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 eight tentative approvals on AMNEAL drugs.
There are sixteen patent family members on AMNEAL drugs in twelve countries and eight hundred and three 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 Pharms | BENAZEPRIL HYDROCHLORIDE | benazepril hydrochloride | TABLET;ORAL | 076820-001 | Feb 3, 2006 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal | POTASSIUM CHLORIDE | potassium chloride | SOLUTION;ORAL | 210041-001 | Jul 19, 2018 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal Pharms Co | CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE;ORAL | 208632-003 | Oct 31, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal Pharms | VALSARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; valsartan | TABLET;ORAL | 204382-005 | Aug 11, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal Pharms Ny | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | cetirizine hydrochloride | TABLET;ORAL | 078780-003 | Jan 21, 2010 | OTC | 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 | 021450-004 | Sep 30, 2003 | 5,466,699*PED | ⤷ Sign Up |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-003 | Sep 16, 2013 | 6,750,237*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 | 6,750,237*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 | 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 |
| ➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
International Patents for Amneal Drugs
Supplementary Protection Certificates for Amneal Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0503785 | 20/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, MIT AMLODIPINBESILAT; NAT. REGISTRATION NO/DATE: 1-27894, 1-27895, 1-27896 20081217; FIRST REGISTRATION: NL 100989, 100990, 100991 20080819 |
| 1411918 | PA2012011,C1411918 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
| 1214076 | 49/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 2487162 | 2016/063 | Ireland | ⤷ Sign Up | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE; REGISTRATION NO/DATE: EU/1/14/967 20141119 |
| 2139494 | 122020000043 | Germany | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715 |
| >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.
