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Last Updated: July 16, 2024

Amphastar Pharm Company Profile


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Summary for Amphastar Pharm
International Patents:76
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 KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 076209-002 Jul 21, 2004 DISCN No No ⤷  Sign Up ⤷  Sign Up
Amphastar Pharms Inc DUOCAINE bupivacaine hydrochloride; lidocaine hydrochloride INJECTABLE;INJECTION 021496-001 May 23, 2003 DISCN No No ⤷  Sign Up ⤷  Sign Up
Amphastar Pharms Inc SUCCINYLCHOLINE CHLORIDE succinylcholine chloride INJECTABLE;INJECTION 213432-001 Jun 8, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up
Amphastar Pharm ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076684-005 Sep 19, 2011 AP RX No No ⤷  Sign Up ⤷  Sign Up
Amphastar Pharm ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076684-003 Sep 19, 2011 AP RX No No ⤷  Sign Up ⤷  Sign Up
Amphastar Pharms Inc ENOXAPARIN SODIUM enoxaparin sodium INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 208600-001 Mar 14, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up
>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
2822954 LUC00083 Luxembourg ⤷  Sign Up PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
0788511 SPC/GB08/036 United Kingdom ⤷  Sign Up PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
2203431 CR 2015 00014 Denmark ⤷  Sign Up PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
2822954 SPC/GB18/031 United Kingdom ⤷  Sign Up PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
1534313 92923 Luxembourg ⤷  Sign Up PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
1874117 SPC/GB14/041 United Kingdom ⤷  Sign Up PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
>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.