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Last Updated: January 26, 2020

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Amneal Pharms Company Profile

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

AMNEAL PHARMS has two hundred and thirty-six approved drugs.

There is one US patent protecting AMNEAL PHARMS drugs. There are thirteen tentative approvals on AMNEAL PHARMS drugs.

There are five patent family members on AMNEAL PHARMS drugs in five countries and four hundred and twenty-three supplementary protection certificates in fifteen countries.

Summary for Amneal Pharms
International Patents:5
US Patents:1
Tradenames:183
Ingredients:178
NDAs:236

Drugs and US Patents for Amneal Pharms

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 ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 208850-004 Oct 16, 2018 DISCN No No   Start Trial   Start Trial
Amneal Pharms Llc LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 210831-006 Feb 19, 2019 DISCN No No   Start Trial   Start Trial
Amneal Pharms Ny IBUPROFEN ibuprofen TABLET;ORAL 071334-001 Nov 25, 1986 AB RX No No   Start Trial   Start Trial
Amneal Pharms Co ETODOLAC etodolac TABLET;ORAL 208834-001 Jun 7, 2018 AB RX No No   Start Trial   Start Trial
Amneal Pharms Ny NAPROXEN SODIUM naproxen sodium TABLET;ORAL 079096-001 Dec 16, 2008 OTC No No   Start Trial   Start Trial
Amneal Pharms EXEMESTANE exemestane TABLET;ORAL 206421-001 Dec 28, 2018 DISCN No No   Start Trial   Start Trial
Amneal Pharms WARFARIN SODIUM warfarin sodium TABLET;ORAL 202202-004 Mar 4, 2013 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 PHARMS 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 Pharms Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0717738 02C0005 France   Start Trial PRODUCT NAME: LINEZOLIDE; NAT. REGISTRATION NO/DATE: NL 26 660 20010831; FIRST REGISTRATION: GB - PL 00 32/0261 20010105
0548114 SPC/GB97/064 United Kingdom   Start Trial PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
0801067 C00801067/01 Switzerland   Start Trial PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006
1214076 C01214076/01 Switzerland   Start Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0933372 PA2008006,C0933372 Lithuania   Start Trial PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
1411900 SPC/GB11/015 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1506211 300677 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
>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:

AstraZeneca
Merck
McKinsey
McKesson
Boehringer Ingelheim
Express Scripts

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