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 | ISOPROTERENOL HYDROCHLORIDE | isoproterenol hydrochloride | INJECTABLE;INJECTION | 210106-001 | Jun 18, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amphastar Pharms Inc | BAQSIMI | glucagon | POWDER;NASAL | 210134-001 | Jul 24, 2019 | RX | Yes | Yes | 10,213,487 | ⤷ Sign Up | Y | ⤷ 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 | ENOXAPARIN SODIUM | enoxaparin sodium | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 208600-001 | Mar 14, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amphastar Pharms Inc | REXTOVY | naloxone hydrochloride | SPRAY, METERED;NASAL | 208969-001 | Mar 7, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | |||||
| Amphastar Pharms Inc | MEDROXYPROGESTERONE ACETATE | medroxyprogesterone acetate | INJECTABLE;INJECTION | 077235-001 | Nov 28, 2017 | 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 |
Expired US Patents for Amphastar Pharms Inc
| 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 PHARMS INC drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 250 mcg/0.5 mL, 1 mL PFS | ➤ Subscribe | 2012-03-30 |
International Patents for Amphastar Pharms Inc Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 112017014994 | ⤷ Sign Up |
| European Patent Office | 3673899 | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2016133863 | ⤷ Sign Up |
| Tunisia | 2017000349 | ⤷ Sign Up |
| Japan | 7094242 | ⤷ Sign Up |
| China | 107278154 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amphastar Pharms Inc Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0145340 | 99C0005 | Belgium | ⤷ Sign Up | PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204 |
| 0480717 | SPC/GB98/025 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115 |
| 2380576 | SPC/GB20/050 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526 |
| 3141251 | 301099 | Netherlands | ⤷ Sign Up | PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016 |
| 1175904 | 2007C/048 | Belgium | ⤷ Sign Up | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
| 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 |
| >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.
