Recordati Rare Company Profile

What is the competitive landscape for RECORDATI RARE, and what generic alternatives to RECORDATI RARE drugs are available?

RECORDATI RARE has twelve approved drugs.

There are eleven US patents protecting RECORDATI RARE drugs.

There are two hundred and eighty-three patent family members on RECORDATI RARE drugs in sixty countries and fifty-one supplementary protection certificates in nineteen countries.

Summary for Recordati Rare

International Patents:	283
US Patents:	11
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	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012		RX	Yes	No	8,299,209		Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No	8,835,646		Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No	8,835,646		Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No

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	203255-002	Dec 15, 2014	6,225,284
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	6,342,530
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012	6,225,284
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014	6,225,284
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	6,344,479
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012	6,225,284

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
Tunisia	SN08082
Poland	1648934
Ukraine	96737
Russian Federation	2006120484
South Korea	20170029491
Norway	340854

Supplementary Protection Certificates for Recordati Rare Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2523731	CR 2020 00025	Denmark		PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113
1919458	2014C/018	Belgium		PRODUCT NAME: CYSTEAMINE; AUTHORISATION NUMBER AND DATE: EU/1/13/861 20130910
2523731	SPC/GB20/034	United Kingdom		PRODUCT NAME: OSILODROSTAT, OR OSILODROSTAT PHOSPHATE; REGISTERED: UK EU/1/19/1407/001(NI) 20200113; UK EU/1/19/1407/002(NI) 20200113; UK EU/1/19/1407/003(NI) 20200113; UK PLGB 15266/0029-0001 20200113; UK PLGB 15266/0030-0001 20200113; UK PLGB 15266/0031-0001 20200113
2523731	24/2020	Austria		PRODUCT NAME: OSILODROSTAT ODER PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH OSILODROSTATDIHYDROGENPHOSPHAT; REGISTRATION NO/DATE: EU/1/19/1407 (MITTEILUNG) 20200113
2523731	20C1023	France		PRODUCT NAME: OSILODROSTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, Y COMPRIS LE DIHYDROGENOPHOSPHATE D'OSILODROSTAT; REGISTRATION NO/DATE: EU/1/19/1407 20200113
2523731	2090024-7	Sweden		PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE; REG. NO/DATE: EU/1/19/1407 20200113

Similar Applicant Names

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

• Recordati Rare