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Serving leading biopharmaceutical companies globally:

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Moodys
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Baxter
Dow

Last Updated: November 20, 2019

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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 sixty-five approved drugs.

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

There are five patent family members on AMNEAL PHARM drugs in five countries and four hundred and fifty-nine supplementary protection certificates in fifteen 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 Co PREGABALIN pregabalin CAPSULE;ORAL 209743-007 Jul 19, 2019 AB RX No No   Start Trial   Start Trial
Amneal Pharms Co ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 208850-004 Oct 16, 2018 DISCN No No   Start Trial   Start Trial
Amneal Pharms Ny NAPROXEN naproxen TABLET;ORAL 075927-003 Dec 18, 2001 AB RX No No   Start Trial   Start Trial
Amneal Pharms VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 079098-002 May 11, 2010 AB RX No No   Start Trial   Start Trial
Amneal Pharms MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205825-002 Oct 12, 2016 AB RX No No   Start Trial   Start Trial
Amneal Pharms Ny HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040746-001 Aug 25, 2006 AA RX No No   Start Trial   Start Trial
Amneal Pharms MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090041-002 Apr 10, 2015 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
Paragraph IV (Patent) Challenges for AMNEAL PHARM drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01

Supplementary Protection Certificates for Amneal Pharm Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 1290013-0 Sweden   Start Trial PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
2101777 CA 2016 00024 Denmark   Start Trial PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
1304992 PA2013025,C1304992 Lithuania   Start Trial PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
0166287 96C0032 Belgium   Start Trial PRODUCT NAME: PANTOPRAZOL. NATR. SESQUIHYDRAS PANTOPRAZOLE; NAT. REGISTRATION NO/DATE: 127 IS 98 F 3 19960222; FIRST REGISTRATION: SE 12131 19940506
0536515 300244 Netherlands   Start Trial PRODUCT: TIGECYCLINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX, IN HET BIJZONDER TIGECYCLINE; FIRST REGISTRATION, DATE: EU/1/06/336/001, 20060424
0719278 23/2003 Austria   Start Trial PRODUCT NAME: DUTASTERIDE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SOLVATES; NAT. REGISTRATION NO/DATE: 1-24844, 1-24845 20030217; FIRST REGISTRATION: SE 17871, 17872 20020719
0138504 SPC/GB04/009 United Kingdom   Start Trial PRODUCT NAME: FULVESTRANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/03/269/001 20040310
>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:

Express Scripts
McKinsey
Harvard Business School
Colorcon
Baxter
AstraZeneca

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