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 |
| Patent Litigation for Amphastar Pharm: | See patent lawsuits for Amphastar Pharm |
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 | MEDROXYPROGESTERONE ACETATE | medroxyprogesterone acetate | INJECTABLE;INJECTION | 077235-001 | Nov 28, 2017 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Amphastar Pharms Inc | ISOPROTERENOL HYDROCHLORIDE | isoproterenol hydrochloride | INJECTABLE;INJECTION | 210106-001 | Jun 18, 2018 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Amphastar Pharm | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 076684-002 | Sep 19, 2011 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Amphastar Pharms Inc | BAQSIMI | glucagon | POWDER;NASAL | 210134-001 | Jul 24, 2019 | RX | Yes | Yes | 10,894,133 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Amphastar Pharms Inc | GLUCAGON | glucagon | INJECTABLE;INJECTION | 208086-001 | Dec 28, 2020 | RX | No | Yes | ⤷ Subscribe | ⤷ Subscribe | |||||
| >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 | ⤷ Subscribe |
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 3258919 | ⤷ Subscribe |
| Japan | 2019521050 | ⤷ Subscribe |
| China | 113613671 | ⤷ Subscribe |
| World Intellectual Property Organization (WIPO) | 2016133863 | ⤷ Subscribe |
| Canada | 3130823 | ⤷ Subscribe |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amphastar Pharm Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0186405 | SPC/GB00/021 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316 |
| 2340828 | LUC00195 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123 |
| 1856135 | 2090014-8 | Sweden | ⤷ Subscribe | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113 |
| 1856135 | 2020/017 | Ireland | ⤷ Subscribe | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTRATION NO/DATE: EU/1/19/1405 20200113 |
| 0268956 | 1999C0030 | Belgium | ⤷ Subscribe | PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508 |
| >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.
