Shilpa Company Profile

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SHILPA has fourteen approved drugs.

There are five US patents protecting SHILPA drugs. There are two tentative approvals on SHILPA drugs.

There are fifty-four patent family members on SHILPA drugs in twenty-six countries and fifty supplementary protection certificates in sixteen countries.

International Patents:	54
US Patents:	5
Tradenames:	12
Ingredients:	12
NDAs:	14
Patent Litigation for Shilpa:	See patent lawsuits for Shilpa

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shilpa	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	208513-001	May 15, 2019		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Shilpa	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	208718-003	Aug 16, 2019	AP	RX	No	No		⤷ Sign Up				⤷ Sign Up
Shilpa	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	211960-002	Nov 5, 2019	AB	RX	No	No		⤷ Sign Up				⤷ Sign Up
Shilpa	APREMILAST	apremilast	TABLET;ORAL	211774-001	Apr 7, 2023	AB	RX	No	No		⤷ Sign Up				⤷ Sign Up
Shilpa	PEMETREXED	pemetrexed disodium	SOLUTION;INTRAVENOUS	215179-003	May 22, 2023		RX	Yes	Yes	11,147,817	⤷ Sign Up	Y			⤷ Sign Up
Shilpa	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	205934-001	Dec 22, 2015	AP	RX	Yes	Yes	10,842,770	⤷ Sign Up	Y			⤷ Sign Up
Shilpa	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	210327-001	May 16, 2019	AP	RX	No	No		⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	201201453	⤷ Sign Up
European Patent Office	2903435	⤷ Sign Up
South Korea	20150066542	⤷ Sign Up
Eurasian Patent Organization	027666	⤷ Sign Up
Hong Kong	1259184	⤷ Sign Up
China	102970990	⤷ Sign Up
Colombia	6640232	⤷ Sign Up
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0316704	SPC/GB01/015	United Kingdom	⤷ Sign Up	PRODUCT NAME: CAPECITABINE AND HYDRATES AND SOLVATES THEREOF; REGISTERED: CH 54657 19980610; UK EU/1/00/163/001-002 20010202
2962690	C 2019 032	Romania	⤷ Sign Up	PRODUCT NAME: APREMILAST SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115
1746976	17C1027	France	⤷ Sign Up	PRODUCT NAME: SEL DE SUCROSOFATE D'IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
0275821	01C0035	France	⤷ Sign Up	PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
1746976	C01746976/01	Switzerland	⤷ Sign Up	PRODUCT NAME: IRINOTECAN SUCROSOFAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65994 25.07.2017
2962690	365 14-2019	Slovakia	⤷ Sign Up	PRODUCT NAME: APREMILAST VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/981 20150116
0122707	96C0030	Belgium	⤷ Sign Up	PRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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