DALIRESP Drug Patent Profile

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

Daliresp is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in DALIRESP is roflumilast. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Daliresp

A generic version of DALIRESP was approved as roflumilast by SENORES PHARMS on October 3^rd, 2018.

Summary for DALIRESP

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	17
Patent Applications:	6,999
Drug Prices:	Drug price information for DALIRESP
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DALIRESP
What excipients (inactive ingredients) are in DALIRESP?	DALIRESP excipients list
DailyMed Link:	DALIRESP at DailyMed

See drug prices for DALIRESP

Recent Clinical Trials for DALIRESP

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

Sponsor	Phase
Chiesi Farmaceutici S.p.A.	Phase 3
Johns Hopkins University	Phase 3
Patient-Centered Outcomes Research Institute	Phase 3

See all DALIRESP clinical trials

Pharmacology for DALIRESP

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Paragraph IV (Patent) Challenges for DALIRESP

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DALIRESP	Tablets	roflumilast	250 mcg	022522	1	2019-01-25
DALIRESP	Tablets	roflumilast	500 mcg	022522	7	2015-03-02

US Patents and Regulatory Information for DALIRESP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	AB	RX	Yes	No
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	AB	RX	Yes	Yes

Expired US Patents for DALIRESP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011

EU/EMA Drug Approvals for DALIRESP

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Daxas	roflumilast	EMEA/H/C/001179Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.,	Authorised	no	no	no	2010-07-05
AstraZeneca AB	Libertek	roflumilast	EMEA/H/C/002399Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.	Withdrawn	no	no	no	2011-02-28
AstraZeneca AB	Daliresp	roflumilast	EMEA/H/C/002398Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.	Withdrawn	no	no	no	2011-02-28

International Patents for DALIRESP

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

Country	Patent Number	Title	Estimated Expiration
Austria	217612
Australia	687087
Australia	7490794
Canada	2165192	DERIVES DE SUBSTITUTION FLUOROALCOXY DE BENZAMIDES ET LEUR UTILISATION COMME INHIBITEURS DE LA NUCLEOTIDE PHOSPHODIESTERASE CYCLIQUE (FLUOROALKOXY-SUBSTITUTED BENZAMIDES AND THEIR USE AS CYCLIC NUCLEOTIDE PHOSPHODIESTERASE INHIBITORS)

Supplementary Protection Certificates for DALIRESP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0706513	91709	Luxembourg		91709, EXPIRES: 20190702
0706513	C300462	Netherlands		PRODUCT NAME: ROFLUMILAST, DESGEWENST IN DE VORM VAN HET N-OXIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
0706513	CA 2010 00028	Denmark
0706513	SPC031/2010	Ireland		SPC031/2010: 20110906, EXPIRES: 20190701

DALIRESP (roflumilast) Market Dynamics and Financial Trajectory: Exclusivity Timeline, Competition Risk, and Revenue Outlook

Last updated: July 21, 2026

DALIRESP (roflumilast) is an inhaled-targeted chronic obstructive pulmonary disease (COPD) product sold as oral tablets (Daliresp 250 mcg and 500 mcg, once daily). The financial trajectory is driven by (1) a shrinking premium branded runway versus generics, (2) payer and formulary pressure in COPD maintenance, (3) switching dynamics after loss of brand exclusivity, and (4) lifecycle events tied to label positioning for chronic bronchitis and exacerbation reduction. In the US, DALIRESP’s branded economics are constrained by the drug’s age and generic availability, with residual brand sales supported mainly by formulary entrenchment, patient persistence, and channel mix rather than protected IP.

---

What drives DALIRESP (roflumilast) market dynamics in COPD maintenance?

Direct answer: DALIRESP’s market position depends on exacerbation reduction in severe COPD with chronic bronchitis, oral dosing adherence, and payor coverage. Commercial gains and losses tend to track formulary tiering, copay outcomes, and competition from alternative COPD exacerbation-prevention regimens (inhaled LAMA/LABA, LABA+ICS, and triple therapy) that compete for the same patient segments and line-of-therapy budgets.

Key demand levers

• Patient selection: DALIRESP is typically targeted to COPD patients with chronic bronchitis and a history of exacerbations. Outcomes depend on maintaining consistent dosing.
• Exacerbation economics: Payers evaluate whether adding roflumilast reduces costly exacerbations enough to justify placement relative to inhaled regimens.
• Oral vs inhaled preference: Oral once-daily dosing reduces device friction but can face adherence and tolerability barriers.
• Tolerability profile: Weight loss, gastrointestinal effects, and psychiatric adverse events affect persistence. That directly impacts long-term revenue and payer confidence.
• Guideline placement: Clinical adoption is shaped by guideline language on chronic bronchitis with frequent exacerbations, often as an add-on when inhaled options are insufficient.

Competitive substitution pressure

• Inhaler-based escalation: COPD exacerbation prevention is heavily addressed by inhaled combinations. As inhaler adoption rises, oral add-ons face harder formulary justification.
• Broad generic competition: In markets where roflumilast generics are established, branded DALIRESP competes mainly on marketing spend, patient support, and contracting rather than on differentiation.

---

How has DALIRESP’s financial trajectory evolved as roflumilast generics expanded?

Direct answer: DALIRESP’s revenue profile follows the classic branded-to-generic pattern: high share earlier, followed by erosion after generic entry and intensified rebate pressure. Remaining branded revenue typically persists through payer mix and contracting for continuity, not through durable patent protection that would block generics.

Revenue phase structure (typical pattern for an aged branded COPD oral)

1. Pre-generic consolidation: Branded product captures COPD add-on demand for exacerbation reduction.
2. Generic entry and tiering shift: Brand loses preferred formulary status or sees increased patient cost-sharing.
3. Channel and persistence effects: Brand maintains a residual share where “no switch” contracts, physician continuity, or patient assistance programs reduce switching.
4. Margin compression: Even if units remain stable, branded net revenue declines due to rebates, support programs, and contracting.

Bottom-line drivers of profit

• Net price compression: Generic substitution drives brand pricing toward the cost structure of competing generics plus higher rebate intensity.
• Sales force efficiency: Commercial spending scales down or shifts toward payer contracting and retention.
• Mix shift between 250 mcg and 500 mcg: Dose-level mix affects average selling price (ASP) and treatment persistence.

(A precise annual revenue chart requires company filings and/or syndicated datasets. The market direction is consistent with roflumilast’s generic availability and the age of the product.)

---

What is the Orange Book status of DALIRESP (roflumilast) and what does it imply for market exclusivity?

Direct answer: The Orange Book status for roflumilast-containing products in the US generally indicates multiple listed patents with varying expiration dates, but branded exclusivity has materially reduced in practice due to generic approvals and entry. For investors, the critical implication is that DALIRESP’s US revenue ceiling is tied to (1) when patent protections expired and (2) whether any later-listed formulation or method claims remain enforceable against generic manufacturing or labeling.

How Orange Book entries translate into commercial timing

• If composition-of-matter expires: generics can enter via Paragraph IV/ANDA pathways subject to patent challenges and litigation outcomes.
• If formulation/method-of-use patents remain: they can delay certain generic labeling or require carve-outs, but do not stop entry once all relevant blocking patents are cleared.

Practical exclusivity takeaway

Because roflumilast is an established oral COPD maintenance therapy with ongoing generic competition, the branded market impact is primarily post-exclusivity. That compresses branded pricing and sustains a “residual brand share” rather than a long protected runway.

---

When does DALIRESP (roflumilast) lose exclusivity in the US and key global markets?

Direct answer: DALIRESP’s exclusivity has effectively moved into post-patent and post-brand-advantage territory in most major markets. The US and EU timelines should be analyzed against Orange Book patent listings and local SPC (supplementary protection certificate) regimes where applicable.

US timing checkpoints to track

• Patent expirations for any listed blocking claims
• Any pediatric exclusivity extensions (if applicable to relevant patents)
• Any settlement agreements affecting authorized generic launch timing
• Date of generic approvals and any “launch-at-risk” behavior

EU/UK and global timing checkpoints

• SPC effective dates and end dates
• National patent term adjustments
• Litigation outcomes affecting local generic entry

(A jurisdiction-by-jurisdiction exclusivity table requires specific Orange Book and patent/SPC listing dates for each DALIRESP NDA strength and each relevant claim.)

---

What patent estate protects DALIRESP (roflumilast) formulations, methods, and label claims?

Direct answer: The patent estate for roflumilast typically spans composition claims, formulation-related claims, and method-of-use claims focused on COPD treatment and exacerbation reduction. The practical commercial impact is strongest when formulation or method-of-use claims restrict generic labeling or manufacturing processes.

Patent estate categories to assess for enforcement strength

• Composition and polymorph protections (composition-of-matter)
• Formulation protections (tablet composition, excipient system, manufacturing process)
• Method-of-use protections (treatment of COPD with chronic bronchitis, exacerbation reduction)
• Regulatory exclusivity layers (only relevant if still active for brand, usually time-limited)

Why estate strength matters for pricing

If any patent family still blocks generic labeling or requires litigation to clear, brand pricing can stay higher for longer. If claims are cleared, pricing rapidly normalizes to generic levels.

---

What generic entry risks exist for DALIRESP (roflumilast) in the US under Paragraph IV ANDA?

Direct answer: Generic entry risk has already materialized as ANDA approvals and market entry have reduced branded economics. Residual risk now is mainly around additional ANDAs launching with alternative strengths, packaging configurations, or at-risk challenges to remaining listed patents.

Paragraph IV impacts that matter commercially

• Authorized generic vs non-authorized generic launch
• Settlement terms (timing of launch, market allocation, labeling restrictions)
• “Design around” strategies to avoid infringement on formulation/method claims
• Switching friction and payer contracting behavior after generic entry

---

Which companies have challenged or launched roflumilast generics affecting DALIRESP sales?

Direct answer: A complete, company-specific list requires mapping each ANDA approval to the filing entity and then tying it to Orange Book patent challenge records and litigation dockets. Without that mapping, any named list risks being incomplete.

---

What DALIRESP (roflumilast) litigation history affects generic launch timing?

Direct answer: For DALIRESP, the litigation impact is assessed through (1) whether Paragraph IV challenges were filed, (2) whether cases reached final judgment or settled, and (3) whether settlements included delayed-launch or licensing provisions that preserved branded share temporarily.

Litigation-to-commercial linkage

• Case outcomes that delay entry keep branded net price higher longer
• Early settlements typically create a defined launch date for generics
• Adverse rulings accelerate generic normalization and worsen branded revenue

(A litigation table with case numbers, courts, settlement dates, and outcomes requires case docket data.)

---

How does DALIRESP compare with competing COPD therapies on market positioning and cost-effectiveness?

Direct answer: DALIRESP competes as an oral add-on or maintenance option for COPD patients with chronic bronchitis and frequent exacerbations, typically in a segment where inhaled regimens are the first-line maintenance backbone. In practice, budget impact and payer approval turn on whether roflumilast meaningfully reduces exacerbations relative to inhaler regimens and switching costs.

Substitution map

• LAMA/LABA and LAMA/LABA/ICS: main inhaled competitors for exacerbation reduction.
• Triple therapy: often captures patients who might otherwise receive additional oral add-ons.
• Other oral/adjunct therapies (where used): less central than inhaled options but can influence formulary tiering.

What payers weigh

• incremental exacerbation reduction
• adherence and persistence
• side-effect management costs
• patient-level contraindications

---

What dosing and formulation factors influence DALIRESP unit demand and persistence?

Direct answer: Unit demand is driven by once-daily dosing and indication fit. Persistence is constrained by tolerability, including weight loss and neuropsychiatric adverse effects risk, which can increase discontinuation and reduce refill rates.

Strength and dosing dynamics

• 250 mcg and 500 mcg tablet strengths affect prescribing patterns by tolerability and guideline alignment.
• Titration and patient monitoring influence discontinuation risk.
• Real-world adherence tends to be sensitive to side effects, which affects long-term revenue more than initial prescriptions.

---

What are the current commercial economics for DALIRESP (roflumilast) in the US: pricing, rebates, and volume?

Direct answer: Brand-level economics are driven by net price after rebates and patient assistance, with volume supported by payer access and physician continuity. In post-generic environments, net revenues per unit usually compress even when unit demand stabilizes.

Main levers affecting net revenue

• formulary tiering (preferred vs non-preferred)
• copay and prior authorization requirements
• rebate intensity by contracting cycle
• patient assistance targeting (if used)
• switching behavior after generic launches

(A numeric US ASP and prescription volume series requires specific dataset inputs.)

---

How will DALIRESP’s revenue be exposed to future biosimilar or biologic competition?

Direct answer: Biosimilar risk is not the central threat for DALIRESP because roflumilast is a small-molecule oral drug. The major competitive threat is therapeutic substitution within COPD care rather than biosimilar entry.

What can shift risk instead

• guideline changes that move chronic bronchitis add-on therapy earlier or later in the regimen
• payer coverage shifts that steer patients toward preferred inhaled regimens
• new small-molecule or device-adjacent COPD therapies

---

What strategic options exist for DALIRESP brand stakeholders post-exclusivity?

Direct answer: Post-exclusivity strategies focus on contracting, patient retention, and differentiated service where possible, since IP-driven protection is limited.

Common post-exclusivity playbooks

• payer contracting to defend residual formulary position
• patient support to reduce discontinuation
• pharmacy channel programs to maintain share
• line extensions or lifecycle adjustments only where legally viable

---

Key Takeaways

• DALIRESP’s market dynamics are primarily governed by COPD guideline placement for chronic bronchitis patients with exacerbation history, and by payer formulary behavior that shifts as roflumilast generics expand.
• The financial trajectory is consistent with post-exclusivity branded compression: unit share can persist, but net revenue declines due to generic competition, rebate pressure, and switching.
• Future risk is less about patent-to-generic blocking from a clean-room standpoint and more about continued normalization of pricing and therapeutic substitution by preferred inhaled regimens.
• Biosimilar threats are not structurally relevant for roflumilast; competition is therapeutic and formulary-driven.

---

FAQs

1. Why does DALIRESP (roflumilast) underperform in some COPD formularies compared with inhaled triple therapy?
2. How do weight loss and psychiatric adverse events affect DALIRESP persistence and long-term revenue?
3. What are the main drivers of net price erosion for DALIRESP after generic roflumilast entry?
4. How do formulation strength mix (250 mcg vs 500 mcg) change ASP and prescription stability?
5. What settlement terms in roflumilast ANDA cases most affect brand share and timing of generic launches?

---

References (APA)

1. FDA Orange Book. Drug Products (Listed Drugs). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. prescribing information for DALIRESP (roflumilast). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
3. Global COPD management guidance (GOLD). Global Initiative for Chronic Obstructive Lung Disease. https://goldcopd.org/