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 ninety-nine approved drugs.
There are fourteen US patents protecting AMNEAL drugs. There are seven tentative approvals on AMNEAL drugs.
There are one hundred and twenty patent family members on AMNEAL drugs in thirty-one countries and eight hundred and thirty-five supplementary protection certificates in nineteen countries.
Summary for Amneal
| International Patents: | 120 |
| US Patents: | 14 |
| Tradenames: | 303 |
| Ingredients: | 293 |
| NDAs: | 399 |
| 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 | METAXALONE | metaxalone | TABLET;ORAL | 203399-001 | Jun 21, 2013 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal | CLOBETASOL PROPIONATE | clobetasol propionate | OINTMENT;TOPICAL | 210551-001 | Aug 21, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Amneal | VERAPAMIL HYDROCHLORIDE | verapamil hydrochloride | SOLUTION;INTRAVENOUS | 210994-002 | Jul 13, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal Pharms | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 207289-001 | Jun 27, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal | METHYLPREDNISOLONE SODIUM SUCCINATE | methylprednisolone sodium succinate | INJECTABLE;INJECTION | 207549-001 | Nov 9, 2016 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal | CLOBETASOL PROPIONATE | clobetasol propionate | CREAM;TOPICAL | 211256-001 | Dec 26, 2018 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-003 | Sep 16, 2013 | 6,750,237*PED | ⤷ Sign Up |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 6,750,237*PED | ⤷ Sign Up |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 7,220,767*PED | ⤷ Sign Up |
| Amneal | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | RE36247 | ⤷ Sign Up |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 5,466,699*PED | ⤷ Sign Up |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-003 | Sep 16, 2013 | 7,220,767*PED | ⤷ Sign Up |
| >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 | Nasal Spray | 2.5 mg/spray | ➤ Subscribe | 2016-06-09 |
| ➤ Subscribe | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
| ➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
| ➤ Subscribe | Nasal Spray | 5 mg/spray | ➤ Subscribe | 2013-11-14 |
| ➤ 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 |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2007013830 | ⤷ Sign Up |
| Mexico | 2011010415 | ⤷ Sign Up |
| European Patent Office | 2791134 | ⤷ Sign Up |
| Russian Federation | 2011144145 | ⤷ Sign Up |
| Spain | 2795421 | ⤷ Sign Up |
| Norway | 20092905 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amneal Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2487163 | CA 2017 00003 | Denmark | ⤷ Sign Up | PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG ATAZANAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER ATAZANAVIRSULFAT; REG. NO/DATE: EU/1/15/1025/001-002 20150715 |
| 1506211 | PA2014026 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
| 2487163 | 2016C/066 | Belgium | ⤷ Sign Up | PRODUCT NAME: COBICISTAT ET ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025 20150715 |
| 0502314 | 1190006-5.L | Sweden | ⤷ Sign Up | PRODUCT NAME: TELMISARTAN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT, OCH AMLODIPIN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT SAERSKILT AMOLODIPINBESILAT; REG. NO/DATE: EU/1/10/648/001-028 " EESGODKLANDKOD="EG" EESGODKDATUM="2010-10-07" SEGODKNR="EU/1/10/648/001-028 " SEGODKLANDKOD="EG" SEGODKDATUM="2010-10-07" FLAG="L" SPCNR="1190006-5" 20101007 |
| 0716606 | C00716606/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004 |
| 0387077 | SPC/GB04/003 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: PARICALCITOL; REGISTERED: ES SPAIN 64.974 20020809; UK PL 00037/0403 20030721 |
| >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.
