Pasireotide diaspartate - Generic Drug Details
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What are the generic sources for pasireotide diaspartate and what is the scope of freedom to operate?
Pasireotide diaspartate
is the generic ingredient in one branded drug marketed by Recordati Rare and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Pasireotide diaspartate has eighty-seven patent family members in thirty-nine countries.
One supplier is listed for this compound.
Summary for pasireotide diaspartate
International Patents: | 87 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 47 |
Patent Applications: | 1,793 |
DailyMed Link: | pasireotide diaspartate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for pasireotide diaspartate
Generic Entry Date for pasireotide diaspartate*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for pasireotide diaspartate
Drug Class | Somatostatin Analog |
Mechanism of Action | Somatostatin Receptor Agonists |
US Patents and Regulatory Information for pasireotide diaspartate
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 | 200677-003 | Dec 14, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-002 | Dec 14, 2012 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-001 | Dec 14, 2012 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-003 | Dec 14, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-002 | Dec 14, 2012 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-001 | Dec 14, 2012 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for pasireotide diaspartate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-001 | Dec 14, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-003 | Dec 14, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-002 | Dec 14, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for pasireotide diaspartate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2006101720 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ | ⤷ Try a Trial |
South Korea | 100799394 | ⤷ Try a Trial | |
Japan | 2007536195 | ⤷ Try a Trial | |
Israel | 153920 | SOMATOSTATIN ANALOGUES, PROCESSES FOR THEIR PRODUCTION, PHARMACEUTICAL COMPOSITIONS COMPRISING THEM AND USE THEREOF IN THE PREPARATION OF MEDICAMENTS FOR THERAPY | ⤷ Try a Trial |
Portugal | 1648934 | ⤷ Try a Trial | |
Croatia | P20090571 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for pasireotide diaspartate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1307486 | C 2012 018 | Romania | ⤷ Try a Trial | 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 |
1307486 | CA 2012 00024 | Denmark | ⤷ Try a Trial | |
1307486 | 132012902062571 | Italy | ⤷ Try a Trial | PRODUCT NAME: PASIREOTIDE DIASPARTATO(SIGNIFOR); AUTHORISATION NUMBER(S) AND DATE(S): EU71/12/753/001-012, 20120424 |
1648934 | PA2012016,C1648934 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PASIREOTIDUM; REGISTRATION NO/DATE: EU/1/12/753/001 - EU/1/12/753/012, 0120424 |
1648934 | C20120019 00062 | Estonia | ⤷ Try a Trial | PRODUCT NAME: SIGNIFOR-PASIREOTIID;REG NO/DATE: C(2012) 2910 FINAL 24.04.2012 |
1307486 | 12C0041 | France | ⤷ Try a Trial | PRODUCT NAME: CYCLO((4R)-4(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-) : PASIREOTIDE, OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/753/001 20120424 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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