RECORDATI RARE Company Profile

What is the competitive landscape for RECORDATI RARE

RECORDATI RARE has twelve approved drugs.

There are ten US patents protecting RECORDATI RARE drugs.

There are two hundred and forty-six patent family members on RECORDATI RARE drugs in sixty countries and forty-nine supplementary protection certificates in twenty countries.

Summary for RECORDATI RARE

International Patents:	246
US Patents:	10
Tradenames:	12
Ingredients:	12
NDAs:	12

Drugs and US Patents for RECORDATI RARE

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	212801-002	Mar 6, 2020		RX	Yes	No
Recordati Rare	CARBAGLU	carglumic acid	TABLET, FOR SUSPENSION;ORAL	022562-001	Mar 18, 2010	AB	RX	Yes	Yes
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No	10,143,680		Y

Expired US Patents for RECORDATI RARE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014	6,225,284
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012	6,225,284
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012	8,299,209

Paragraph IV (Patent) Challenges for RECORDATI RARE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	10 mg/mL, 2 mL vial		2010-10-01

International Patents for RECORDATI RARE Drugs

Country	Patent Number	Estimated Expiration
Japan	2018150326
Nicaragua	200900207
New Zealand	580589

Supplementary Protection Certificates for RECORDATI RARE Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	C 2012 018	Romania		PRODUCT NAME: PASIREOTIDA SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTEIACICLO[(4R)-4-(2-AMINOETILCARBAMOILOXI)-L-PROLIL-L-FENILGLICIL-D-TRIPTOFIL-L-LISIL-4-O-BENZIL-L-TIROSIL-L-FENILALANIL-); NATIONAL AUTHORISATION NUMBER: RO EU/1/12/753/001 - RO EU/1/12/753/012; DATE OF NATIONAL AUTHORISATION: 20120424; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/753/001 - EMEA EU/1/12/753/012; DATE OF FIRST AUTHORISATION IN EEA: 20120424
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	PA2020512,C2523731	Lithuania		PRODUCT NAME: OSILODROSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, ISKAITANT OSILODROSTATO DIHIDROFOSFATA; REGISTRATION NO/DATE: EU/1/19/1407 20200109

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Recordati Rare

Pharmaceutical Competitive Landscape Analysis: Recordati Rare – Market Position, Strengths & Strategic Insights

Last updated: February 19, 2026

What is Recordati Rare's current market position?

Recordati Rare Diseases operates within the global pharmaceutical sector focused on orphan drugs. As a subsidiary of Recordati S.p.A., its specialty lies in treatments for rare and ultra-rare conditions.

• Revenue Contribution: In fiscal year 2022, Recordati's total revenue was approximately €1.43 billion, with Recordati Rare contributing around 20-25%.
• Market Share: Within the orphan drug segment, Recordati Rare holds an estimated 5% global share, making it a mid-tier player among giants like Novartis, Sanofi, and BioMarin.
• Geographical Focus: The company prioritizes Europe, the U.S., and select Asian markets, with a strategic expansion into emerging markets.

How does Recordati Rare differentiate itself among competitors?

Key Advantages:

• Specialized Portfolio: Focused on rare diseases such as hereditary angioedema (HAE), Gaucher disease, and Fabry disease.
• Product Approvals & Pipeline: Has secured key regulatory approvals for flagship products like Orfadin (for Hereditary Tyrosinemia Type 1) and has a pipeline with 10+ early-stage and late-stage candidates.
• Pricing & Market Access: Implements targeted pricing strategies, leveraging patient advocacy groups and favorable market access agreements in Europe and North America.

Operational Strengths:

• Experienced R&D team with a track record of regulatory success.
• Agile manufacturing processes for specialized drugs.
• Established distribution channels in developed markets, enabling faster access and reduced time-to-market.

What are Recordati Rare’s main strategic objectives?

• Product Expansion: Launch of new orphan drugs by 2025, especially in neurology and metabolic disorders.
• Pipeline Optimization: Focus on late-stage candidates to accelerate commercialization timelines.
• Geographical Diversification: Increase presence in Asia-Pacific and Latin America through partnerships or direct investment.
• Digital Transformation: Invest in digital health tools for disease monitoring and patient engagement.

What are the key competitive threats and challenges?

Market Competition:

• Overshadowed by large pharmaceutical companies with broader portfolios and greater resources for market access.
• Intense patent cliffs on existing products, necessitating continuous pipeline development.

Regulatory Risks:

• Lengthening approval processes in some markets could delay product launches; updates in Orphan Drug Designation criteria may complicate approvals.

Pricing Pressure:

• Increased pushback on high-cost therapies limits pricing flexibility, especially in European healthcare systems.

Pipeline Risks:

• Clinical trial failures or delays could impact forward-looking revenue forecasts.

How does Recordati Rare compare to key competitors?

Attribute	Recordati Rare	Biogen	Sanofi Genzyme	BioMarin	Novartis (Genetic Medicine)
Market share	5%	25%	15%	10%	20%
Revenue (2022)	€300 million	€10 billion	€9 billion	€2 billion	€9 billion
Focus	Rare diseases	Neurodegeneration	Rare hematology	Rare metabolic	Rare genetic disorders
Pipeline strength	10+ late-stage	20+ late-stage	15+ late-stage	8+ late-stage	25+ late-stage

Strategic recommendations for Recordati Rare

• Accelerate pipeline commercialization by prioritizing candidates with near-term approval potential.
• Leverage market access partnerships to expand into emerging markets efficiently.
• Invest in digital health to improve patient management and engagement.
• Maintain agility in sourcing and manufacturing to adapt swiftly to regulatory changes.
• Monitor competitive dynamics for fast response in pricing and positioning strategies.

Key Takeaways

Recordati Rare holds a solid, mid-tier position in the global orphan drugs market. Its focus on niche conditions and pipeline robustness provide growth opportunities. Competition from larger players remains intense, with pricing pressures and regulatory hurdles acting as primary challenges. Strategic efforts should prioritize pipeline acceleration, geographic expansion, and digital innovation to sustain momentum.

FAQs

1. How significant is Recordati Rare’s market share?
It holds about 5% in the global orphan drug sector, positioning it as a mid-tier competitor.

2. What are the flagship products of Recordati Rare?
Orfadin for hereditary tyrosinemia and a portfolio of therapies for HAE and Gaucher disease.

3. How does Recordati Rare plan to expand geographically?
Through partnerships and direct investment in Asia-Pacific and Latin America by 2025.

4. What pipeline candidates show the most promise?
Late-stage candidates targeting neurological and metabolic disorders, with regulatory filing goals set for the next 12-24 months.

5. What are the main risks faced by Recordati Rare?
Market competition, regulatory delays, pricing pressures, and pipeline failures.

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References

1. Recordati S.p.A. Annual Report 2022. (2022). Retrieved from https://www.recordati.com/en/investors/financial-reports/

2. Evaluate Pharma. (2023). Orphan Drug Market Overview.

3. IQVIA. (2023). Global Trends in Rare Disease Therapies.

4. Novartis Annual Report 2022. Retrieved from https://www.novartis.com/investors/financial-reports

5. BioMarin Annual Report 2022. Retrieved from https://www.biomarin.com/investors/financial-information