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Last Updated: May 28, 2024

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 Ny PREDNISONE prednisone TABLET;ORAL 089597-001 Oct 5, 1987 DISCN No No ⤷  Sign Up ⤷  Sign Up
Amneal Pharms SPIRONOLACTONE spironolactone TABLET;ORAL 091426-003 Jul 2, 2010 AB RX No No ⤷  Sign Up ⤷  Sign Up
Amneal Pharms Ny AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078477-001 Jan 16, 2008 DISCN No No ⤷  Sign Up ⤷  Sign Up
Amneal Pharms Ny HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040813-001 Feb 23, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up
Amneal Pharms Co DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 207482-003 Jun 28, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Amneal

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 5,466,699*PED ⤷  Sign Up
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-003 Sep 16, 2013 6,750,237*PED ⤷  Sign Up
Amneal ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907-001 Nov 18, 1998 RE36247 ⤷  Sign Up
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 6,750,237*PED ⤷  Sign Up
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-003 Sep 16, 2013 7,220,767*PED ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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 Nasal Spray 5 mg/spray ➤ Subscribe 2013-11-14
➤ 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
➤ Subscribe Nasal Spray 2.5 mg/spray ➤ Subscribe 2016-06-09

Supplementary Protection Certificates for Amneal Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487163 381 2-2017 Slovakia ⤷  Sign Up PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/ATAZANAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1025 20150715
2487163 60/2016 Austria ⤷  Sign Up PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715
3150586 2020C/515 Belgium ⤷  Sign Up PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN HET BIJZONDER DARUNAVIR ETHANOLATE, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925
2498758 2090013-0 Sweden ⤷  Sign Up PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113
1411900 2011C/016 Belgium ⤷  Sign Up PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.