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Last Updated: May 22, 2022

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 METHYLPREDNISOLONE methylprednisolone TABLET;ORAL 207481-004 Sep 21, 2021 DISCN No No See Plans and Pricing See Plans and Pricing
Amneal METHYLPREDNISOLONE methylprednisolone TABLET;ORAL 207481-002 Sep 21, 2021 DISCN No No See Plans and Pricing See Plans and Pricing
Amneal CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075939-003 Jun 9, 2004 DISCN No No See Plans and Pricing See Plans and Pricing
Amneal Pharms Co BUMETANIDE bumetanide TABLET;ORAL 209724-001 Oct 18, 2017 AB RX No No See Plans and Pricing See Plans and Pricing
Amneal Pharms ARIPIPRAZOLE aripiprazole SOLUTION;ORAL 203906-001 Aug 14, 2015 AA RX No Yes See Plans and Pricing See Plans and Pricing
Amneal DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 208888-001 Feb 17, 2017 AP RX No No See Plans and Pricing See Plans and Pricing
Amneal Pharms LACOSAMIDE lacosamide TABLET;ORAL 204857-001 Mar 17, 2022 AB RX No No See Plans and Pricing See Plans and Pricing
>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 for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24

International Patents for Amneal Drugs

Country Patent Number Estimated Expiration
Poland 2881109 See Plans and Pricing
Russian Federation 2015100116 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2013139179 See Plans and Pricing
European Patent Office 2881109 See Plans and Pricing
Australia 2020323846 See Plans and Pricing
Portugal 2881109 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2021021277 See Plans and Pricing
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for Amneal Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2137537 CA 2014 00035 Denmark See Plans and Pricing PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
0138504 2004C/004 Belgium See Plans and Pricing PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311
1467728 16C0019 France See Plans and Pricing PRODUCT NAME: SACUBITRIL/VALSARTAN,Y COMPRIS LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1058 20151123
0763039 18/2008 Austria See Plans and Pricing PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
1135391 PA2011004 Lithuania See Plans and Pricing PRODUCT NAME: TICAGRELORUM; REGISTRATION NO/DATE: EU/1/10/655/001 2010 12 03 EU/1/10/655/002 2010 12 03 EU/1/10/655/003 2010 12 03 EU/1/10/655/004 2010 12 03 EU/1/10/655/005 2010 12 03 EU/1/10/655/00 20101203
0206283 C980016 Netherlands See Plans and Pricing PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
1506211 PA2014026,C1506211 Lithuania See Plans and Pricing PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
>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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