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Amneal Company Profile
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AMNEAL has two hundred and seventy-nine approved drugs.
There is one US patent protecting AMNEAL drugs. There are eleven tentative approvals on AMNEAL drugs.
There are five patent family members on AMNEAL drugs in six countries and five hundred and twenty-three supplementary protection certificates in sixteen countries.
Summary for Amneal
| International Patents: | 5 |
| US Patents: | 1 |
| Tradenames: | 222 |
| Ingredients: | 216 |
| NDAs: | 279 |
| Patent Litigation for Amneal: | See patent lawsuits for Amneal |
| PTAB Cases with Amneal as petitioner: | See PTAB cases with Amneal as petitioner |
Drugs and US Patents for Amneal
| 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 | PREGABALIN | pregabalin | CAPSULE;ORAL | 209743-007 | Jul 19, 2019 | AB | RX | No | No | Start Trial | Start Trial | ||||
| Amneal Pharms Co | NADOLOL | nadolol | TABLET;ORAL | 208832-002 | Jun 2, 2017 | AB | RX | No | No | Start Trial | Start Trial | ||||
| Amneal Pharms | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 091426-003 | Jul 2, 2010 | AB | RX | No | No | Start Trial | Start Trial | ||||
| Amneal Pharms Co | PHYTONADIONE | phytonadione | TABLET;ORAL | 209373-001 | May 11, 2018 | AB | RX | No | No | Start Trial | Start Trial | ||||
| Amneal Pharms Ny | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | cetirizine hydrochloride | TABLET;ORAL | 078780-002 | Jan 21, 2010 | OTC | 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
| 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 drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ 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 |
| ➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
| ➤ Subscribe | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
International Patents for Amneal Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2881109 | Start Trial |
| Portugal | 2881109 | Start Trial |
| China | 103315947 | Start Trial |
| Russian Federation | 2015100116 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2013139179 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amneal Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0454511 | 98C0028 | Belgium | Start Trial | PRODUCT NAME: IRBESARTAN; NATL. REGISTRATION NO/DATE: EU/1/97/046/001 19970827; FIRST REGISTRATION: CH 54250 02 19970815 |
| 2203431 | CR 2015 00014 | Denmark | Start Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 |
| 1135391 | 1190009-9 | Sweden | Start Trial | PRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203 |
| 1667986 | 28/2013 | Austria | Start Trial | PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317 |
| 2603514 | CA 2019 00015 | Denmark | Start Trial | PRODUCT NAME: EN KOMBINATION AF VABORBACTAM, OG/ELLER ET SALT OG/ELLER HYDRAT DERAF, OG MEROPENEM, OG/ELLER ET SALT OG/ELLER HYDRAT DERAF, SAERLIGT MEROPENEM TRIHYDRAT; REG. NO/DATE: EU/1/18/1334 20181122 |
| >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.
