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 Co | EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 208831-004 | Nov 21, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms | ESTRADIOL | estradiol | TABLET;VAGINAL | 205256-001 | May 29, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal | SIROLIMUS | sirolimus | SOLUTION;ORAL | 211212-001 | Oct 18, 2019 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal | LYVISPAH | baclofen | GRANULES;ORAL | 215422-001 | Nov 22, 2021 | RX | Yes | No | 10,792,262 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Amneal Pharm | BETHANECHOL CHLORIDE | bethanechol chloride | TABLET;ORAL | 040855-004 | Nov 21, 2007 | AA | 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 |
| >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 | 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 |
| ➤ Subscribe | Nasal Spray | 2.5 mg/spray | ➤ Subscribe | 2016-06-09 |
| ➤ Subscribe | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
International Patents for AMNEAL Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 4003323 | ⤷ Try a Trial |
| Canada | 3148812 | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2023055457 | ⤷ Try a Trial |
| Mexico | 2022001139 | ⤷ Try a Trial |
| Russian Federation | 2015100116 | ⤷ 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 |
|---|---|---|---|---|
| 1280520 | C01280520/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012 |
| 0810209 | SZ 33/2007 | Austria | ⤷ Try a Trial | PRODUCT NAME: DARUNAVIR UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE |
| 1411918 | 122012000044 | Germany | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFOR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER EIN METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
| 0316704 | 2001C/021 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CAPECITABINE, NATL REGISTRATION NO/DATE: EU/1/00/163/001 20010205; FIRST REGISTRATION: CH 54657 19980610 |
| 0463756 | SPC/GB99/004 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: SILDENAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE CITRATE SALT; REGISTERED: CH 54642 19980622; UK EU/1/98/077/001 19980914; UK EU/1/98/077/002 19980914; UK EU/1/98/077/003 19980914; UK EU/1/98/077/004 19980914; UK EU/1/98/077/005 19980914; UK EU/1/98/077/006 19980914; UK EU/1/98/077/007 19980914; UK EU/1/98/077/008 19980914; UK EU/1/98/077/009 19980914; UK EU/1/98/077/010 19980914; UK EU/1/98/077/011 19980914; UK EU/1/98/077/012 19980914 |
| >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.
