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Amneal Pharms Company Profile
What is the competitive landscape for AMNEAL PHARMS, and when can generic versions of AMNEAL PHARMS drugs launch?
AMNEAL PHARMS has two hundred and fifty-seven approved drugs.
There is one US patent protecting AMNEAL PHARMS drugs. There are twelve tentative approvals on AMNEAL PHARMS drugs.
There are five patent family members on AMNEAL PHARMS drugs in five countries and four hundred and fifty-nine supplementary protection certificates in fifteen countries.
Summary for Amneal Pharms
| International Patents: | 5 |
| US Patents: | 1 |
| Tradenames: | 203 |
| Ingredients: | 197 |
| NDAs: | 257 |
Drugs and US Patents for Amneal Pharms
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms Co | DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 208888-001 | Feb 17, 2017 | AP | RX | No | No | Start Trial | Start Trial | ||||
| Amneal Pharms Llc | CLOBETASOL PROPIONATE | clobetasol propionate | CREAM;TOPICAL | 211256-001 | Dec 26, 2018 | AB1 | RX | No | No | Start Trial | Start Trial | ||||
| Amneal Pharms Ny | SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 202023-002 | Jun 27, 2018 | AB | RX | No | No | Start Trial | Start Trial | ||||
| Amneal Pharms | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 203136-001 | Feb 22, 2013 | AB | RX | No | No | Start Trial | Start Trial | ||||
| Amneal Pharms | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 204940-001 | Nov 27, 2015 | AB | RX | No | No | Start Trial | Start 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 Amneal Pharms
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Amneal Pharms Llc | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | RE36247 | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for AMNEAL PHARMS drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
| ➤ Subscribe | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
| ➤ Subscribe | Injection | 100 mg/mL, 2.5 mL vials | ➤ Subscribe | 2007-09-24 |
| ➤ Subscribe | for Injection | 100 mcg/vial and 500 mcg/vial | ➤ Subscribe | 2015-04-14 |
International Patents for Amneal Pharms Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2015100116 | Start Trial |
| China | 103315947 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2013139179 | Start Trial |
| European Patent Office | 2881109 | Start Trial |
| Canada | 2879383 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amneal Pharms Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1261586 | 1290013-0 | Sweden | Start Trial | PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124 |
| 2101777 | CA 2016 00024 | Denmark | Start Trial | PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125 |
| 1304992 | PA2013025,C1304992 | Lithuania | Start Trial | PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323 |
| 0166287 | 96C0032 | Belgium | Start Trial | PRODUCT NAME: PANTOPRAZOL. NATR. SESQUIHYDRAS PANTOPRAZOLE; NAT. REGISTRATION NO/DATE: 127 IS 98 F 3 19960222; FIRST REGISTRATION: SE 12131 19940506 |
| 0536515 | 300244 | Netherlands | Start Trial | PRODUCT: TIGECYCLINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX, IN HET BIJZONDER TIGECYCLINE; FIRST REGISTRATION, DATE: EU/1/06/336/001, 20060424 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
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Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
