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 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 | 10,765,602 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Amphastar Pharm | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 076684-005 | Sep 19, 2011 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amphastar Pharms Inc | ENOXAPARIN SODIUM | enoxaparin sodium | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 208600-001 | Mar 14, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amphastar Pharms Inc | NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 209933-002 | Sep 25, 2017 | 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 |
|---|---|---|
| Costa Rica | 20170373 | ⤷ Try a Trial |
| Japan | 2018507852 | ⤷ Try a Trial |
| Morocco | 41547 | ⤷ Try a Trial |
| Singapore | 11201705640P | ⤷ Try a Trial |
| Ecuador | SP17053843 | ⤷ 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 |
|---|---|---|---|---|
| 0290047 | 97C0108 | Belgium | ⤷ Try a Trial | PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522 |
| 2203431 | CR 2015 00014 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 |
| 2203431 | 2015/009 | Ireland | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115 |
| 1874117 | SPC/GB14/041 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121 |
| 2673237 | 1990016-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; REG. NO/DATE: EU/1/17/1173 20180326 |
| >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.
