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Last Updated: March 18, 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 CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078780-001 Jan 21, 2010 OTC No No ⤷  Try a Trial ⤷  Try a Trial
Amneal CALCIUM GLUCONATE IN SODIUM CHLORIDE calcium gluconate SOLUTION;INTRAVENOUS 217174-001 Sep 5, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms METAXALONE metaxalone TABLET;ORAL 203399-001 Jun 21, 2013 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial
Amneal POSACONAZOLE posaconazole TABLET, DELAYED RELEASE;ORAL 216626-001 Dec 22, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amneal NAFTIFINE HYDROCHLORIDE naftifine hydrochloride GEL;TOPICAL 206165-001 Mar 20, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms Co CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride TABLET;ORAL 209755-004 Sep 10, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amneal VASOPRESSIN vasopressin SOLUTION;INTRAVENOUS 212944-001 Aug 5, 2022 AP RX No No ⤷  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

Expired US Patents for Amneal

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-003 Sep 16, 2013 6,750,237*PED ⤷  Try a Trial
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 7,220,767*PED ⤷  Try a Trial
Amneal ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907-001 Nov 18, 1998 RE36247 ⤷  Try a Trial
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 6,750,237*PED ⤷  Try a Trial
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-003 Sep 16, 2013 7,220,767*PED ⤷  Try a Trial
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 5,466,699*PED ⤷  Try a Trial
>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 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
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16

Supplementary Protection Certificates for Amneal Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2603514 19C1021 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON DE VABORBACTAME, ET/OU D'UN SEL ET/OU D'UN HYDRATE DE CELUI-CI, ET DE MEROPENEME, ET/OU D'UN SEL ET/OU D'UN HYDRATE DE CELUI-CI, EN PARTICULIER DE MEROPENEME TRIHYDRATE; REGISTRATION NO/DATE: EU/1/18/1334 20181122
1532149 PA2012022 Lithuania ⤷  Try a Trial PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1131065 1490039-3 Sweden ⤷  Try a Trial PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140130
0564409 2002/005 Ireland ⤷  Try a Trial PRODUCT NAME: IMATINIB OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; NAT REGISTRATION NO/DATE: EU/1/01/198/001-006 20011107; FIRST REGISTRATION NO/DATE: CH 55807 55807 01 55807 02 20010621; PAEDIATRIC INVESTIGATION PLAN: P/0028/2012
0290047 SPC/GB97/078 United Kingdom ⤷  Try a Trial PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
2137537 SPC/GB14/046 United Kingdom ⤷  Try a Trial PRODUCT NAME: DIMETHYL FUMARATE; REGISTERED: UK EU/1/13/837 20140203
1519731 C300740 Netherlands ⤷  Try a Trial PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
>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.