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Last Updated: August 4, 2020

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Amneal Pharm Company Profile

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What is the competitive landscape for AMNEAL PHARM, and when can generic versions of AMNEAL PHARM drugs launch?

AMNEAL PHARM has two hundred and forty-seven approved drugs.

There is one US patent protecting AMNEAL PHARM drugs. There are eleven tentative approvals on AMNEAL PHARM drugs.

There are five patent family members on AMNEAL PHARM drugs in six countries and four hundred and forty-six supplementary protection certificates in sixteen countries.

Summary for Amneal Pharm

Drugs and US Patents for Amneal Pharm

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 IBUPROFEN ibuprofen TABLET;ORAL 071334-001 Nov 25, 1986 AB RX No No   Start Trial   Start Trial
Amneal Pharms PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040902-001 Aug 25, 2009 AA RX No No   Start Trial   Start Trial
Amneal Pharms Ny CETIRIZINE HYDROCHLORIDE HIVES RELIEF cetirizine hydrochloride TABLET;ORAL 078780-002 Jan 21, 2010 OTC 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
Paragraph IV (Patent) Challenges for AMNEAL PHARM drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14

Supplementary Protection Certificates for Amneal Pharm Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 PA2008013 Lithuania   Start Trial PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
2957286 132019000000021 Italy   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721
0480717 98C0022 France   Start Trial PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
>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.

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Express Scripts
AstraZeneca
Boehringer Ingelheim
McKinsey

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