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Amneal Pharms Company Profile
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What is the competitive landscape for AMNEAL PHARMS, and when can generic versions of AMNEAL PHARMS drugs launch?
AMNEAL PHARMS has two hundred and thirty-six approved drugs.
There is one US patent protecting AMNEAL PHARMS drugs. There are thirteen tentative approvals on AMNEAL PHARMS drugs.
There are five patent family members on AMNEAL PHARMS drugs in five countries and four hundred and twenty-three supplementary protection certificates in fifteen countries.
Summary for Amneal Pharms
| International Patents: | 5 |
| US Patents: | 1 |
| Tradenames: | 183 |
| Ingredients: | 178 |
| NDAs: | 236 |
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 | ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 208850-004 | Oct 16, 2018 | DISCN | No | No | Start Trial | Start Trial | |||||
| Amneal Pharms Llc | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 210831-006 | Feb 19, 2019 | DISCN | No | No | Start Trial | Start Trial | |||||
| Amneal Pharms Ny | IBUPROFEN | ibuprofen | TABLET;ORAL | 071334-001 | Nov 25, 1986 | AB | RX | No | No | Start Trial | Start Trial | ||||
| Amneal Pharms Co | ETODOLAC | etodolac | TABLET;ORAL | 208834-001 | Jun 7, 2018 | AB | RX | No | No | Start Trial | Start Trial | ||||
| Amneal Pharms Ny | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 079096-001 | Dec 16, 2008 | OTC | No | No | Start Trial | Start Trial | |||||
| Amneal Pharms | EXEMESTANE | exemestane | TABLET;ORAL | 206421-001 | Dec 28, 2018 | DISCN | No | No | Start Trial | Start Trial | |||||
| Amneal Pharms | WARFARIN SODIUM | warfarin sodium | TABLET;ORAL | 202202-004 | Mar 4, 2013 | 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 |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013139179 | Start Trial |
| Canada | 2879383 | Start Trial |
| European Patent Office | 2881109 | Start Trial |
| Russian Federation | 2015100116 | Start Trial |
| China | 103315947 | 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 |
|---|---|---|---|---|
| 0717738 | 02C0005 | France | Start Trial | PRODUCT NAME: LINEZOLIDE; NAT. REGISTRATION NO/DATE: NL 26 660 20010831; FIRST REGISTRATION: GB - PL 00 32/0261 20010105 |
| 0548114 | SPC/GB97/064 | United Kingdom | Start Trial | PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410 |
| 0801067 | C00801067/01 | Switzerland | Start Trial | PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006 |
| 1214076 | C01214076/01 | Switzerland | Start Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| 0933372 | PA2008006,C0933372 | Lithuania | Start Trial | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
| 1411900 | SPC/GB11/015 | United Kingdom | Start Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 1506211 | 300677 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121 |
| >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.
