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 four hundred and one approved drugs.
There are twenty-two US patents protecting AMNEAL drugs. There are seven tentative approvals on AMNEAL drugs.
There are one hundred and thirty-six patent family members on AMNEAL drugs in thirty-one countries and eight hundred and thirty-five supplementary protection certificates in nineteen countries.
Summary for AMNEAL
| International Patents: | 136 |
| US Patents: | 22 |
| Tradenames: | 304 |
| Ingredients: | 294 |
| NDAs: | 401 |
| 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 Ny | REPREXAIN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 076642-004 | Oct 19, 2007 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
| Amneal Pharm | DEMECLOCYCLINE HYDROCHLORIDE | demeclocycline hydrochloride | TABLET;ORAL | 065425-001 | Feb 27, 2008 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Amneal Pharms Co | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 207482-003 | Jun 28, 2017 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Amneal Pharms | FELBAMATE | felbamate | TABLET;ORAL | 201680-002 | Sep 13, 2011 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Amneal | ESTRADIOL | estradiol | GEL;TRANSDERMAL | 216055-003 | Jul 12, 2024 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Amneal Pharms | CLINDAMYCIN PALMITATE HYDROCHLORIDE | clindamycin palmitate hydrochloride | FOR SOLUTION;ORAL | 203513-001 | Mar 13, 2014 | AA | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Amneal | LYVISPAH | baclofen | GRANULES;ORAL | 215422-001 | Nov 22, 2021 | RX | Yes | No | 11,491,125 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| >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 | 021450-003 | Sep 16, 2013 | 6,750,237*PED | ⤷ Subscribe |
| Amneal | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | RE36247 | ⤷ Subscribe |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 7,220,767*PED | ⤷ Subscribe |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 6,750,237*PED | ⤷ Subscribe |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-003 | Sep 16, 2013 | 7,220,767*PED | ⤷ Subscribe |
| Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 5,466,699*PED | ⤷ Subscribe |
| >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 |
|---|---|---|
| China | 101631548 | ⤷ Subscribe |
| European Patent Office | 3609472 | ⤷ Subscribe |
| Spain | 2928071 | ⤷ Subscribe |
| Spain | 2730678 | ⤷ Subscribe |
| Portugal | 1907382 | ⤷ Subscribe |
| Japan | 2022109907 | ⤷ Subscribe |
| Portugal | 3604299 | ⤷ Subscribe |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AMNEAL Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3043773 | 132021000000191 | Italy | ⤷ Subscribe | PRODUCT NAME: MOMETASONE O UN SUO SALE E OLOPATADINA O UN SUO SALE(RYALTRIS); AUTHORISATION NUMBER(S) AND DATE(S): 048499014, 048499026, 048499038, 20210726;140638, 20210426 |
| 0521471 | 03C0043 | France | ⤷ Subscribe | PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106 |
| 2603514 | 122019000027 | Germany | ⤷ Subscribe | PRODUCT NAME: KOMBINATION VON VABORBACTAM, ODER EIN SALZ ODER EIN HYDRAT DAVON, UND MEROPENEM, ODER EIN SALZ ODER EIN HYDRAT DAVON, INSBESONDERE MEROPENEMTRIHYDRAT; REGISTRATION NO/DATE: EU/1/18/1334 20181120 |
| 2137537 | 122014000069 | Germany | ⤷ Subscribe | PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 0443983 | C300445 | Netherlands | ⤷ Subscribe | PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016 |
| 1429780 | 13C0012 | France | ⤷ Subscribe | PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808 |
| 0443983 | 2007C/043 | Belgium | ⤷ Subscribe | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 |
| >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.
