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-five 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: | 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 | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 076209-001 | Jul 21, 2004 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Amphastar Pharms Inc | GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 212613-001 | Apr 7, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amphastar Pharms Inc | BAQSIMI | glucagon | POWDER;NASAL | 210134-001 | Jul 24, 2019 | RX | Yes | Yes | 10,213,487 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Amphastar Pharms Inc | ISOPROTERENOL HYDROCHLORIDE | isoproterenol hydrochloride | INJECTABLE;INJECTION | 210106-001 | Jun 18, 2018 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amphastar Pharms Inc | MEDROXYPROGESTERONE ACETATE | medroxyprogesterone acetate | INJECTABLE;INJECTION | 077235-001 | Nov 28, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amphastar Pharms Inc | VASOPRESSIN | vasopressin | SOLUTION;INTRAVENOUS | 211857-001 | Jul 18, 2022 | 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 |
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 | ⤷ Try a Trial |
| >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 |
|---|---|---|
| South Africa | 201704944 | ⤷ Try a Trial |
| New Zealand | 734035 | ⤷ Try a Trial |
| Eurasian Patent Organization | 202192370 | ⤷ Try a Trial |
| Guatemala | 201700179 | ⤷ Try a Trial |
| European Patent Office | 3471894 | ⤷ Try a Trial |
| Japan | 2022000157 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amphastar Pharm Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1856135 | 2090014-8 | Sweden | ⤷ Try a Trial | 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 |
| 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 |
| 2340828 | LUC00195 | Luxembourg | ⤷ Try a Trial | 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 |
| 2203431 | 1590018-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 |
| 2380576 | 2020/043 | Ireland | ⤷ Try a Trial | PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; NAT REGISTRATION NO/DATE: PA2103/003/001 20170602; FIRST REGISTRATION NO/DATE: SE/H/1547/001/DC 20160729 |
| 1534313 | CR 2015 00072 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730 |
| >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.
