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.

Summary for Recordati Rare

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	212801-001	Mar 6, 2020		RX	Yes	No	8,609,862
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	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014		RX	Yes	No	9,351,923		Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No
Recordati Rare	COSMEGEN	dactinomycin	INJECTABLE;INJECTION	050682-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

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	6,344,479
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012	8,299,209
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014	6,225,284
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012	8,299,209
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012	8,299,209
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
Iceland	8480
Australia	2006283105
Peru	20090387
Japan	2018150326
Japan	6425688
Mexico	2008002545

Supplementary Protection Certificates for Recordati Rare Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	132012902062571	Italy		PRODUCT NAME: PASIREOTIDE DIASPARTATO(SIGNIFOR); AUTHORISATION NUMBER(S) AND DATE(S): EU71/12/753/001-012, 20120424
2523731	122020000026	Germany		PRODUCT NAME: OSILODROSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH OSILODROSTATDIHYDROGENPHOSPHAT; REGISTRATION NO/DATE: EU/1/19/1407 20200109
2523731	202040016	Slovenia		PRODUCT NAME: OSILODROSTAT OR ITS PHARMACEUTICALLY ACCEPTABLE SALT INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1407; DATE OF NATIONAL AUTHORISATION: 20200109; AUTHORITY FOR NATIONAL AUTHORISATION: EU
1686964	CA 2015 00026	Denmark		PRODUCT NAME: PASIREOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET HVILKET SOM HELST HYDRAT DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753 20141119
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
1686964	300716	Netherlands		PRODUCT NAME: PASIREOTIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/753 20141119

Similar Applicant Names

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

• Recordati Rare