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-two 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:	282
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	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012		RX	Yes	No	8,299,209		Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012		RX	Yes	No	8,299,209		Y	Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-004	Jun 29, 2018		RX	Yes	No	7,759,308		Y
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	203255-001	Dec 15, 2014		RX	Yes	No	7,473,761		Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No	9,434,754			Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No	10,709,691

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	8,822,637
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	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	6,342,530
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	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	200677-003	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
South Korea	20170029491
Mexico	2016017315
Germany	60133823
Brazil	112016030243
Taiwan	200529883
South Korea	20120116482
Cyprus	1108547

Supplementary Protection Certificates for Recordati Rare Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1919458	2014C/018	Belgium		PRODUCT NAME: CYSTEAMINE; AUTHORISATION NUMBER AND DATE: EU/1/13/861 20130910
1686964	C 2015 008	Romania		PRODUCT NAME: PASIREOTIDA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIASAU ORICE HIDRAT AL ACESTEIACICLO[(4R)-4-(2-AMINOETILCARBAMOILOXI)-L-PROLIL-L-FENILGLICIL-D-TRIPTOFIL-L-LISIL-4-O-BENZIL-L-TIROSIL-L-FENILALANIL-); NATIONAL AUTHORISATION NUMBER: EU/1/12/753/013, EU/1/12/753/014, EU/1/12/753/015, EU/1/12/753/016, EU/1/12/753/017; DATE OF NATIONAL AUTHORISATION: 20141119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/753/013, EU/1/12/753/014, EU/1/12/753/015, EU/1/12/753/016, EU/1/12/753/017; DATE OF FIRST AUTHORISATION IN EEA: 20141119
1648934	PA2012016,C1648934	Lithuania		PRODUCT NAME: PASIREOTIDUM; REGISTRATION NO/DATE: EU/1/12/753/001 - EU/1/12/753/012, 0120424
1307486	1290022-1	Sweden		PRODUCT NAME: PASIREOTID; REG. NO/DATE: EU/1/12/753/001 20120424
2523731	C20200013 00309	Estonia		PRODUCT NAME: OSILODROSTAAT;REG NO/DATE: EU/1/19/1407 13.01.2020
1686964	C01686964/01	Switzerland		PRODUCT NAME: PASIREOTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65148 25.02.2015
1686964	CR 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, C(2014)8916 20141121

Similar Applicant Names

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

• Recordati Rare