Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 14, 2019

DrugPatentWatch Database Preview

OZEMPIC Drug Profile

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Which patents cover Ozempic, and when can generic versions of Ozempic launch?

Ozempic is a drug marketed by Novo and is included in one NDA. There are twenty-one patents protecting this drug.

This drug has two hundred and sixteen patent family members in twenty-four countries.

The generic ingredient in OZEMPIC is semaglutide. Two suppliers are listed for this compound. Additional details are available on the semaglutide profile page.

Drug patent expirations by year for OZEMPIC
Drug Prices for OZEMPIC

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Generic Entry Opportunity Date for OZEMPIC
Generic Entry Date for OZEMPIC*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OZEMPIC

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2
Case Western Reserve UniversityPhase 2
Medical University of South CarolinaPhase 2

See all OZEMPIC clinical trials

Recent Litigation for OZEMPIC

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-03
SMITH v. NOVO NORDISK INC.2016-08-08

See all OZEMPIC litigation

Synonyms for OZEMPIC
53AXN4NNHX
910463-68-2
910463-93-3
EX-A2424
GTPL9724
NN 9535
NN-9535
NN9535
NNC 0113-0217
Semaglutide
Semaglutide [USAN:INN]
Sermaglutide
UNII-53AXN4NNHX

US Patents and Regulatory Information for OZEMPIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 RX Yes Yes   See Pricing   See Pricing Y Y   See Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for OZEMPIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1863839 18C1017 France   See Pricing PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839 1890018-3 Sweden   See Pricing PRODUCT NAME: SEMAGLUTIDE; REG. NO/DATE: EU/1/17/1251 20180212
1863839 2018C/016 Belgium   See Pricing PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verifification 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.