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 twenty-five approved drugs.
There are two US patents protecting AMNEAL drugs.
There are nine patent family members on AMNEAL drugs in nine countries and six hundred and twenty-eight supplementary protection certificates in seventeen countries.
Summary for Amneal
International Patents: | 9 |
US Patents: | 2 |
Tradenames: | 253 |
Ingredients: | 246 |
NDAs: | 325 |
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
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 | See Plans and Pricing |
>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 |
---|---|---|
Poland | 2881109 | See Plans and Pricing |
Russian Federation | 2015100116 | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2013139179 | See Plans and Pricing |
European Patent Office | 2881109 | See Plans and Pricing |
Australia | 2020323846 | See Plans and Pricing |
Portugal | 2881109 | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2021021277 | See Plans and Pricing |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amneal Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2137537 | CA 2014 00035 | Denmark | See Plans and Pricing | PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130 |
0138504 | 2004C/004 | Belgium | See Plans and Pricing | PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311 |
1467728 | 16C0019 | France | See Plans and Pricing | PRODUCT NAME: SACUBITRIL/VALSARTAN,Y COMPRIS LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
0763039 | 18/2008 | Austria | See Plans and Pricing | PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
1135391 | PA2011004 | Lithuania | See Plans and Pricing | PRODUCT NAME: TICAGRELORUM; REGISTRATION NO/DATE: EU/1/10/655/001 2010 12 03 EU/1/10/655/002 2010 12 03 EU/1/10/655/003 2010 12 03 EU/1/10/655/004 2010 12 03 EU/1/10/655/005 2010 12 03 EU/1/10/655/00 20101203 |
0206283 | C980016 | Netherlands | See Plans and Pricing | PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606 |
1506211 | PA2014026,C1506211 | Lithuania | See Plans and Pricing | PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.