ISTURISA Drug Patent Profile

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Which patents cover Isturisa, and when can generic versions of Isturisa launch?

Isturisa is a drug marketed by Recordati Rare and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in ISTURISA is osilodrostat phosphate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the osilodrostat phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Isturisa

Isturisa was eligible for patent challenges on March 6, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2035. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for ISTURISA

US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	1
Drug Prices:	Drug price information for ISTURISA
What excipients (inactive ingredients) are in ISTURISA?	ISTURISA excipients list
DailyMed Link:	ISTURISA at DailyMed

See drug prices for ISTURISA

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

NDA:

212801

Dosage:

TABLET;ORAL

^*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 ISTURISA

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

Sponsor	Phase
Johns Hopkins University	PHASE4

See all ISTURISA clinical trials

Pharmacology for ISTURISA

Drug Class	Cortisol Synthesis Inhibitor
Mechanism of Action	Cytochrome P450 11B1 Inhibitors Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors

Paragraph IV (Patent) Challenges for ISTURISA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ISTURISA	Tablets	osilodrostat phosphate	1 mg and 5 mg	212801	1	2026-08-17

US Patents and Regulatory Information for ISTURISA

ISTURISA is protected by nine US patents and two FDA Regulatory Exclusivities.

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
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No			Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	Yes				Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No			Y	Y

Expired US Patents for ISTURISA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020

International Patents for ISTURISA

When does loss-of-exclusivity occur for ISTURISA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

Peru

Philippines

Poland

Portugal

Singapore

Slovenia

South Korea

Spain

Taiwan

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ISTURISA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	101116
Australia	2015287336
Brazil	112016030243
Canada	2954393
Chile	2017000026
China	106470704
Cyprus	1120749

Supplementary Protection Certificates for ISTURISA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2523731	301043	Netherlands		PRODUCT NAME: OSILODROSTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, MET INBEGRIP VAN OSILODROSTATDIWATERSTOFFOSFAAT; REGISTRATION NO/DATE: EU/1/19/1407 20200113
2523731	CA 2020 00025	Denmark		PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113
2523731	132020000000052	Italy		PRODUCT NAME: OSILODROSTAT(ISTURISA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1407, 20200113
2523731	122020000026	Germany		PRODUCT NAME: OSILODROSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH OSILODROSTATDIHYDROGENPHOSPHAT; REGISTRATION NO/DATE: EU/1/19/1407 20200109
2523731	LUC00159	Luxembourg		PRODUCT NAME: OSILODROSTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, Y COMPRIS LE DIHYDROGENOPHOSPHATE D'OSILODROSTAT; AUTHORISATION NUMBER AND DATE: EU/1/19/1407 20200113
2523731	PA2020512	Lithuania		PRODUCT NAME: OSILODROSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, ISKAITANT OSILODROSTATO DIHIDROFOSFATA; REGISTRATION NO/DATE: EU/1/19/1407 20200109
2523731	2020C/520	Belgium		PRODUCT NAME: OSILODROSTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN, INCLUSIEF OSILODROSTAT DIWATERSTOFFOSFAAT; AUTHORISATION NUMBER AND DATE: EU/1/19/1407 20200113

Isturisa Market Dynamics, Revenue Outlook, Patent Protection and Competitive Position

Last updated: October 29, 2026

Isturisa, the brand name for osilodrostat, is a targeted treatment for endogenous Cushing's syndrome, including Cushing's disease. Recordati commercializes the drug globally after acquiring worldwide rights from Novartis in 2019. Its market trajectory depends on diagnosis rates, endocrinology adoption, reimbursement, treatment sequencing and competition from surgery, steroidogenesis inhibitors and pituitary-directed therapies.

Recordati's acquisition transformed Isturisa from a pre-commercial Novartis asset into a growth product within Recordati's rare-disease portfolio. The drug has regulatory approval in the United States, European Union and other markets. Its commercial opportunity is limited by the small patient population but supported by chronic treatment, high unmet need and orphan-drug pricing.

What is Isturisa and how does osilodrostat work?

Isturisa contains osilodrostat, an oral steroidogenesis inhibitor that blocks 11-beta-hydroxylase, also known as CYP11B1. This reduces cortisol production in patients with endogenous hypercortisolism.

Attribute	Isturisa
Active ingredient	Osilodrostat
Primary indication	Endogenous hypercortisolism, including Cushing's disease
Dosage form	Oral tablets
Initial U.S. approval	March 6, 2020
U.S. sponsor	Recordati Rare Diseases Inc.
Global commercial rights	Recordati
Treatment setting	Chronic endocrine disease management
Main prescribers	Endocrinologists and specialized pituitary centers

The FDA approved Isturisa for adults who cannot undergo pituitary surgery or who have persistent or recurrent disease after surgery. The European Commission authorized Isturisa in 2020 for endogenous Cushing's syndrome in adults.

Osilodrostat differs from pituitary-directed agents because it directly suppresses cortisol synthesis. That mechanism creates a role for patients requiring rapid biochemical control or those who are not surgical candidates.

How large is the Isturisa and Cushing's disease market?

The addressable market is small in patient volume but commercially attractive because Cushing's disease requires specialist care and long-term management.

Cushing's syndrome has an estimated annual incidence of roughly 1.2 to 2.4 cases per million people, with Cushing's disease representing the majority of endogenous cases in many epidemiologic studies. The actual treated population is larger than incidence figures because patients may remain on therapy for several years and may cycle through multiple treatments.

The principal market-expansion constraints are:

• underdiagnosis and delayed diagnosis;
• limited access to pituitary surgery and endocrine specialists;
• reimbursement restrictions for rare-disease medicines;
• treatment discontinuation after surgery or radiotherapy;
• adverse-event monitoring requirements;
• competition from established off-label therapies.

The commercial market is concentrated in the United States, major European markets and Japan. Specialist distribution and reimbursement support are more important than broad primary-care promotion.

What drives demand for Isturisa?

Demand is driven by five factors:

1. Patients with persistent or recurrent Cushing's disease after surgery.
2. Patients who are not surgical candidates.
3. Patients requiring pharmacologic control while awaiting surgery or radiotherapy.
4. Patients who fail or cannot tolerate ketoconazole, metyrapone, pasireotide or mifepristone.
5. Patients requiring a titratable oral therapy with direct cortisol-lowering activity.

Isturisa's twice-daily oral administration supports chronic use. Its principal clinical limitation is the need to monitor adrenal insufficiency, QT prolongation, hypokalemia and other consequences of excessive cortisol suppression.

What is Recordati's financial trajectory from Isturisa?

Recordati does not consistently disclose Isturisa as a fully separate line item in every public financial communication. The company reports the drug within its portfolio of specialty and rare-disease products, which limits precise external reconstruction of product-level revenue.

The financial trajectory has nevertheless been favorable because Isturisa entered the market after Recordati's acquisition and has benefited from geographic expansion and increasing endocrinologist awareness.

Period	Commercial position	Financial implication
2019	Recordati acquired global rights from Novartis	Upfront and development-commercialization investment created a long-term rare-disease asset
2020	U.S. and European regulatory approvals	Initial launch expenses and limited early-market penetration
2021	Early commercial rollout	Reimbursement and specialist adoption became key constraints
2022-2023	Broader international availability	Product contribution increased as treatment centers gained experience
2024 onward	Portfolio maturation	Growth depends more on patient identification, persistence and geographic execution

Recordati's total revenue reached approximately €2.1 billion in 2023, reflecting the company's broader portfolio rather than Isturisa alone (Recordati, 2024). Isturisa is strategically important because it is a specialty product with orphan-disease economics, but it is not the company's largest revenue generator.

How does Isturisa affect Recordati's earnings?

Isturisa has several favorable economic characteristics:

• specialty prescribing limits selling costs;
• chronic use can produce recurring revenue;
• orphan-disease pricing supports high revenue per treated patient;
• the product is differentiated by a direct steroidogenesis mechanism;
• the drug complements Recordati's rare-disease and specialty-care strategy.

The main earnings risks are slower diagnosis, payer step edits, treatment discontinuation and greater use of lower-cost generic steroidogenesis inhibitors. Recordati also faces the normal launch-to-maturity transition, in which revenue growth slows after the principal specialist centers have adopted the product.

How does Isturisa compare with competing Cushing's syndrome drugs?

Isturisa competes with surgery, off-label medicines and approved endocrine products rather than with a single direct substitute.

Therapy	Company or source	Mechanism	Commercial position
Isturisa	Recordati	11-beta-hydroxylase inhibition	Oral steroidogenesis inhibitor for chronic control
Signifor	Novartis	Somatostatin receptor agonism	Pituitary-directed therapy
Korlym	Corcept Therapeutics	Glucocorticoid receptor antagonism	Approved for hyperglycemia associated with Cushing's syndrome
Recorlev	Xeris Biopharma	Ketoconazole formulation	Oral cortisol synthesis inhibitor
Metyrapone	Multiple manufacturers	11-beta-hydroxylase inhibition	Established and often used off label or under national approvals
Ketoconazole	Generic manufacturers	Multiple steroidogenesis effects	Lower-cost generic alternative
Pituitary surgery	Specialist centers	Tumor removal	First-line treatment for many patients with Cushing's disease

Isturisa's strongest competitive attributes are potency, direct cortisol synthesis inhibition and oral administration. Its disadvantages include laboratory monitoring, risk of adrenal insufficiency and competition from inexpensive generic therapies.

Recorlev is the closest branded pharmacologic competitor because it also inhibits cortisol synthesis. Korlym competes for patients whose principal clinical problem is hyperglycemia rather than biochemical cortisol normalization.

When does Isturisa lose exclusivity?

Isturisa's exclusivity profile has several layers:

Protection	Timing or status
U.S. orphan-drug exclusivity	Generally seven years from FDA approval, subject to statutory limitations
U.S. new chemical entity exclusivity	Generally five years from approval if applicable
European orphan exclusivity	Generally ten years from European authorization, subject to review and possible extension
Patent protection	Depends on the issued claims, listed patents and applicable patent-term adjustments
Data exclusivity	Varies by jurisdiction and regulatory pathway

The FDA approved Isturisa on March 6, 2020. If orphan exclusivity applies from that approval date, the principal U.S. orphan period would run into 2027. Orphan exclusivity blocks approval of the same drug for the same indication, but it does not prevent all competing treatments or every possible generic strategy.

European orphan exclusivity generally extends ten years from the relevant marketing authorization, potentially placing the core period around 2030. The duration can be affected by regulatory review and pediatric incentives.

Patent expiry cannot be determined from regulatory exclusivity alone. A generic applicant could face listed composition, formulation, method-of-use or manufacturing patents after a regulatory exclusivity period ends.

What patents protect Isturisa?

Isturisa protection is expected to rely on a combination of:

• patents covering osilodrostat or related substituted heterocyclic compounds;
• pharmaceutical composition claims;
• dosage and titration methods;
• methods for treating endogenous hypercortisolism;
• solid-state or salt forms, if separately claimed;
• manufacturing processes and intermediates.

Patent protection is more commercially important than orphan exclusivity because a valid, enforceable patent can delay generic launch beyond the orphan period. Method-of-use patents may be particularly relevant because the approved indication is narrow and specialist-defined.

Public regulatory data should be read together with the FDA Orange Book and the relevant national patent registers. Patent term adjustment, patent-term extension, terminal disclaimers and claim scope determine the effective barrier. A patent's nominal expiration date does not establish that all claims will survive litigation or that a generic applicant cannot launch under a section viii strategy.

What is the Orange Book status of Isturisa?

Isturisa is an FDA-approved prescription drug listed under NDA 214736. Orange Book-listed patents, if present, are the principal patents that an ANDA applicant must address through a Paragraph IV certification or, where appropriate, a section viii statement.

The commercial consequences are:

• a Paragraph IV certification can trigger patent litigation;
• litigation can produce a 30-month stay of ANDA approval under applicable law;
• a successful Paragraph IV challenge can accelerate generic entry;
• a section viii strategy may permit approval for non-patented uses while excluding protected indications;
• orphan exclusivity may independently prevent approval for the protected orphan indication.

No widely reported U.S. Paragraph IV litigation involving an osilodrostat generic had materially changed the commercial outlook through the publicly available record used for this analysis. The absence of reported litigation does not eliminate future challenge risk.

Which companies are challenging Isturisa?

No major publicly reported generic challenger has established a visible commercial position against Isturisa. Potential challengers would most likely include:

• large generic manufacturers with endocrine portfolios;
• specialty generic companies;
• manufacturers capable of developing complex small-molecule formulations;
• companies pursuing an abbreviated new drug application after relevant exclusivity periods.

The near-term challenge risk is lower than for a high-volume primary-care drug because the market is small and clinical monitoring is specialized. The risk increases if Isturisa revenue reaches a level that supports the cost of Paragraph IV litigation and commercial launch.

What formulation and manufacturing barriers protect Isturisa?

Osilodrostat is an oral small molecule, so it does not have the manufacturing complexity associated with biologics, sterile injectables or long-acting depot systems. The technical barrier is therefore moderate rather than high.

Potential barriers include:

• control of impurities and related steroidogenic compounds;
• reproducible tablet manufacture across multiple strengths;
• bioequivalence across dose levels;
• stability and dissolution requirements;
• supply of specialized intermediates;
• regulatory validation of manufacturing sites;
• clinical and pharmacodynamic interpretation of bioequivalence.

These barriers may delay a generic launch, but they are unlikely to create the same durable protection as a biologic manufacturing platform.

What litigation and settlement agreements affect Isturisa?

No major public patent settlement involving an Isturisa generic challenger was identified in the relevant public record. The litigation risk remains concentrated in future ANDA filings and in disputes over composition, method-of-use and formulation claims.

If a Paragraph IV case arises, the most important commercial questions will be:

1. whether the challenged patent is Orange Book listed;
2. whether the patent covers the approved indication or only a narrower use;
3. whether Recordati receives a 30-month stay;
4. whether the generic applicant can launch with a label carve-out;
5. whether a settlement permits an authorized generic or an agreed entry date.

What generic launch scenarios exist for Isturisa?

Early launch after a successful Paragraph IV challenge

A generic could launch before all listed patents expire if it invalidates or avoids the relevant claims. This would create the greatest price and volume pressure.

Entry after orphan exclusivity expires

A generic may still face patents after the orphan period ends. Orphan expiry therefore does not automatically create immediate generic competition.

Carve-out launch

A generic applicant could seek approval for uses outside a protected method-of-use claim. This strategy would reduce the initial commercial impact but could still affect prescribing if physicians use the generic broadly.

Authorized generic or settlement launch

Recordati could pursue a settlement or authorized-generic arrangement that controls the timing and economics of entry. No material public settlement of this type was identified for Isturisa.

How strong is the Isturisa patent estate?

The estate appears commercially meaningful but not structurally impenetrable.

Factor	Assessment
Product type	Small molecule, which is generally more vulnerable to generic development than biologics
Orphan status	Strong regulatory protection for the approved rare-disease indication
Clinical differentiation	Meaningful, based on direct cortisol synthesis inhibition
Manufacturing complexity	Moderate
Patient population	Small, reducing generic incentive
Chronic treatment	Supports recurring branded revenue
Patent vulnerability	Depends on claim breadth and Orange Book listing
Litigation exposure	Manageable today, but likely to rise as revenue matures

The strongest protection is likely the combination of orphan economics, specialist prescribing and patent-backed indication protection. The weakest element is the absence of biologic or device-level manufacturing complexity.

What is the FDA regulatory status of Isturisa?

Isturisa is FDA approved for adults with endogenous hypercortisolism who cannot undergo pituitary surgery or who have persistent or recurrent disease after surgery. The FDA label includes dosing escalation and monitoring for hypocortisolism, QT prolongation, hypokalemia and related safety risks (U.S. Food and Drug Administration, 2020).

The drug's regulatory status supports chronic use but also creates a monitoring burden. Safety management is central to reimbursement and treatment persistence because endocrinologists must titrate cortisol reduction without causing adrenal insufficiency.

What is the commercial outlook for Isturisa?

The base-case outlook is steady specialty growth rather than mass-market expansion. Revenue should be supported by:

• increased diagnosis of Cushing's disease;
• wider access to endocrine centers;
• continued international launches;
• use after failed surgery;
• chronic treatment duration;
• expansion of Recordati's rare-disease infrastructure.

The principal downside risks are:

• increased generic use of ketoconazole and metyrapone;
• competition from Recorlev and Signifor;
• payer restrictions;
• adverse-event-driven discontinuation;
• patent or label challenges;
• limited disease prevalence.

Isturisa is unlikely to become a blockbuster in the conventional large-population sense. Its value lies in high revenue per patient, durable specialist demand and portfolio fit with Recordati's rare-disease strategy.

Key Takeaways

• Isturisa is Recordati's oral osilodrostat product for endogenous Cushing's syndrome and Cushing's disease.
• FDA approval occurred on March 6, 2020; European authorization followed in 2020.
• Commercial growth depends on diagnosis, specialist adoption, reimbursement and chronic treatment persistence.
• The principal competitors are Signifor, Korlym, Recorlev, metyrapone, ketoconazole and pituitary surgery.
• U.S. orphan exclusivity would generally extend into 2027, while European orphan protection would generally extend around 2030, subject to applicable rules.
• Patent protection may extend beyond regulatory exclusivity, but the exact generic-entry date depends on Orange Book listings, patent claims and litigation.
• No major public Paragraph IV challenge or settlement had materially altered Isturisa's commercial position in the reviewed record.
• The product has a moderate patent and manufacturing barrier, with stronger protection from specialist economics and orphan status than from complex manufacturing.
• Isturisa is a strategically valuable specialty asset for Recordati, but its financial contribution remains smaller than the company's major portfolio products.

FAQs About Isturisa Market Exclusivity and Revenue

Is Isturisa a blockbuster drug?

No. Isturisa is a high-value orphan specialty product, but the limited prevalence of Cushing's disease restricts the total addressable patient population.

Who owns Isturisa?

Recordati owns the global commercial rights acquired from Novartis in 2019. Recordati markets the product through its specialty and rare-disease operations.

Can a generic version of Isturisa launch after 2027?

Possibly, but not automatically. A generic applicant would need to address remaining patents, regulatory exclusivity, FDA approval requirements and any litigation-related stay.

Is Isturisa better than Recorlev?

Neither drug is universally superior. Both inhibit cortisol synthesis, but selection depends on prior therapy, liver risk, dosing, tolerability, monitoring and physician preference.

Does Isturisa require lifelong treatment?

Not necessarily. Treatment duration depends on surgery, radiotherapy, disease recurrence, biochemical response and tolerability. Some patients use Isturisa chronically, while others use it as bridging or adjunctive therapy.

References

1. Recordati S.p.A. (2024). Annual report 2023. Milan, Italy: Recordati S.p.A.

2. U.S. Food and Drug Administration. (2020). Isturisa (osilodrostat) prescribing information. Silver Spring, MD: U.S. Department of Health and Human Services.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. Silver Spring, MD: U.S. Department of Health and Human Services.

4. European Medicines Agency. (2020). Isturisa: EPAR - product information. Amsterdam, Netherlands: European Medicines Agency.

5. Fleseriu, M., Auchus, R., Bancos, I., Ben-Shlomo, A., Biermasz, N. R., Boguszewski, C. L., et al. (2021). Consensus on diagnosis and management of Cushing's disease: A guideline update. The Lancet Diabetes & Endocrinology, 9(12), 847-875.

6. Pivonello, R., De Leo, M., Cozzolino, A., & Colao, A. (2015). The treatment of Cushing's disease. Endocrine Reviews, 36(4), 385-486.