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 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 076684-001 | Sep 19, 2011 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amphastar Pharm | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 076684-002 | Sep 19, 2011 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amphastar Pharms Inc | DUOCAINE | bupivacaine hydrochloride; lidocaine hydrochloride | INJECTABLE;INJECTION | 021496-001 | May 23, 2003 | DISCN | 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 | ||||
| Amphastar Pharm | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 076209-001 | Jul 21, 2004 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Amphastar Pharm | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 076684-007 | Sep 19, 2011 | 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 |
|---|---|---|
| European Patent Office | 3946427 | ⤷ Try a Trial |
| Peru | 20171334 | ⤷ Try a Trial |
| Australia | 2021203035 | ⤷ Try a Trial |
| China | 109070122 | ⤷ Try a Trial |
| Canada | 3130823 | ⤷ Try a Trial |
| European Patent Office | 3471894 | ⤷ 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 |
|---|---|---|---|---|
| 1758590 | LUC00029 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401 |
| 2932970 | SPC/GB18/041 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518 |
| 2563920 | CA 2019 00001 | Denmark | ⤷ Try a Trial | PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710 |
| 1713823 | 1490064-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
| 0113964 | 97C0037 | Belgium | ⤷ Try a Trial | PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826 |
| 1856135 | CR 2020 00018 | Denmark | ⤷ Try a Trial | 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; REG. NO/DATE: EU/1/19/1405 20200113 |
| >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.
