IRESSA Drug Patent Profile

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

Iressa is a drug marketed by Astrazeneca and is included in two NDAs.

The generic ingredient in IRESSA is gefitinib. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the gefitinib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Iressa

A generic version of IRESSA was approved as gefitinib by QILU PHARM HAINAN on February 13^th, 2023.

Summary for IRESSA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	155
Clinical Trials:	233
Drug Prices:	Drug price information for IRESSA
What excipients (inactive ingredients) are in IRESSA?	IRESSA excipients list
DailyMed Link:	IRESSA at DailyMed

See drug prices for IRESSA

Recent Clinical Trials for IRESSA

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

Sponsor	Phase
Beta Pharma, Inc.	Phase 3
Second Affiliated Hospital of Nanchang University	Phase 2
Nanchang University	Phase 2

See all IRESSA clinical trials

Pharmacology for IRESSA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

US Patents and Regulatory Information for IRESSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003		DISCN	No	No
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015	AB	RX	Yes	Yes

Expired US Patents for IRESSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015

EU/EMA Drug Approvals for IRESSA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Gefitinib Mylan	gefitinib	EMEA/H/C/004826Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) with activating mutations of EGFR‑TK.	Authorised	yes	no	no	2018-09-27
AstraZeneca AB	Iressa	gefitinib	EMEA/H/C/001016Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase.	Authorised	no	no	no	2009-06-24

International Patents for IRESSA

See the table below for patents covering IRESSA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	130000
Australia	3101093
Australia	661533
Canada	2086968	DERIVES DE QUINAZOLINE (QUINAZOLINE DERIVATIVES)

Supplementary Protection Certificates for IRESSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0823900	PA2009009	Lithuania		PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
0823900	91631	Luxembourg		91631, EXPIRES: 20210423
0823900	CA 2009 00051	Denmark
0823900	PA2009009,C0823900	Lithuania		PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624

Last updated: July 25, 2026

IRESSA (gefitinib) market dynamics and financial trajectory: exclusivity cliff, generic/biosimilar risk, and revenue exposure

IRESSA (gefitinib) is a first-generation EGFR TKI launched for EGFR-mutated non-small cell lung cancer (NSCLC). The drug’s market position shifted from branded exclusivity to sustained price pressure as gefitinib generics entered key markets and treatment standards moved toward newer EGFR inhibitors and sequencing strategies. Net commercial performance now tracks guideline use, EGFR testing penetration, regional formulary access, and the remaining headroom in patients who still receive gefitinib under payer and clinician practice patterns.

How has IRESSA (gefitinib) performed commercially since launch?

Answer: IRESSA’s branded peak was followed by a steady decline driven by generic competition and evolving NSCLC treatment patterns.

Revenue trajectory drivers

• Loss of patent exclusivity in major markets reduced branded share as low-cost generics entered.
• Line-of-therapy shifts: clinical practice moved toward second-generation TKIs and later sequencing frameworks (especially where resistance mechanisms are addressed with newer agents).
• Formulary and reimbursement behavior: payers increasingly preferred lower-cost EGFR TKIs once interchangeable generic options were available.
• EGFR testing expansion: greater testing increased the pool of EGFR-mutant patients overall, but that growth did not translate into branded share once generics competed.

Clinical demand factors that still support volumes

• EGFR-mutated NSCLC remains a large and recurring oncology segment where oral TKIs are central.
• IRESSA can still have utility in selected populations depending on region, prior therapy, tolerability, and pricing access.

What patents protect IRESSA (gefitinib) and how strong is the estate?

Answer: IRESSA’s effective freedom-to-operate is primarily determined by the expiration of composition and formulation patents in each jurisdiction, plus any later-life patents (crystallinity/polymorph, salts, specific formulations) that can delay generic entry for certain presentations.

Patent estate structure typically seen for EGFR TKIs

• Core composition of matter (gefitinib)
• Formulations (tablet compositions, excipients, film coatings, manufacturing controls)
• Medical use (specific EGFR-mutant patient subsets, lines of therapy, combination regimens)

Why “patent strength” matters less now

Branded market dynamics for IRESSA are dominated by:

• the broad availability of gefitinib generics across many markets, and
• treatment standard evolution away from older-generation TKIs.

In practice, the “strength” of any remaining late-life patents mostly affects product routing for specific national SKUs, not the overall global brand trajectory.

When does IRESSA lose exclusivity in the US, EU, and key Asia markets?

Answer: IRESSA exclusivity ended in major jurisdictions well before current date as composition/formulation protections expired and generics launched.

Exclusivity timeline mechanics

Key exclusivity outcomes typically include:

• US patent expiration for composition/formulation claims listed in the Orange Book (where applicable)
• Generic market entry via ANDA pathways using bioequivalence
• Any pediatric exclusivity, if present, which can add time to patent-based exclusivity

Operational takeaway

For business planning, the actionable view is no longer “when does IRESSA exclusivity end?” but “which remaining branded or branded-labeled presentations retain differentiation by region,” if any.

What is the Orange Book status of IRESSA (gefitinib) and which patents are listed?

Answer: Branded IRESSA’s Orange Book listings historically reflected composition/formulation patents, but the practical outcome is that generic versions are widely available.

Why Orange Book status matters now

Even when Orange Book listings persist, the real market question becomes:

• whether any listed patents remain enforceable and
• whether a specific formulation strength or label claim is still protected.

How many generic entrants compete with IRESSA, and where are they most disruptive?

Answer: The competition footprint is broad across jurisdictions where gefitinib is genericized, with disruption strongest in pricing-sensitive markets and channels where payers prefer formulary cheapest options.

Market disruption pattern

• Initial generic entry leads to rapid price compression versus branded IRESSA.
• Subsequent entrants extend downward pricing until channel margins stabilize.
• Switching inertia declines as pharmacists and payers standardize on generic.
• Tender and hospital procurement often accelerate share transfer.

What generic entry risks exist for IRESSA (gefitinib) from Paragraph IV challenges?

Answer: Paragraph IV challenges are relevant where branded Orange Book patents are still listed and presumed enforceable. For IRESSA, the more important question is not “risk of first generic entry,” but “risk of subsequent market share erosion through additional ANDA filings and price competition.”

Business interpretation

• If any late-life patents remain in a jurisdiction for a specific SKU or label, that can delay certain generic launches.
• Once generics are established, new ANDAs typically do not create “binary” risks like early Paragraph IV settlements do; they add margin pressure.

What biosimilar risk exists for IRESSA (gefitinib)?

Answer: None in the biosimilar sense because gefitinib is a small-molecule drug, not a biologic.

How does IRESSA compare with competing EGFR TKIs (erlotinib, osimertinib, afatinib, dacomitinib) on market positioning?

Answer: IRESSA is an older EGFR TKI and faces structural competition from second- and third-generation agents that capture larger portions of modern EGFR-mutant NSCLC treatment sequences.

Competitive dynamics by segment

• First-line EGFR-mutated NSCLC: modern practice increasingly favors later-generation TKIs depending on mutation profile and guideline updates.
• Resistance and sequencing: later agents and combination strategies address acquired resistance mechanisms more effectively, shifting prescribing patterns away from first-generation TKIs.
• Regional prescribing: in some lower-cost settings or where newer agents are not reimbursed, older EGFR TKIs can retain use.

What formulations are protected for IRESSA (gefitinib), and do generics copy those protected aspects?

Answer: Protected elements in formulation patents usually target specific tablet compositions, coatings, particle size or polymorph controls, and manufacturing methods. Generics generally pursue bioequivalent approaches using approved formulations under ANDA frameworks rather than copying protected process details where still enforceable.

Actionable implications

• If any formulation patents remain enforceable for a specific strength or presentation, they can constrain “at-risk” generic launch timing in that country.
• Most market share loss, however, occurs once generic alternatives are approved and priced aggressively.

What patent litigation affects IRESSA (gefitinib), and what settlement outcomes matter?

Answer: Patent litigation outcomes historically determined “when” and “which” generics could launch. For IRESSA, widespread generic access indicates that major enforceability hurdles have largely been resolved or expired.

What to track for residual risk

• Enforcement actions tied to specific formulation patents
• Injunctions affecting specific strengths
• Settlement agreements that delay launch dates for certain ANDA filers

What FDA regulatory pathway governs IRESSA and its generics?

Answer: Branded IRESSA is approved via NDA. Generic versions are approved through ANDA relying on bioequivalence to the reference listed drug.

Commercial consequence

• ANDA approvals accelerate price competition and reinforce the shift from brand to generic spend.
• Uptake is driven by pharmacy substitution laws, wholesaler distribution, and payer formulary status.

How do guideline updates and mutation testing affect IRESSA demand?

Answer: EGFR testing is necessary to identify eligible patients, but guideline evolution affects whether older TKIs remain preferred.

Key demand constraints

• The size of the EGFR-mutated NSCLC population supports volume, but:
• selection among TKIs depends on mutation subtype and prior therapy,
• later-generation TKIs often displace older ones.

What is the current commercial exposure of IRESSA to price erosion and volume substitution?

Answer: High exposure to price erosion post-generic entry, with offset from stable EGFR-mutant patient demand but limited offset from branded share recovery.

How the P&L typically looks in branded-to-generic transition

• Gross margin declines sharply after generic substitution
• Revenue becomes dependent on:
  • remaining branded formulations with limited alternatives,
  • contract pricing with payers,
  • specific clinical preferences in constrained markets.

Which companies benefit from gefitinib generic competition, and how does that shift bargaining power?

Answer: Generic manufacturers and authorized distributors in each jurisdiction capture incremental share as payers and providers switch to lower-cost options, reducing the branded holder’s pricing leverage.

Bargaining power shift

• Once multiple ANDA-labeled competitors exist, price becomes a procurement lever.
• Branded holders typically survive via:
  • limited remaining differentiation,
  • negotiated contracts,
  • niche channel retention.

What market dynamics could revive IRESSA brand value despite generics?

Answer: Revivals are mostly localized and depend on pricing contracts, label expansion in constrained geographies, or payer-specific reimbursement decisions.

Revival mechanisms that can still work

• Formulary re-listing if newer alternatives are restricted by reimbursement
• Tender-based wins where the brand price is competitively renegotiated
• Regional differences in generic penetration timing

Key takeaways

• IRESSA’s market trajectory follows a classic first-generation branded-to-generic pattern: exclusivity ended in major markets and generic gefitinib now drives ongoing price pressure.
• Commercial demand remains supported by the EGFR-mutant NSCLC segment, but guideline and sequencing shifts have reduced the brand’s share potential versus later-generation EGFR TKIs.
• Patent and regulatory factors now matter mainly at the country/SKU level rather than for global brand survival.
• Financial outlook is dominated by generics-led pricing erosion, with only limited local opportunities to protect branded revenue through contracts or reimbursement structures.

FAQs

1. Does gefitinib have biosimilar competition risk?
   No. Gefitinib is a small molecule, so the biosimilar framework does not apply.

2. Do generic gefitinib products fully substitute for IRESSA in real-world prescribing?
   In many markets, yes, once approved and formulary-listed, with substitution accelerating through procurement and pharmacy policies.

3. What EGFR mutations or clinical settings still favor older EGFR TKIs like gefitinib?
   Use depends on regional practice, prior therapies, and mutation subtype; newer TKIs tend to capture more modern lines where reimbursed.

4. Can formulation patents still delay generic entry for specific IRESSA strengths?
   They can in jurisdictions where late-life formulation or manufacturing patents remain enforceable for that strength/presentation.

5. What is the biggest financial risk for IRESSA commercialization going forward?
   Ongoing price compression from additional generic entrants and continued shifts in prescribing toward later-generation EGFR inhibitors.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (gefitinib / IRESSA entries).
2. FDA. ANDA and reference listed drug/bioequivalence regulations and guidance documents.
3. Clinical guideline sources for EGFR-mutant NSCLC treatment sequencing (regional updates and therapy selection frameworks).
4. Peer-reviewed literature on EGFR TKI sequencing and resistance in NSCLC (comparative efficacy across generations).

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