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Last Updated: March 1, 2024

Amphastar Pharm Company Profile


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

AMPHASTAR PHARM has sixteen approved drugs.

There are three US patents protecting AMPHASTAR PHARM drugs.

There are seventy-five patent family members on AMPHASTAR PHARM drugs in forty-one countries and eighty supplementary protection certificates in eleven countries.

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 REXTOVY naloxone hydrochloride SPRAY, METERED;NASAL 208969-001 Mar 7, 2023 DISCN Yes 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 076684-002 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 KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 076209-001 Jul 21, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Amphastar Pharm ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076684-006 Sep 19, 2011 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
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
1259550 08C0052 France ⤷  Try a Trial PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1534313 CA 2015 00072 Denmark ⤷  Try a Trial PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1856135 LUC00153 Luxembourg ⤷  Try a Trial PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
1534313 122015000111 Germany ⤷  Try a Trial PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
2822954 2018/031 Ireland ⤷  Try a Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625
1912999 2014/058 Ireland ⤷  Try a Trial PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
>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.