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-seven approved drugs.
There are six US patents protecting AMNEAL drugs. There are seven tentative approvals on AMNEAL drugs.
There are sixteen patent family members on AMNEAL drugs in twelve countries and eight hundred supplementary protection certificates in eighteen countries.
Summary for Amneal
| International Patents: | 16 |
| US Patents: | 6 |
| Tradenames: | 293 |
| Ingredients: | 285 |
| NDAs: | 387 |
| 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 | PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 214193-002 | Sep 21, 2020 | AT | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms Co | EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 208831-001 | Nov 21, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms | CETIRIZINE HYDROCHLORIDE | cetirizine hydrochloride | SOLUTION;ORAL | 090766-001 | Oct 7, 2009 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms Ny | IBUPROFEN | ibuprofen | TABLET;ORAL | 071334-001 | Nov 25, 1986 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 210831-010 | Feb 19, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Amneal Pharms | TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 205501-001 | Jul 13, 2015 | AN | RX | No | No | ⤷ 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 | 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 | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | RE36247 | ⤷ Try a Trial |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 6,750,237*PED | ⤷ Try a Trial |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 7,220,767*PED | ⤷ 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 | 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 |
|---|---|---|
| Canada | 3148812 | ⤷ Try a Trial |
| China | 114450002 | ⤷ Try a Trial |
| Australia | 2020323846 | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2023055457 | ⤷ Try a Trial |
| Mexico | 2022001139 | ⤷ Try a Trial |
| Canada | 2879383 | ⤷ 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 |
|---|---|---|---|---|
| 1411918 | C300537 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFOR IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
| 2957286 | 1990003-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721 |
| 0454511 | 24/1998 | Austria | ⤷ Try a Trial | PRODUCT NAME: ''IRBESARTAN'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE; NAT. REGISTRATION NO/DATE: EU/1/97/046/001 - EU/1/97/046/009 19970827; FIRST REGISTRATION: LI 5425002 19970815 |
| 1869025 | 18C0004 | France | ⤷ Try a Trial | PRODUCT NAME: BREXPIPRAZOLE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/18/1294 20180730 |
| 0740668 | PA2003001,C0740668 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TADALAFILUM ((6R,12AR)-2,3,6,7,12,12A-HEKSAHIDRO-2-METIL-6-(3,4-METILENDIOKSIFENIL)-PIRAZINO(2',1':6,1)PIRIDO(3,4-B)INDOL-1,4-DIONAS); REGISTRATION NO/DATE: 03/8034/3, 03/8035/3 20030328 |
| 0454511 | 98C0028 | Belgium | ⤷ Try a Trial | PRODUCT NAME: IRBESARTAN; NATL. REGISTRATION NO/DATE: EU/1/97/046/001 19970827; FIRST REGISTRATION: CH 54250 02 19970815 |
| >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.
