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	8,609,862
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-005	Jun 29, 2018		RX	Yes	No	9,351,923		Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014		RX	Yes	Yes
Recordati Rare	COSMEGEN	dactinomycin	INJECTABLE;INJECTION	050682-001	Approved Prior to Jan 1, 1982		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	212801-002	Mar 6, 2020		RX	Yes	No
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	AP	RX	Yes	Yes	8,415,337		Y	Y

Expired US Patents for Recordati Rare

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	6,342,530
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	6,344,479
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014	6,225,284
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014	8,822,637
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014	6,225,284
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

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
Montenegro	00955
Iceland	8247
Peru	20050581
Germany	602004022420
Australia	2006283105
Spain	2761227
Denmark	3166596

Supplementary Protection Certificates for Recordati Rare Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2523731	C202030030	Spain		PRODUCT NAME: OSILODROSTAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, INCLUIDO EL OSILODROSTAT DIHIDROGENO FOSFATO.; NATIONAL AUTHORISATION NUMBER: EU/1/19/1407; DATE OF AUTHORISATION: 20200109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1407; DATE OF FIRST AUTHORISATION IN EEA: 20200109
1307486	C01307486/01	Switzerland		PRODUCT NAME: PASIREOTID; REGISTRATION NO/DATE: SWISSMEDIC 61254 02.11.2012
1919458	300649	Netherlands		PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
1307486	122012000045	Germany		PRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON ODER EIN KOMPLEX HIERVON; REGISTRATION NO/DATE: EU/1/12/753/001-012 20120424
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
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
1686964	122015000015	Germany		PRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER JEGLICHES HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/12/753/013-017 20141119

Similar Applicant Names

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

• Recordati Rare