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-six patent family members on AMPHASTAR PHARM drugs in forty-one countries and eighty-two supplementary protection certificates in eleven countries.
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 Pharms Inc | CORTROSYN | cosyntropin | INJECTABLE;INJECTION | 016750-001 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ 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 | SODIUM NITROPRUSSIDE | sodium nitroprusside | INJECTABLE;INJECTION | 209832-001 | Dec 18, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Amphastar Pharms Inc | NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 209933-001 | Sep 25, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amphastar Pharms Inc | NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 209933-002 | Sep 25, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amphastar Pharms Inc | GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 212613-001 | Apr 7, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amphastar Pharm | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 076684-006 | Sep 19, 2011 | AP | 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 |
Expired US Patents for Amphastar Pharm
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Amphastar Pharms Inc | BAQSIMI | glucagon | POWDER;NASAL | 210134-001 | Jul 24, 2019 | 6,938,798 | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
International Patents for Amphastar Pharm Drugs
Supplementary Protection Certificates for Amphastar Pharm Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 0473687 | SPC/GB98/030 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204 |
| 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 |
| 2380576 | 20C1048 | France | ⤷ Sign Up | PRODUCT NAME: SEL DE SODIUM DE L'ACIDE DESOXYCHOLIQUE; NAT. REGISTRATION NO/DATE: NL46299 20180810; FIRST REGISTRATION: IS - IS/1/16/071/01 20160729 |
| 2673237 | LUC00111 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326 |
| 0290047 | SPC/GB97/078 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522 |
| 1534313 | 15C0090 | France | ⤷ Sign Up | PRODUCT NAME: 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; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
