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Last Updated: June 2, 2020

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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 thirty approved drugs.

There is one US patent protecting AMNEAL PHARMS LLC drugs.

There are five patent family members on AMNEAL PHARMS LLC drugs in five countries and seventy-six supplementary protection certificates in thirteen countries.

Summary for Amneal Pharms Llc
International Patents:5
US Patents:1
Tradenames:25
Ingredients:25
NDAs:30

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 DEXTROMETHORPHAN POLISTIREX dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 203133-001 Jul 28, 2017 OTC No No   Start Trial   Start Trial
Amneal Pharms Llc ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907-002 Dec 28, 2006 AB RX Yes No   Start Trial   Start Trial
Amneal Pharms Llc FENOFIBRATE fenofibrate TABLET;ORAL 209950-002 Mar 19, 2018 AB RX No No   Start Trial   Start Trial
Amneal Pharms Llc ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 211293-001 Feb 4, 2019 AB1 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
>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
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
0770388 PA2009004,C0770388 Lithuania   Start Trial PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0648494 SPC/GB01/037 United Kingdom   Start Trial PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313
0253310 SPC/GB95/010 United Kingdom   Start Trial PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
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:

Colorcon
Harvard Business School
McKinsey
Medtronic
Mallinckrodt
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.