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Last Updated: May 8, 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 Pharm ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076684-001 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 SUCCINYLCHOLINE CHLORIDE succinylcholine chloride INJECTABLE;INJECTION 213432-001 Jun 8, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Amphastar Pharm ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076684-003 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
1534313 C 2015 055 Romania ⤷  Try a Trial PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA
1713823 1490064-1 Sweden ⤷  Try a Trial PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
1534313 2015/071 Ireland ⤷  Try a Trial PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
0113964 97C0037 Belgium ⤷  Try a Trial PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
>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.