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Last Updated: May 20, 2024

AMNEAL Company Profile


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What is the competitive landscape for AMNEAL, and when can generic versions of AMNEAL drugs launch?

AMNEAL has three hundred and eighty-seven approved drugs.

There are six US patents protecting AMNEAL drugs. There are seven tentative approvals on AMNEAL drugs.

There are sixteen patent family members on AMNEAL drugs in twelve countries and eight hundred supplementary protection certificates in eighteen countries.

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 ARIPIPRAZOLE aripiprazole SOLUTION;ORAL 203906-001 Aug 14, 2015 AA RX No Yes ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 205119-001 Jan 26, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms Ny GABAPENTIN gabapentin CAPSULE;ORAL 078428-002 Jul 25, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amneal METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 210043-002 May 20, 2019 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms Co CLOBAZAM clobazam TABLET;ORAL 209718-001 Oct 22, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amneal LYVISPAH baclofen GRANULES;ORAL 215422-003 Nov 22, 2021 RX Yes Yes 11,931,328 ⤷  Try a Trial Y ⤷  Try a Trial
Amneal DEXAMETHASONE dexamethasone TABLET;ORAL 215106-002 Oct 14, 2021 AB 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 021450-004 Sep 30, 2003 5,466,699*PED ⤷  Try a Trial
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-003 Sep 16, 2013 6,750,237*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 7,220,767*PED ⤷  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
>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
0454511 99C0009 Belgium ⤷  Try a Trial PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0771217 07C0001 France ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
2962690 C20190029 00295 Estonia ⤷  Try a Trial PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015
0503785 CA 2011 00026 Denmark ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
1411900 18/2011 Austria ⤷  Try a Trial PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105
0637297 01C0027 France ⤷  Try a Trial PRODUCT NAME: BEXAROTENE; REGISTRATION NO/DATE: EU/1/01/178/001 20010329
1884242 92550 Luxembourg ⤷  Try a Trial PRODUCT NAME: LURASIDONE, FACULTATIVEMENT SOUS FORME DE SA BASE LIBRE OU DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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