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Last Updated: May 7, 2024

Amphastar Pharm Company Profile


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Summary for Amphastar Pharm
International Patents:75
US Patents:3
Tradenames:15
Ingredients:13
NDAs:16

Drugs and US Patents for Amphastar Pharm

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amphastar Pharms Inc BAQSIMI glucagon POWDER;NASAL 210134-001 Jul 24, 2019 RX Yes Yes 10,213,487 ⤷  Try a Trial Y ⤷  Try a Trial
Amphastar Pharm ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076684-004 Sep 19, 2011 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
Amphastar Pharms Inc MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate INJECTABLE;INJECTION 077334-001 Nov 28, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amphastar Pharm ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076684-007 Sep 19, 2011 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
Amphastar Pharm ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076684-005 Sep 19, 2011 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
Amphastar Pharm ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076684-002 Sep 19, 2011 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
Amphastar Pharms Inc BAQSIMI glucagon POWDER;NASAL 210134-001 Jul 24, 2019 RX Yes Yes 10,765,602 ⤷  Try a Trial Y ⤷  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 AMPHASTAR PHARM drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 250 mcg/0.5 mL, 1 mL PFS ➤ Subscribe 2012-03-30

Supplementary Protection Certificates for Amphastar Pharm Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1713823 92595 Luxembourg ⤷  Try a Trial PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
1856135 CA 2020 00018 Denmark ⤷  Try a Trial PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
2932970 SPC/GB18/041 United Kingdom ⤷  Try a Trial PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
2822954 1890030-8 Sweden ⤷  Try a Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
0579826 SPC/GB02/042 United Kingdom ⤷  Try a Trial PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
1856135 CR 2020 00018 Denmark ⤷  Try a Trial PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
1534313 76/2015 Austria ⤷  Try a Trial PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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