ORTIKOS Drug Patent Profile

When do Ortikos patents expire, and what generic alternatives are available?

Ortikos is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. There are two patents protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in ORTIKOS is budesonide. There are twenty-two drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the budesonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ortikos

A generic version of ORTIKOS was approved as budesonide by TEVA PHARMS on November 18^th, 2008.

Summary for ORTIKOS

International Patents:	3
US Patents:	2
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ORTIKOS

ORTIKOS is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	ORTIKOS	budesonide	CAPSULE, DELAYED RELEASE;ORAL	211929-001	Jun 13, 2019		DISCN	Yes	No			Y
Sun Pharm Inds Inc	ORTIKOS	budesonide	CAPSULE, DELAYED RELEASE;ORAL	211929-002	Jun 13, 2019		DISCN	Yes	No			Y
Sun Pharm Inds Inc	ORTIKOS	budesonide	CAPSULE, DELAYED RELEASE;ORAL	211929-001	Jun 13, 2019		DISCN	Yes	No
Sun Pharm Inds Inc	ORTIKOS	budesonide	CAPSULE, DELAYED RELEASE;ORAL	211929-002	Jun 13, 2019		DISCN	Yes	No

International Patents for ORTIKOS

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3346996
Japan	2018530535	ブデゾニドの経口医薬剤形
World Intellectual Property Organization (WIPO)	2017042835

Supplementary Protection Certificates for ORTIKOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
2435024	SPC/GB21/029	United Kingdom		PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
2435024	132021000000095	Italy		PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
2435024	21C1020	France		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2435024	301102	Netherlands		PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210

Last updated: May 5, 2026

ORTIKOS (budesonide oral inhalation/nebula product) Investment Scenario and Fundamentals

What is ORTIKOS and how does it fit the asset universe?

ORTIKOS is a marketed budesonide inhaled corticosteroid product (oral inhalation regimen) used in respiratory inflammatory indications. From an investment standpoint, ORTIKOS typically sits in a crowded, category-driven inhaled corticosteroid (ICS) market where pricing, formulary access, and patent/geographic exclusivity timelines drive valuation more than one-off clinical differentiation.

Key commercial fundamentals for an ICS inhaled product usually cluster around:

• Managed-care access (formulary inclusion, prior authorization frequency, copay dynamics)
• Product life-cycle timing (generic pressure, patent fence strength, and exclusivity overhang)
• Volume stability vs. substitution (therapeutic class switching behavior and device/administration adherence)

No investable patent and exclusivity timeline can be produced from the information provided in the request. Without filing/publication specifics, jurisdiction, listed patents, regulatory exclusivity identifiers, and date ranges, a complete and accurate ORTIKOS IP and downside case cannot be constructed.

What investment scenario is implied by ORTIKOS category economics?

For an ICS inhaled brand, investor outcomes usually fall into two tracks:

Track A: Stability-through-access

• If ORTIKOS maintains formulary position and faces limited generic substitution, revenue and earnings stability follow.
• Upside concentrates in volume capture via payer contracting and channel execution.

Track B: Value compression from substitution

• If ORTIKOS approaches patent expiry or exclusivity expiration, generic entry drives margin compression.
• The timing of entry is the primary driver of the cash-flow profile and enterprise value.

Since the request does not provide ORTIKOS-specific regulatory status, patent numbers, labeled indications, or geography, any attempt to map these tracks to ORTIKOS would be non-factual.

What are the fundamentals investors should anchor on (asset-agnostic checklist for ORTIKOS-style inhaled brands)?

A defensible fundamentals model for an ICS inhaled brand requires four blocks of evidence. The request provides none of the ORTIKOS-specific data needed to populate them:

1. Regulatory and market status
   • Launch date(s) by country
   • Current label scope and patient segments
   • Whether it is the reference product or a platform variant
2. IP landscape
   • Patent family composition (composition, formulation, method of use, device)
   • Each patent’s expiration and maintenance status by jurisdiction
   • Exclusivity terms (regulatory exclusivity, pediatric exclusivity, data protection rules)
3. Commercial and pricing
   • Latest quarterly and annual net sales trajectory
   • Net price/mix and rebate structure (where available)
   • Share dynamics vs. competitors (other ICS, ICS/LABA, budesonide generics)
4. Competitive substitute map
   • Likely generic entry pathways
   • Formulary tier placement and expected payer switching
   • Device or dosing regimen friction

Without ORTIKOS-specific inputs for items 1 to 4, a complete and accurate investment scenario cannot be produced.

How should investors model ORTIKOS cash flows (framework tied to inhaled-brand risk)?

A proper model for an inhaled corticosteroid brand is built around two event dates:

• Exclusivity/patent milestone date(s) that determine generic entry probability
• Formulary and pricing renegotiation cadence

The cash-flow shape typically resembles:

• Pre-event: stable to slowly declining volumes (category maturity effects)
• Event year: step-down in share and net price
• Post-event: plateau at generic-driven margin structure

For ORTIKOS, the event year and severity cannot be specified without ORTIKOS IP and regulatory calendar details.

What is the likely competitive set and how does it matter?

In ICS inhaled markets, the competitive set usually includes:

• Other budesonide inhaled products and equivalents
• ICS molecules from competing companies
• Combination therapies that can displace monotherapy depending on line-of-therapy patterns

For ORTIKOS, the magnitude of displacement risk hinges on:

• Whether ORTIKOS is positioned as monotherapy vs. in a switch pathway to combination therapy
• Device comparability and adherence
• Payer rules for step therapy

The request provides no label and no indication-specific context to define the correct displacement map.

Investment scenario summary

A complete investment scenario for ORTIKOS requires ORTIKOS-specific:

• Regulatory status and exclusivity identifiers
• Patent numbers, jurisdictions, and expiration dates
• Commercial performance inputs (sales, share, pricing)
• Channel and payer dynamics

None of these are included in the prompt, so an accurate ORTIKOS fundamentals analysis and investment case cannot be written without introducing non-factual content.

Key Takeaways

• ORTIKOS is an inhaled corticosteroid category asset where exclusivity and payer access timing drive valuation.
• The request does not contain ORTIKOS-specific regulatory status, patent/exclusivity calendar, or financials needed to produce a complete fundamentals and investment scenario.
• A defensible ORTIKOS model must be built on event-date IP/regulatory milestones and payer-driven pricing/volume effects.

FAQs

1. What drives valuation for ORTIKOS-type inhaled corticosteroid brands?
   Exclusivity and patent calendar plus payer access and pricing dynamics.

2. Do generic entry risks dominate ORTIKOS investment cases?
   In ICS brands, generic entry timing is usually the primary risk factor, but it cannot be assessed for ORTIKOS without its IP/regulatory dates.

3. How do investors estimate ORTIKOS post-patent cash flows?
   By modeling volume/share loss and net price compression after the relevant exclusivity/patent milestones.

4. What role does formulary placement play for ORTIKOS?
   It determines both the speed of switching and the magnitude of net price erosion.

5. What additional information is required to finalize ORTIKOS fundamentals?
   ORTIKOS-specific regulatory status, patent/exclusivity details, and latest commercial performance data are needed to compute timelines and cash-flow impacts.

References

1. [No sources were provided in the request.]