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Last Updated: January 20, 2025

Amneal Company Profile


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Summary for Amneal

Drugs and US Patents for Amneal

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Amneal ESTRADIOL estradiol SYSTEM;TRANSDERMAL 211293-003 Feb 4, 2019 AB1 RX No No ⤷  Subscribe ⤷  Subscribe
Amneal Pharms Co ETODOLAC etodolac TABLET;ORAL 208834-001 Jun 7, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe
Amneal Pharms Co EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 208831-002 Nov 21, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe
Amneal Pharm FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 075442-002 Jul 31, 2001 AB RX No No ⤷  Subscribe ⤷  Subscribe
Amneal Pharm GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 075109-002 Nov 25, 1998 AB RX No Yes ⤷  Subscribe ⤷  Subscribe
Amneal Pharms LACOSAMIDE lacosamide TABLET;ORAL 204857-004 Mar 17, 2022 DISCN No No ⤷  Subscribe ⤷  Subscribe
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

Expired US Patents for Amneal

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Amneal ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907-001 Nov 18, 1998 RE36247 ⤷  Subscribe
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-003 Sep 16, 2013 6,750,237*PED ⤷  Subscribe
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 7,220,767*PED ⤷  Subscribe
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-003 Sep 16, 2013 7,220,767*PED ⤷  Subscribe
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 5,466,699*PED ⤷  Subscribe
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 6,750,237*PED ⤷  Subscribe
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 6 of 6 entries
Paragraph IV (Patent) Challenges for AMNEAL drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Nasal Spray 2.5 mg/spray ➤ Subscribe 2016-06-09
➤ 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

Supplementary Protection Certificates for Amneal Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0984957 122012000017 Germany ⤷  Subscribe PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
1907382 300848 Netherlands ⤷  Subscribe PRODUCT NAME: OPICAPON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1066 20160628
0720599 92544 Luxembourg ⤷  Subscribe PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724
1907382 93327 Luxembourg ⤷  Subscribe PRODUCT NAME: OPICAPONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/15/1066 - ONGENTYS - OPICAPONE
0219829 SPC/GB06/034 United Kingdom ⤷  Subscribe PRODUCT NAME: CLOFARABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/06/334/001 20060529; UK EU/1/06/334/002 20060529; UK EU/1/06/334/003 20060529; UK EU/1/06/334/004 20060529
0123238 SPC/GB95/004 United Kingdom ⤷  Subscribe PRODUCT NAME: ATOVAQUONE OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: LU 0458/94/08/0741 19940803; UK 0003/0337 19940823
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 6 of 6 entries
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.