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Last Updated: May 31, 2023

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 OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 209093-002 May 17, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 079098-001 May 11, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms Co ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 208850-004 Oct 16, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 203872-001 Dec 22, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms Ny IBUPROFEN ibuprofen TABLET;ORAL 078558-001 Jun 18, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms ESTRADIOL estradiol TABLET;VAGINAL 205256-001 May 29, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amneal ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907-001 Nov 18, 1998 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a 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 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

Supplementary Protection Certificates for Amneal Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0759917 38/2002 Austria ⤷  Try a Trial PRODUCT NAME: OSELTAMIVIR PHOSPHAT; REGISTRATION NO/DATE: EU/1/02/222/001 EU/1/02/222/002 20020620
1429780 SPC/GB12/058 United Kingdom ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
2962690 1990037-2 Sweden ⤷  Try a Trial PRODUCT NAME: APREMILAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/981 20150116
1718641 SPC/GB12/028 United Kingdom ⤷  Try a Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
2380576 SPC/GB20/050 United Kingdom ⤷  Try a Trial PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
2365988 CA 2018 00006 Denmark ⤷  Try a Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
1506211 122014000070 Germany ⤷  Try a Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; 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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