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-two 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
Raw Ingredient (Bulk) Api Vendors:	67
Patent Applications:	5,828
What excipients (inactive ingredients) are in ORTIKOS?	ORTIKOS excipients list
DailyMed Link:	ORTIKOS at DailyMed

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

EU/EMA Drug Approvals for ORTIKOS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Dr. Falk Pharma GmbH	Jorveza	budesonide	EMEA/H/C/004655 Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).	Authorised	no	no	yes	2018-01-08
Stada Arzneimittel AG	Kinpeygo	budesonide	EMEA/H/C/005653 Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.	Authorised	no	no	yes	2022-07-15

International Patents for ORTIKOS

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

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

Supplementary Protection Certificates for ORTIKOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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	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	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
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210

Market Dynamics and Financial Trajectory for ORTIKOS (Budesonide)

Introduction to ORTIKOS

ORTIKOS (budesonide) is a significant addition to the treatment options for mild to moderate active Crohn’s disease, particularly notable for being the first and only once-daily dose available in the U.S. market. This anti-inflammatory corticosteroid, developed by Ferring Pharmaceuticals, has been approved for patients 8 years and older and is available in 6mg and 9mg doses[1].

Market Need and Patient Demographics

Crohn’s disease is a chronic inflammatory bowel disease affecting approximately 800,000 Americans. The need for effective, convenient, and safe treatments is paramount. Patients with Crohn’s disease seek treatments that not only manage symptoms but also offer ease of use and minimal side effects. ORTIKOS addresses this need by providing a once-daily dosing regimen, which can significantly improve patient compliance and quality of life[1].

Competitive Landscape

The gastroenterology market, particularly for Crohn’s disease treatments, is highly competitive and includes a range of medications such as biologics, immunomodulators, and other corticosteroids. ORTIKOS stands out due to its unique once-daily dosing and its specific targeting of the ileum and/or the ascending colon. This differentiation can attract patients and healthcare providers looking for a more convenient treatment option[1].

Pricing and Accessibility

ORTIKOS is priced competitively, with commercial patients potentially paying as little as $10 for a 30-day supply, depending on the terms and conditions of the patient assistance programs offered by Ferring Pharmaceuticals. This pricing strategy aims to make the medication more accessible to a broader patient population, which can positively impact market penetration and patient adherence[1].

Safety and Efficacy

The safety and efficacy of ORTIKOS have been established through clinical studies. Patients taking budesonide experienced fewer glucocorticosteroid-related side effects compared to prednisolone. Common adverse reactions include headache, respiratory infection, nausea, back pain, and others, but these are generally manageable and reflect the typical side effect profile of corticosteroids[1].

Financial Impact on Healthcare Systems

The introduction of ORTIKOS can have several financial implications for healthcare systems. Given its competitive pricing and the potential for improved patient compliance, it could reduce overall healthcare costs associated with managing Crohn’s disease. For instance, better disease management can lead to fewer hospitalizations and reduced need for other medications or procedures[1].

Market Trends and Drivers

Patient Preferences

Patients are increasingly seeking treatments that offer convenience and minimal disruption to their daily lives. ORTIKOS, with its once-daily dosing, aligns well with these preferences, which can drive market demand.

Regulatory Environment

The FDA's approval process and subsequent market entry of ORTIKOS highlight the regulatory environment's support for innovative treatments that address unmet needs. This regulatory backdrop can facilitate further market growth[5].

Economic Factors

The pharmaceutical market is influenced by economic factors such as price transparency, rebates, and research and development costs. ORTIKOS's pricing strategy and the overall cost-effectiveness of the medication can help navigate these economic complexities[2].

Challenges and Risks

Drug Shortages

While ORTIKOS is currently available, the broader pharmaceutical market is susceptible to drug shortages, particularly for off-patent drugs with low prices. However, as a newer, branded medication, ORTIKOS is less likely to face immediate shortage risks compared to older, generic drugs[3].

Market Competition

The gastroenterology market is highly competitive, with various treatments available. ORTIKOS must continue to differentiate itself through its unique dosing regimen and clinical benefits to maintain market share.

Future Outlook

Expansion of Indications

Ferring Pharmaceuticals may explore expanding the indications for ORTIKOS to include other forms of inflammatory bowel disease or to cover a broader patient population, which could further enhance its market position.

Patient Assistance Programs

Continued investment in patient assistance programs can help maintain affordability and accessibility, which are critical for long-term market success.

Research and Development

Ongoing research and development in the field of gastroenterology could lead to new treatments or formulations that might compete with ORTIKOS. However, the unique profile of ORTIKOS positions it well to remain a viable treatment option.

Key Takeaways

• Market Need: ORTIKOS addresses the need for convenient and effective treatments for mild to moderate Crohn’s disease.
• Competitive Advantage: Once-daily dosing and specific targeting of the ileum and/or ascending colon differentiate ORTIKOS in the market.
• Pricing Strategy: Competitive pricing and patient assistance programs enhance accessibility.
• Safety and Efficacy: Established through clinical studies, with a favorable side effect profile.
• Financial Impact: Potential to reduce overall healthcare costs through better disease management.
• Market Trends: Aligns with patient preferences for convenience and is supported by a favorable regulatory environment.
• Challenges: Must navigate market competition and potential drug shortage risks.

FAQs

Q: What is ORTIKOS used for?

A: ORTIKOS (budesonide) is used for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon in patients 8 years and older, and for the maintenance of clinical remission in adults for up to three months.

Q: How is ORTIKOS administered?

A: ORTIKOS is administered as a once-daily dose, available in 6mg and 9mg capsules.

Q: What are the common side effects of ORTIKOS?

A: Common side effects include headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue, and pain.

Q: How does ORTIKOS compare to other treatments for Crohn’s disease?

A: ORTIKOS is the first and only once-daily treatment for mild to moderate Crohn’s disease, offering a convenient dosing regimen that differentiates it from other treatments.

Q: Is ORTIKOS affordable for patients?

A: Yes, commercial patients may pay as little as $10 for a 30-day supply of ORTIKOS, depending on the terms and conditions of patient assistance programs.

Sources

1. Ferring Pharmaceuticals Inc. - ORTIKOS™ (budesonide), the First and Only Once-Daily Dose for Treatment of Mild to Moderate Crohn’s Disease, Now Available in the U.S.
2. Oregon Department of Consumer and Business Services - Prescription Drug Price Transparency Results and Recommendations.
3. Office of Health Economics - The Dynamics of Drug Shortages.
4. Health.mil - February 2021 DoD PT Committee Meeting Minutes.
5. FDA - FY 2019 PDUFA Performance Report.