DrugPatentWatch Database Preview
Amneal Company Profile
Email this page to a colleague
See Plans and PricingWhat is the competitive landscape for AMNEAL, and what generic alternatives to AMNEAL drugs are available?
AMNEAL has two hundred and seventy-five approved drugs.
There is one US patent protecting AMNEAL drugs. There are thirteen tentative approvals on AMNEAL drugs.
There are five patent family members on AMNEAL drugs in five countries and four hundred and ninety-four supplementary protection certificates in sixteen countries.
Summary for Amneal
| International Patents: | 5 |
| US Patents: | 1 |
| Tradenames: | 219 |
| Ingredients: | 213 |
| NDAs: | 275 |
| 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 | MEROPENEM | meropenem | INJECTABLE;INJECTION | 205883-002 | Apr 12, 2016 | AP | RX | No | No | Start Trial | Start Trial | ||||
| Amneal | FULVESTRANT | fulvestrant | INJECTABLE;INTRAMUSCULAR | 210044-001 | Mar 4, 2019 | AO | RX | No | No | Start Trial | Start Trial | ||||
| Amneal Pharms Ny | IBUPROFEN | ibuprofen | TABLET;ORAL | 072199-001 | May 23, 1988 | OTC | No | No | Start Trial | Start Trial | |||||
| Amneal Pharms | ESCITALOPRAM OXALATE | escitalopram oxalate | TABLET;ORAL | 205619-002 | May 17, 2017 | AB | RX | No | No | Start Trial | Start Trial | ||||
| Amneal Pharms | MILNACIPRAN HYDROCHLORIDE | milnacipran hydrochloride | TABLET;ORAL | 205081-004 | Apr 22, 2016 | DISCN | No | No | Start Trial | Start Trial | |||||
| Amneal Pharms Co | ERYTHROMYCIN | erythromycin | TABLET;ORAL | 209720-001 | Mar 9, 2018 | AB | RX | No | No | Start Trial | Start Trial | ||||
| Amneal Pharms Llc | MESALAMINE | mesalamine | SUPPOSITORY;RECTAL | 210509-001 | Jan 2, 2020 | AB | RX | No | No | Start Trial | Start 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 Pharms Llc | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | RE36247 | Start 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 | for Injection | 100 mcg/vial and 500 mcg/vial | ➤ Subscribe | 2015-04-14 |
| ➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
| ➤ Subscribe | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
| ➤ 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) | 2013139179 | Start Trial |
| Russian Federation | 2015100116 | Start Trial |
| China | 103315947 | Start Trial |
| European Patent Office | 2881109 | Start Trial |
| Canada | 2879383 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amneal Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1412357 | CA 2008 00035 | Denmark | Start Trial | PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID |
| 0166287 | SPC/GB96/056 | United Kingdom | Start Trial | PRODUCT NAME: PANTOPRAZOLE AND ITS SALTS, HYDRATES AND HYDRATES OF ITS SALTS; REGISTERED: SE SE12131 19940506; UK 04889/0010 19960604 |
| 2932970 | 1890039-9 | Sweden | Start Trial | PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518 |
| 0720599 | SPC/GB05/010 | United Kingdom | Start Trial | PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411 |
| 0770388 | SPC/GB09/026 | United Kingdom | Start Trial | PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208 |
| 0579826 | 02C0041 | France | Start Trial | PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418 |
| 1214076 | SZ 49/2008 | Austria | Start Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON |
| >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.
