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Last Updated: February 20, 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 MEROPENEM meropenem INJECTABLE;INJECTION 205883-002 Apr 12, 2016 AP RX No No   Start Trial   Start Trial
Amneal FULVESTRANT fulvestrant INJECTABLE;INTRAMUSCULAR 210044-001 Mar 4, 2019 AO RX No No   Start Trial   Start Trial
Amneal Pharms Ny IBUPROFEN ibuprofen TABLET;ORAL 072199-001 May 23, 1988 OTC No No   Start Trial   Start Trial
Amneal Pharms ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 205619-002 May 17, 2017 AB RX No No   Start Trial   Start Trial
Amneal Pharms MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205081-004 Apr 22, 2016 DISCN No No   Start Trial   Start Trial
Amneal Pharms Co ERYTHROMYCIN erythromycin TABLET;ORAL 209720-001 Mar 9, 2018 AB RX No No   Start Trial   Start Trial
Amneal Pharms Llc MESALAMINE mesalamine SUPPOSITORY;RECTAL 210509-001 Jan 2, 2020 AB RX 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 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
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24

Supplementary Protection Certificates for Amneal Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 CA 2008 00035 Denmark   Start Trial PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
0166287 SPC/GB96/056 United Kingdom   Start Trial PRODUCT NAME: PANTOPRAZOLE AND ITS SALTS, HYDRATES AND HYDRATES OF ITS SALTS; REGISTERED: SE SE12131 19940506; UK 04889/0010 19960604
2932970 1890039-9 Sweden   Start Trial PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518
0720599 SPC/GB05/010 United Kingdom   Start Trial PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411
0770388 SPC/GB09/026 United Kingdom   Start Trial PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
0579826 02C0041 France   Start Trial PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
1214076 SZ 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
>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:

Express Scripts
Baxter
AstraZeneca
Johnson and Johnson
Moodys
Harvard Business School

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