Last Updated: November 8, 2026

Shilpa Company Profile

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What is the competitive landscape for SHILPA

SHILPA has six approved drugs.

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

Summary for Shilpa
US Patents:5
Tradenames:6
Ingredients:6
NDAs:6
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 9,308,195 ⤷  Start Trial Y ⤷  Start Trial
Shilpa DOCETAXEL docetaxel INJECTABLE;INJECTION 205934-002 Dec 22, 2015 AP RX Yes Yes 10,842,770 ⤷  Start Trial Y ⤷  Start Trial
Shilpa DOCETAXEL docetaxel INJECTABLE;INJECTION 205934-003 Dec 22, 2015 AP RX Yes Yes 9,308,195 ⤷  Start Trial Y ⤷  Start Trial
Shilpa PEMETREXED pemetrexed disodium SOLUTION;INTRAVENOUS 215179-003 May 22, 2023 RX Yes Yes 11,147,817 ⤷  Start Trial Y ⤷  Start Trial
Shilpa CAPECITABINE capecitabine TABLET;ORAL 207456-002 Dec 12, 2016 AB RX No No ⤷  Start Trial ⤷  Start Trial
Shilpa BORTEZOMIB bortezomib SOLUTION;INTRAVENOUS, SUBCUTANEOUS 212782-001 Aug 26, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for Shilpa Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2962690 CR 2019 00033 Denmark ⤷  Start Trial PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116
2962690 132019000000096 Italy ⤷  Start Trial PRODUCT NAME: APREMILAST(OTEZLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/981, 20150116
0564409 SPC/GB02/016 United Kingdom ⤷  Start Trial PRODUCT NAME: IMATINIB (INN I.E. NON INTELLECTUAL PROPRIETARY NAME) OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; REGISTERED: CH IKS-NR: 55807 20010621; UK SG(2001) D/292083 20011108
2962690 122019000070 Germany ⤷  Start Trial PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 20150115
2962690 C201930044 Spain ⤷  Start Trial PRODUCT NAME: APREMILAST O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115
0316704 C300045 Netherlands ⤷  Start Trial PRODUCT NAME: CAPECITABINE,DESGEWENST IN DE VORM VAN EEN SOLVAAT; NATL REGISTRATION NO/DATE: EU/1/00/163/001-002 20010202; FIRST REGISTRATION: CH 54657 19980610
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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