Shilpa Company Profile

What is the competitive landscape for SHILPA, and when can generic versions of SHILPA drugs launch?

SHILPA has fourteen approved drugs.

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

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

Summary for Shilpa

International Patents:	55
US Patents:	5
Tradenames:	12
Ingredients:	12
NDAs:	14
Patent Litigation for Shilpa:	See patent lawsuits for Shilpa

Drugs and US Patents for Shilpa

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shilpa	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	205934-002	Dec 22, 2015	AP	RX	Yes	Yes	8,940,786		Y
Shilpa	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	205934-001	Dec 22, 2015	AP	RX	Yes	Yes	9,308,195		Y
Shilpa	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	211960-002	Nov 5, 2019	AB	RX	No	No
Shilpa	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	208302-001	Jan 17, 2019	AB	RX	No	No
Shilpa	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	205934-003	Dec 22, 2015	AP	RX	Yes	Yes	8,940,786		Y
Shilpa	BUSULFAN	busulfan	INJECTABLE;INJECTION	210931-001	Apr 18, 2019	AP	RX	No	No
Shilpa	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	208718-002	Dec 28, 2018	AP	RX	No	No

International Patents for Shilpa Drugs

Country	Patent Number	Estimated Expiration
Mexico	2012012630
Taiwan	I511726
New Zealand	603828
South Korea	102165394
Mexico	2015003824
Eurasian Patent Organization	027666
Ukraine	109275

Supplementary Protection Certificates for Shilpa Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0564409	2002/005	Ireland		PRODUCT NAME: IMATINIB OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; NAT REGISTRATION NO/DATE: EU/1/01/198/001-006 20011107; FIRST REGISTRATION NO/DATE: CH 55807 55807 01 55807 02 20010621; PAEDIATRIC INVESTIGATION PLAN: P/0028/2012
1746976	LUC00026	Luxembourg		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL) (MOLECULAR WEIGHT 2000)-OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYL ETHANOLAMINE, E.G. IN THE MOLAR RATIO 3:2:0.015; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
0316704	2001C/021	Belgium		PRODUCT NAME: CAPECITABINE, NATL REGISTRATION NO/DATE: EU/1/00/163/001 20010205; FIRST REGISTRATION: CH 54657 19980610
0817775	C300214	Netherlands		PRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321
0275821	01C0035	France		PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
1746976	2017C/027	Belgium		PRODUCT NAME: LE SEL DE SUCROSOFATE D'IRINOTECAN, PAR EXEMPLE LE SEL DE SUCROSOFATE D'IRINOTECAN INCORPORE DANS UN LIPOSOME MODIFIE PAR PEGYLATION, TEL QU'UN LIPOSOME COMPRENANT DE LA 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLINE, DU CHOLESTEROL ET DU N- (OMEGA-METHOXY POLY (ETHYLENE GLYCOL) (POIDS MOLECULAIRE 2000) -OXYCARBONYL)-1,2-DISEEAROYLPHOSPHATIDYLETHANOLAMINE, PAR EXEMPLE DANS DES RAPPORTS MOLAIRES 3: 2: 0,015; OU COMME DEMANDE AUXILIAIRE, IRINOTECAN; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
0817775	SPC/GB06/008	United Kingdom		PRODUCT NAME: ERLOTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR POLYMORPH THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: CH 5726601 20050321; CH 5726602 20050321; CH 5726603 20050321; UK EU/1/05/311/001 20050919; UK EU/1/05/311/002 20050919; UK EU/1/05/311/003 20050919

Similar Applicant Names

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

• Shilpa
• Shilpa Medicare