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Last Updated: July 6, 2020

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Amneal Company Profile


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Summary for Amneal

Drugs and US Patents for Amneal

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Co PREGABALIN pregabalin CAPSULE;ORAL 209743-007 Jul 19, 2019 AB RX No No   Start Trial   Start Trial
Amneal Pharms Co NADOLOL nadolol TABLET;ORAL 208832-002 Jun 2, 2017 AB RX No No   Start Trial   Start Trial
Amneal Pharms SPIRONOLACTONE spironolactone TABLET;ORAL 091426-003 Jul 2, 2010 AB RX No No   Start Trial   Start Trial
Amneal Pharms Co PHYTONADIONE phytonadione TABLET;ORAL 209373-001 May 11, 2018 AB RX No No   Start Trial   Start Trial
Amneal Pharms Ny CETIRIZINE HYDROCHLORIDE HIVES RELIEF cetirizine hydrochloride TABLET;ORAL 078780-002 Jan 21, 2010 OTC No No   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
Paragraph IV (Patent) Challenges for AMNEAL drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01

Supplementary Protection Certificates for Amneal Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0454511 98C0028 Belgium   Start Trial PRODUCT NAME: IRBESARTAN; NATL. REGISTRATION NO/DATE: EU/1/97/046/001 19970827; FIRST REGISTRATION: CH 54250 02 19970815
2203431 CR 2015 00014 Denmark   Start Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
1135391 1190009-9 Sweden   Start Trial PRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203
1667986 28/2013 Austria   Start Trial PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
2603514 CA 2019 00015 Denmark   Start Trial PRODUCT NAME: EN KOMBINATION AF VABORBACTAM, OG/ELLER ET SALT OG/ELLER HYDRAT DERAF, OG MEROPENEM, OG/ELLER ET SALT OG/ELLER HYDRAT DERAF, SAERLIGT MEROPENEM TRIHYDRAT; REG. NO/DATE: EU/1/18/1334 20181122
>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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Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Mallinckrodt
McKinsey
Dow
Boehringer Ingelheim

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