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 eighty-four approved drugs.
There are five US patents protecting AMNEAL drugs. There are seven tentative approvals on AMNEAL drugs.
There are fifteen patent family members on AMNEAL drugs in twelve countries and eight hundred supplementary protection certificates in eighteen countries.
Summary for AMNEAL
| International Patents: | 15 |
| US Patents: | 5 |
| Tradenames: | 291 |
| Ingredients: | 283 |
| NDAs: | 384 |
| 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 | ESTRADIOL AND PROGESTERONE | estradiol; progesterone | CAPSULE;ORAL | 214293-001 | May 16, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Amneal Pharms Co | LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 208002-001 | Jan 3, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharm | DEMECLOCYCLINE HYDROCHLORIDE | demeclocycline hydrochloride | TABLET;ORAL | 065425-001 | Feb 27, 2008 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms | CAPECITABINE | capecitabine | TABLET;ORAL | 204741-001 | Feb 28, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Amneal | ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS | 215342-001 | Jan 26, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal | IPRATROPIUM BROMIDE | ipratropium bromide | SPRAY, METERED;NASAL | 215104-001 | Aug 16, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms Ny | TETRACYCLINE HYDROCHLORIDE | tetracycline hydrochloride | CAPSULE;ORAL | 210674-002 | Sep 18, 2018 | AB | RX | No | 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 | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 7,220,767*PED | ⤷ Try a Trial |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 5,466,699*PED | ⤷ Try a Trial |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-003 | Sep 16, 2013 | 6,750,237*PED | ⤷ Try a Trial |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 6,750,237*PED | ⤷ Try a Trial |
| Amneal | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | RE36247 | ⤷ Try a Trial |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-003 | Sep 16, 2013 | 7,220,767*PED | ⤷ 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 | Injection | 100 mg/mL, 2.5 mL vials | ➤ Subscribe | 2007-09-24 |
| ➤ 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 |
International Patents for AMNEAL Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013139179 | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2021021277 | ⤷ Try a Trial |
| China | 103315947 | ⤷ Try a Trial |
| Russian Federation | 2015100116 | ⤷ Try a Trial |
| Australia | 2020323846 | ⤷ Try a Trial |
| Canada | 2879383 | ⤷ Try a Trial |
| Japan | 2022544901 | ⤷ 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 |
|---|---|---|---|---|
| 0648494 | 01C0037 | France | ⤷ Try a Trial | PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001-005 20010313; FIRST REGISTRATION: IKS55243 20000926 |
| 2957286 | 1990003-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721 |
| 0463756 | 99C0007 | Belgium | ⤷ Try a Trial | PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622 |
| 1506211 | CR 2014 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
| 1532149 | PA2012022 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720 |
| 0674513 | C00674513 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213 |
| 3150586 | PA2020508 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: KOBICISTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921 |
| >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.
