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Last Updated: May 19, 2024

Amphastar Pharms Inc Company Profile


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What is the competitive landscape for AMPHASTAR PHARMS INC, and what generic alternatives to AMPHASTAR PHARMS INC drugs are available?

AMPHASTAR PHARMS INC has fourteen approved drugs.

There are three US patents protecting AMPHASTAR PHARMS INC drugs.

There are seventy-six patent family members on AMPHASTAR PHARMS INC drugs in forty-one countries and seventy-three supplementary protection certificates in nine countries.

Summary for Amphastar Pharms Inc
International Patents:76
US Patents:3
Tradenames:13
Ingredients:12
NDAs:14

Drugs and US Patents for Amphastar Pharms Inc

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 MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate INJECTABLE;INJECTION 077334-001 Nov 28, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amphastar Pharms Inc NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 209933-001 Sep 25, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
Amphastar Pharms Inc MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate INJECTABLE;INJECTION 077235-001 Nov 28, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amphastar Pharms Inc ENOXAPARIN SODIUM enoxaparin sodium INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 208600-001 Mar 14, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Amphastar Pharms Inc NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 209933-002 Sep 25, 2017 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 10,894,133 ⤷  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 PHARMS INC 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 Pharms Inc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0277829 2000C/030 Belgium ⤷  Try a Trial PRODUCT NAME: GANIRELIX; REGISTRATION NO/DATE: EU/1/00/130/001 20000518
1948158 16C0018 France ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
2822954 LUC00083 Luxembourg ⤷  Try a Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
1948158 1690020-1 Sweden ⤷  Try a Trial PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
0268956 1999C0030 Belgium ⤷  Try a Trial PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
2666774 CA 2020 00037 Denmark ⤷  Try a Trial PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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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.