Amneal Company Profile
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What is the competitive landscape for AMNEAL, and when can generic versions of AMNEAL drugs launch?
AMNEAL has three hundred and fifty-three approved drugs.
There are three US patents protecting AMNEAL drugs. There are thirteen tentative approvals on AMNEAL drugs.
There are fourteen patent family members on AMNEAL drugs in eleven countries and six hundred and sixty-four supplementary protection certificates in eighteen countries.
Summary for Amneal
| International Patents: | 14 |
| US Patents: | 3 |
| Tradenames: | 269 |
| Ingredients: | 261 |
| NDAs: | 353 |
| 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 | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 209093-002 | May 17, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET;ORAL | 079098-001 | May 11, 2010 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms Co | ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 208850-004 | Oct 16, 2018 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Amneal Pharms | LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 203872-001 | Dec 22, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms Ny | IBUPROFEN | ibuprofen | TABLET;ORAL | 078558-001 | Jun 18, 2007 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms | ESTRADIOL | estradiol | TABLET;VAGINAL | 205256-001 | May 29, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | AB | RX | Yes | Yes | ⤷ 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 Amneal
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Amneal | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | RE36247 | ⤷ Try a 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 | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
| ➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
| ➤ Subscribe | for Injection | 100 mcg/vial and 500 mcg/vial | ➤ Subscribe | 2015-04-14 |
| ➤ Subscribe | Injection | 100 mg/mL, 2.5 mL vials | ➤ Subscribe | 2007-09-24 |
International Patents for Amneal Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2879383 | ⤷ Try a Trial |
| Poland | 2881109 | ⤷ Try a Trial |
| Spain | 2795421 | ⤷ Try a Trial |
| Brazil | 112022001591 | ⤷ Try a Trial |
| Portugal | 2881109 | ⤷ Try a Trial |
| Japan | 2022544901 | ⤷ Try a Trial |
| China | 103315947 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amneal Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0759917 | 38/2002 | Austria | ⤷ Try a Trial | PRODUCT NAME: OSELTAMIVIR PHOSPHAT; REGISTRATION NO/DATE: EU/1/02/222/001 EU/1/02/222/002 20020620 |
| 1429780 | SPC/GB12/058 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003 |
| 2962690 | 1990037-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: APREMILAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/981 20150116 |
| 1718641 | SPC/GB12/028 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209 |
| 2380576 | SPC/GB20/050 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526 |
| 2365988 | CA 2018 00006 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721 |
| 1506211 | 122014000070 | Germany | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
| >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.
