competition

• solid-state properties that control dissolution profiles
• stability and scale-up yields
• batch consistency for bioequivalence demonstrations

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Investment fundamentals for TAGRISSO: what drives valuation in the next 3–5 years

Core answer: The near-to-mid-term valuation hinges on: (1) maintaining protected market exclusivity in the core indication mix; (2) sustaining new patient starts and line-of-therapy positioning; (3) managing competitive pressure from other EGFR TKI strategies; and (4) the probability-adjusted date for any Orange Book-clearing event.

What to include in a probability-weighted DCF / scenario model

• Base case: continued branded share with gradual payer pressure; no successful broad patent knockouts.
• Bull case: delayed generic launch dates due to upheld patents or unfavorable Paragraph IV outcomes; label expansion supports volume.
• Bear case: settlement or adverse decision accelerates generic entry in high-value indications; rapid net price erosion follows.

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Key Takeaways

• TAGRISSO’s investment profile is driven by a layered U.S. protection strategy spanning composition-of-matter, formulation/solid-state, and method-of-use claims tied to EGFR-mutated NSCLC settings.
• Generic risk is indication-dependent. Even if one patent bucket is cleared, method-of-use and formulation protections can delay meaningful substitution in revenue-dense patient segments.
• The controlling “earliest competitive date” in valuation is typically a function of Paragraph IV litigation outcomes and settlements, not only patent expiration arithmetic.
• Near-to-mid-term fundamentals remain tied to label durability, sequencing practices, payer net price pressure, and the probability-weighted timeline of any patent-attack success.

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FAQs

1. How do method-of-use patents for osimertinib change generic launch timing by indication?
2. What does an Orange Book listing for TAGRISSO imply about ANDA patent certifications?
3. What is the practical difference between full-label and partial-label generic entry for TAGRISSO?
4. How should investors model settlement-based launch dates versus court-expiration dates?
5. What manufacturing and formulation challenges most often slow generic entrants for solid oral TKIs like osimertinib?

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References

1. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration.
2. FDA. “Drug Approval Reports and Labeling Information for TAGRISSO (osimertinib).” U.S. Food and Drug Administration.
3. Hatch-Waxman Act (HFD/ANDA framework). U.S. Federal Register and FDA guidance materials.