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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
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McKinsey
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Last Updated: October 20, 2019

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Amneal Pharms Llc Company Profile

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What is the competitive landscape for AMNEAL PHARMS LLC, and what generic alternatives to AMNEAL PHARMS LLC drugs are available?

AMNEAL PHARMS LLC has twenty-three approved drugs.

There is one US patent protecting AMNEAL PHARMS LLC drugs. There is one tentative approval on AMNEAL PHARMS LLC drugs.

There are five patent family members on AMNEAL PHARMS LLC drugs in five countries and fifty-nine supplementary protection certificates in twelve countries.

Summary for Amneal Pharms Llc
International Patents:5
US Patents:1
Tradenames:18
Ingredients:18
NDAs:23

Drugs and US Patents for Amneal Pharms Llc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Llc CLOBETASOL PROPIONATE clobetasol propionate OINTMENT;TOPICAL 210551-001 Aug 21, 2018 DISCN No No   Start Trial   Start Trial
Amneal Pharms Llc LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 210831-010 Feb 19, 2019 DISCN No No   Start Trial   Start Trial
Amneal Pharms Llc AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 205666-001 Jul 19, 2018 AB RX No No   Start Trial   Start Trial
Amneal Pharms Llc ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 211293-002 Feb 4, 2019 AB1 RX No No   Start Trial   Start Trial
Amneal Pharms Llc ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 211293-005 Feb 4, 2019 AB1 RX No No   Start Trial   Start Trial
Amneal Pharms Llc LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 210831-007 Feb 19, 2019 DISCN 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 LLC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01

Supplementary Protection Certificates for Amneal Pharms Llc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 SPC/GB08/020 United Kingdom   Start Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/020 GRANTED TO ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. IN RESPECT OF THE PRODUCT RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6346 DATED 05 JANUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 JANUARY 2023.
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1539166 92323 Luxembourg   Start Trial PRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624
1499331 SPC/GB13/034 United Kingdom   Start Trial PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
0398460 C300221 Netherlands   Start Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0733366 SPC/GB98/031 United Kingdom   Start Trial PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
>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:

Merck
Dow
Harvard Business School
Express Scripts
AstraZeneca
Boehringer Ingelheim

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