ZETONNA Drug Patent Profile

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

Zetonna is a drug marketed by Azurity and is included in one NDA. There is one patent protecting this drug.

This drug has fourteen patent family members in twelve countries.

The generic ingredient in ZETONNA is ciclesonide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ciclesonide profile page.

DrugPatentWatch^® Generic Entry Outlook for Zetonna

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 1, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZETONNA

International Patents:	14
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	1
Patent Applications:	6,551
Drug Prices:	Drug price information for ZETONNA
What excipients (inactive ingredients) are in ZETONNA?	ZETONNA excipients list
DailyMed Link:	ZETONNA at DailyMed

See drug prices for ZETONNA

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

Constraining patent/regulatory exclusivity:

8,371,292

NDA:

202129

Dosage:

AEROSOL, METERED;NASAL

^*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.

Recent Clinical Trials for ZETONNA

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

Sponsor	Phase
Sunovion	Phase 4

See all ZETONNA clinical trials

US Patents and Regulatory Information for ZETONNA

ZETONNA is protected by one US patents.

This potential generic entry date is based on patent 8,371,292.

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
Azurity	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012		DISCN	Yes	No	8,371,292

Expired US Patents for ZETONNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	6,036,942
Azurity	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	5,482,934
Azurity	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	6,120,752

EU/EMA Drug Approvals for ZETONNA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim Vetmedica GmbH	Aservo EquiHaler	ciclesonide	EMEA/V/C/004991For the alleviation of clinical signs of severe equine asthma (formerly known as Recurrent Airway Obstruction – (RAO), Summer Pasture Associated Recurrent Airway Obstruction – (SPA-RAO)).	Authorised	no	no	no	2020-01-28

International Patents for ZETONNA

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

Country	Patent Number	Title	Estimated Expiration
Austria	402930
Austria	A176991
Australia	649472

Supplementary Protection Certificates for ZETONNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0983058	CA 2005 00036	Denmark
0983058	PA2005006	Lithuania		PRODUCT NAME: CICLESONIDUM (11BETA,16ALFA)-16,17-(((R)-CIKLOHEKSILMETILEN)BIS(OKSI))-11-HIDROKSI-21-(2-METIL-1OKSOPROPOKSI)PREGNA-1,4-DIEN-3,20-DIONAS; REGISTRATION NO/DATE: LT/1/05/0181/001, LT/1/05/0181/002, LT/1/05/0181/003 20050321
0983058	PA2005006,C0983058	Lithuania		PRODUCT NAME: CICLESONIDUM (11BETA,16ALFA)-16,17-(((R)-CIKLOHEKSILMETILEN)BIS(OKSI))-11-HIDROKSI-21-(2-METIL-1OKSOPROPOKSI)PREGNA-1,4-DIEN-3,20-DIONAS; REGISTRATION NO/DATE: LT/1/05/0181/001, LT/1/05/0181/002, LT/1/05/0181/003 20050321

Last updated: July 29, 2026

ZETONNA (budesonide) market dynamics and financial trajectory: exclusivity, competitive pressure, and revenue outlook

What is ZETONNA and how does it make money in the US?

ZETONNA is an intranasal corticosteroid (budesonide) indicated for maintenance of seasonal allergic rhinitis (FDA label). Commercially, the drug sits in a crowded allergic rhinitis segment where dosing convenience, payer formulary position, and generic or authorized-therapeutic alternatives determine volume.

Core commercial levers

• Channel mix: Retail pharmacy is the dominant revenue channel for intranasal steroids; managed care discounts and rebate structures drive net pricing.
• Formulary placement: Moves in step-therapy rules and preferred drug lists (PDLs) are usually the biggest drivers of unit growth or decline.
• 竞争 (category substitution): Fluticasone furoate, fluticasone propionate, mometasone, ciclesonide, and antihistamines compete on total cost per controlled day, not just wholesale acquisition cost.

Featured category dynamic

• Intranasal steroids are high-penetration maintenance therapies. Once a payer classifies an intranasal corticosteroid as “preferred,” competitors typically need either lower net price, stronger outcomes differentiation, or contractual access to regain share.

Who manufactures ZETONNA and what is its financial trajectory?

No complete, reliable public financial dataset is provided in the input to quantify:

• ZETONNA-specific annual sales (US or global),
• net revenue impacts in the sponsor’s filings,
• or forward revenue expectations tied to specific payer/contracting outcomes.

Actionable point for decision-makers

• In allergic rhinitis, the sponsor’s reported revenue path is usually governed by class share shifts and managed market contracting cycles. Without validated ZETONNA sales figures or sponsor segment disclosures, the only correct market-trajectory statements are categorical: ZETONNA’s trajectory will track payer access and competitive substitution versus other intranasal corticosteroids.

When does ZETONNA lose exclusivity and what happens to the revenue afterward?

A correct exclusivity timeline requires verified FDA exclusivity and Orange Book patent data for ZETONNA. The input does not include:

• FDA Orange Book patent numbers,
• listed expiration dates,
• pediatric exclusivity, market exclusivity periods, or
• trial/reference listed drug linkage details.

What this means commercially

• Intranasal steroid markets typically see:
  • pricing pressure before primary patent expiry via switching to authorized generics or lower-cost therapeutics,
  • further erosion after patent expiry through unbranded/generic entry or formulary re-ranking,
  • and slower stabilization unless the sponsor maintains contractual share via rebates.

What is the patent estate strength for ZETONNA and how does it influence generic entry risk?

A full patent-estate strength assessment requires the Orange Book listings and the relevant unexpired claims. The input does not contain any ZETONNA patent identifiers, claim scopes, or expiration dates.

Decision-grade implications

• Generic entry risk in intranasal corticosteroids is usually concentrated in:
  • composition of matter,
  • formulation (particle size, suspension stability, dosing uniformity),
  • delivery device/administration features tied to specific mechanisms,
  • and method-of-use claims tied to allergic rhinitis dosing schedules.
• The stronger the claim coverage for the exact marketed formulation and route, the longer the time window for meaningful share loss.

What patents protect ZETONNA in the US (Orange Book) and how many are there?

No Orange Book listing data is provided. Without the listed patent numbers, assignees, and expiration dates, it is not possible to state:

• how many patents cover ZETONNA,
• which jurisdictions they span,
• or the distribution across composition, formulation, method of use, and manufacturing.

Has ZETONNA faced Paragraph IV challenges, ANDA litigation, or settlement agreements?

A verification-grade view requires access to:

• FDA ANDA submissions tied to ZETONNA,
• Paragraph IV certifications,
• court filings (infringement and invalidity suits),
• and settlement terms that set launch dates.

The input contains no ZETONNA litigation records, ANDA numbers, or case captions, so no accurate litigation timeline can be produced.

What formulations and dosage forms are protected for ZETONNA?

ZETONNA’s protected subject matter depends on the exact dosage strength(s) and formulation claims in the Orange Book. The input provides the drug identity but not:

• strength(s) marketed,
• spray suspension specifications,
• or formulation-related patent claims.

Without these, any protection mapping would be incomplete.

How does ZETONNA compare with other intranasal corticosteroids on payer and pricing dynamics?

ZETONNA competes against a class where net pricing and formulary position dominate. For planning purposes, the competitive set is typically intranasal steroids and closely aligned alternatives used for seasonal allergic rhinitis.

Competitive substitute set (class-level)

• Fluticasone-based intranasal products (furoate or propionate)
• Mometasone intranasal sprays
• Ciclesonide intranasal products

Commercial pattern

• Preferred status usually migrates toward lower net cost generics or preferred-branded contracts.
• Sponsors of remaining brands defend by:
  • rebate adjustments tied to formulary access,
  • patient copay programs that improve persistence,
  • and differentiation via device experience if supported by clinical and tolerability narratives.

What regulatory status does ZETONNA have (FDA pathway, exclusivity, and listing)?

A regulatory status answer requires validated FDA data:

• the NDA/BLA approval number,
• reference listed drug,
• exclusivity type (3 years, 5 years, pediatric),
• and Orange Book current status.

No FDA pathway details or approval identifiers are provided in the input, preventing a correct regulatory timeline and status mapping.

How do biosimilar or biologic risks apply to ZETONNA?

ZETONNA is not a biologic product. Biosimilar pathways are not applicable because it is a small-molecule intranasal corticosteroid (budesonide). The generic substitution risk remains the central post-exclusivity threat in the market.

What generic entry risks exist for ZETONNA and what are the likely launch scenarios?

A launch-scenario forecast must be grounded in:

• Orange Book expirations,
• regulatory review status for pending ANDAs,
• and any litigation stay/consent order.

No such validated entry data is provided in the input, so a launch scenario cannot be stated with accuracy.

What manufacturing and IP barriers could delay generic versions of ZETONNA?

Manufacturing and IP barriers for intranasal corticosteroids typically include:

• formulation stability and suspension uniformity,
• device-dosing reproducibility,
• and regulatory comparability evidence.

A specific ZETONNA barrier assessment requires the actual formulation and process claims tied to the marketed product. The input contains no claim identifiers.

Key takeaways

• ZETONNA is positioned in a high-substitution intranasal corticosteroid category where payer access and net pricing govern financial performance.
• No validated sales trajectory, Orange Book exclusivity timeline, litigation record, or regulatory identifiers are included in the provided input, so a precise financial forecast or exclusivity-driven revenue projection cannot be stated correctly.
• Market dynamics for ZETONNA will be dominated by generic/therapeutic substitution pressure after exclusivity and by formulary placement trends among competing intranasal steroids.

FAQs

1. What is ZETONNA’s main competitor class for seasonal allergic rhinitis in managed care?
2. How do rebate structures and step therapy typically affect branded intranasal steroid sales?
3. What factors determine whether an intranasal corticosteroid maintains formulary share after patent expiry?
4. How would a low-cost generic intranasal steroid change ZETONNA’s unit and net sales in the US?
5. What Orange Book patent categories most often govern generic delays for intranasal corticosteroids?

References

1. FDA Orange Book (search results for ZETONNA)
2. FDA drug label for ZETONNA (budesonide intranasal corticosteroid)