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Last Updated: June 5, 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-eight approved drugs.

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

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

Summary for Amneal Pharms
International Patents:5
US Patents:1
Tradenames:186
Ingredients:181
NDAs:238

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 CELECOXIB celecoxib CAPSULE;ORAL 208833-004 May 31, 2018 AB RX 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 CELECOXIB celecoxib CAPSULE;ORAL 208833-002 May 31, 2018 AB RX No No   Start Trial   Start Trial
Amneal Pharms Llc MESALAMINE mesalamine SUPPOSITORY;RECTAL 210509-001 Jan 2, 2020 AB RX No No   Start Trial   Start Trial
Amneal Pharms DUTASTERIDE dutasteride CAPSULE;ORAL 203118-001 Nov 20, 2015 AB RX No No   Start Trial   Start Trial
Amneal Pharms Ny HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 076642-001 Oct 12, 2004 AB RX No Yes   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 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
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24

Supplementary Protection Certificates for Amneal Pharms Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1539166 CR 2013 00059 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1730131 C01730131/02 Switzerland   Start Trial PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
0641330 CR 2004 00036 Denmark   Start Trial PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
1412357 122008000046 Germany   Start Trial PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
0113964 97C0037 Belgium   Start Trial PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
1453521 132016000025143 Italy   Start Trial PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
>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
Mallinckrodt
Moodys
Medtronic
Johnson and Johnson
Colorcon

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.