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Ozempic Patent Expiration

What is Ozempic?

Ozempic (semaglutide) is an injectable medication used to improve blood sugar levels in adults with type 2 diabetes. It belongs to a class of drugs called GLP-1 receptor agonists and works by mimicking the effects of the hormone GLP-1, which helps regulate blood sugar levels. Ozempic slows digestion and decreases appetite, leading to improved glycemic control and potential weight loss benefits.

What is the Ozempic controversy?

The injectable diabetes medication Ozempic (semaglutide) has recently seen its FDA-approved label updated to warn of potential serious intestinal side effects like obstruction or blockage. The newly added FDA warning highlights that Ozempic may cause severe gastrointestinal issues like intestinal obstruction, intense abdominal pain, vomiting, constipation, and abdominal swelling.

Ozempic Patent Details

Ozempic is a drug owned by Novo Nordisk Inc. It is protected by 25 US drug patents filed from 2018 to 2022. Out of these, 20 drug patents are active and 5 have expired. Ozempic's patents have been open to challenges since 05 December, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 21, 2033. Details of Ozempic's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US8129343 Acylated GLP-1 compounds
Dec, 2031

(7 years from now)

Active
US8536122 Acylated GLP-1 compounds
Mar, 2026

(1 year, 5 months from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10335462 Use of long-acting GLP-1 peptides
Jun, 2033

(8 years from now)

Active
US9132239 Dial-down mechanism for wind-up pen
Feb, 2032

(7 years from now)

Active
US9457154 Injection device with an end of dose feedback mechanism
Sep, 2027

(2 years from now)

Active
US9687611 Injection device with torsion spring and rotatable display
Feb, 2027

(2 years from now)

Active
USRE46363 Dial-down mechanism for wind-up pen
Aug, 2026

(1 year, 9 months from now)

Active
US9775953 Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Jul, 2026

(1 year, 9 months from now)

Active
US11097063 Syringe device with a dose limiting mechanism and an additional safety mechanism
Jul, 2026

(1 year, 9 months from now)

Active
US10220155 Syringe device with a dose limiting mechanism and an additional safety mechanism
Jul, 2026

(1 year, 9 months from now)

Active
US8920383 Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Jul, 2026

(1 year, 9 months from now)

Active
US9108002 Automatic injection device with a top release mechanism
Jan, 2026

(1 year, 3 months from now)

Active
US10357616 Injection device with an end of dose feedback mechanism
Jan, 2026

(1 year, 3 months from now)

Active
US10376652 Automatic injection device with a top release mechanism
Jan, 2026

(1 year, 3 months from now)

Active
US9861757 Injection device with an end of dose feedback mechanism
Jan, 2026

(1 year, 3 months from now)

Active
US9616180 Automatic injection device with a top release mechanism
Jan, 2026

(1 year, 3 months from now)

Active
US11311679 Automatic injection device with a top release mechanism
Jan, 2026

(1 year, 3 months from now)

Active
US8684969 Injection device with torsion spring and rotatable display
Oct, 2025

(1 year, 8 days from now)

Active
US11446443 Injection device with torsion spring and rotatable display
Oct, 2025

(1 year, 8 days from now)

Active
US8114833 Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Aug, 2025

(10 months from now)

Active
US7762994 Needle mounting system and a method for mounting a needle assembly
May, 2024

(4 months ago)

Expired
US8579869 Needle mounting system and a method for mounting a needle assembly
Jun, 2023

(1 year, 3 months ago)

Expired
US9486588 Automatic injection device with reset feature
Jan, 2022

(2 years ago)

Expired
US6899699 Automatic injection device with reset feature
Jan, 2022

(2 years ago)

Expired
US8672898 Automatic injection device with reset feature
Jan, 2022

(2 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Ozempic's patents.

Given below is the list of recent legal activities going on the following patents of Ozempic.

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 01 Jul, 2024 US9486588
Request for Trial Granted 28 May, 2024 US10335462
Request for Trial Granted 25 Apr, 2024 US10335462
Payment of Maintenance Fee, 8th Year, Large Entity 21 Mar, 2024 US9457154
Petition Requesting Trial 12 Mar, 2024 US10335462
Petition Requesting Trial 29 Nov, 2023 US10335462
Petition Requesting Trial 26 Oct, 2023 US10335462
Request for Trial Granted 04 Oct, 2023 US10335462
Request for Trial Denied 02 Oct, 2023 US8129343 (Litigated)
Request for Trial Denied 02 Oct, 2023 US8536122 (Litigated)


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Ozempic and ongoing litigations to help you estimate the early arrival of Ozempic generic.

Ozempic's Litigations

Ozempic been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 22, 2020, against patent number US8114833. The petitioner Pfizer Inc., challenged the validity of this patent, with Novo Nordisk A/S as the respondent. Click below to track the latest information on how companies are challenging Ozempic's patents.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10335462 March, 2024 Pending Novo Nordisk A/S Apotex Inc. et al.
US10335462 November, 2023 Trial Instituted
(28 May, 2024)
Novo Nordisk A/S Sun Pharmaceutical Industries Ltd. et al.
US10335462 October, 2023 Trial Instituted
(25 Apr, 2024)
Novo Nordisk A/S DR. REDDY'S LABORATORIES, INC. et al.
US10335462 March, 2023 Trial Instituted
(04 Oct, 2023)
Novo Nordisk A/S Mylan Pharmaceuticals Inc. et al.
US8129343 March, 2023 Institution Denied
(02 Oct, 2023)
Novo Nordisk A/S Mylan Pharmaceuticals Inc. et al.
US8536122 March, 2023 Institution Denied
(02 Oct, 2023)
Novo Nordisk A/S Mylan Pharmaceuticals Inc. et al.
US8114833 March, 2022 Terminated-Settled
(08 Sep, 2022)
Novo Nordisk A/S Fresenius Kabi USA, LLC
US8114833 December, 2019 Terminated-Settled
(21 Jun, 2021)
Novo Nordisk A/S et al. Pfizer Inc. et al.
US8114833 July, 2020 Terminated-Settled
(21 Jun, 2021)
Novo Nordisk A/S Pfizer Inc.


FDA has granted some exclusivities to Ozempic. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ozempic, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Ozempic.

Exclusivity Information

Ozempic holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Ozempic's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 05, 2022
New Indication(I-822) Jan 16, 2023
New Dosing Schedule(D-185) Mar 28, 2025

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Several oppositions have been filed on Ozempic's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Ozempic's generic, the next section provides detailed information on ongoing and past EP oppositions related to Ozempic patents.

Ozempic's Oppositions Filed in EPO

Ozempic has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 23, 2006, by Owen Mumford Limited. This opposition was filed on patent number EP02726984A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP02726984A NA Genentech, Inc. Patent maintained as amended
EP13737808A Jan, 2021 Galenicum Health S.L.U. Granted and Under Opposition
EP13737808A Jan, 2021 Teva Pharmaceutical Industries LTD. Granted and Under Opposition
EP13737808A Jan, 2021 Generics [UK] Limited Granted and Under Opposition
EP17196501A Dec, 2019 Hoffmann Eitle Granted and Under Opposition
EP17196501A Dec, 2019 Generics (U.K.) Limited Granted and Under Opposition
EP17196501A Dec, 2019 Dr. Reddy's Laboratories Limited Granted and Under Opposition
EP17196501A Dec, 2019 Galenicum Health S.L.U. Granted and Under Opposition
EP17196501A Dec, 2019 Teva Pharmaceutical Industries Ltd Granted and Under Opposition
EP04797453A Aug, 2018 Uexküll & Stolberg Partnerschaft von Patent- und Rechtsanwälten mbB Opposition rejected
EP04797453A Aug, 2018 Wittkopp, Alexander Opposition rejected
EP04797453A Aug, 2018 Generics (U.K.) Limited Opposition rejected
EP04797453A Aug, 2018 Teva Pharmaceutical Industries Ltd Opposition rejected
EP04797453A Aug, 2018 Fresenius Kabi Deutschland GmbH Opposition rejected
EP04797453A Aug, 2018 Sandoz AG Opposition rejected
EP06701034A Jan, 2018 Schwöbel, Thilo Opposition rejected
EP06754730A Dec, 2011 Ypsomed AG Patent maintained as amended
EP06754730A Nov, 2011 WMC Matthes Consulting Patent maintained as amended
EP06725149A May, 2011 AMYLIN PHARMACEUTICALS, INC. Opposition rejected
EP06762643A Jul, 2010 Sanofi-Aventis Deutschland GmbH Patent maintained as amended
EP05796880A Jul, 2010 Ypsomed AG Granted and Under Opposition
EP05796880A Jul, 2010 Stöckeler, Ferdinand Granted and Under Opposition
EP05796880A Jul, 2010 OWEN MUMFORD LIMITED Granted and Under Opposition
EP05796880A Jul, 2010 Ferring International Center S.A. Granted and Under Opposition
EP05796880A Jul, 2010 COPERNICUS sp. zo.o. Granted and Under Opposition
EP05796880A Jul, 2010 Genentech, Inc. Granted and Under Opposition
EP06121820A May, 2010 SANOFI-AVENTIS DEUTSCHLAND GMBH Opposition rejected
EP02726984A Mar, 2006 TecPharma Licensing AG Patent maintained as amended
EP02726984A Feb, 2006 OWEN MUMFORD LIMITED Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Ozempic is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Ozempic's family patents as well as insights into ongoing legal events on those patents.

Ozempic's Family Patents

Ozempic has patent protection in a total of 28 countries. It's US patent count contributes only to 22.7% of its total global patent coverage. Click below to unlock the full patent family tree for Ozempic.

Family Patents

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Clinical Trials

Recent Clinical Trials on Ozempic:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Ozempic(Semaglutide) has 5 clinical trials that have been verified in 2024. Out of these 5, 1 trial is in PHASE4.

Title Lead Sponsor Collaborators Status Phases
A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes Novo Nordisk A/S RECRUITING
(Sep, 2024)
PHASE3
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Finland, as Part of Local Clinical Practice Novo Nordisk A/S COMPLETED
(Sep, 2024)
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in Chinese Adults Who Are Above a Healthy Weight Range (OASIS 3) Novo Nordisk A/S ACTIVE NOT RECRUITING
(Sep, 2024)
PHASE3
Semaglutide Treatment for Hyperglycaemia After Renal Transplantation Rigshospitalet, Denmark Aarhus University Hospital, Odense University Hospital RECRUITING
(Jun, 2024)
PHASE4
Semaglutide in CFRD University of Minnesota Cystic Fibrosis Foundation RECRUITING
(Jun, 2024)
PHASE2, PHASE3
A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy Novo Nordisk A/S ENROLLING BY INVITATION
(Oct, 2023)
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Novo Nordisk A/S COMPLETED
(Jun, 2023)
PHASE1
Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes Novo Nordisk A/S COMPLETED
(Jul, 2022)
PHASE3
Real-world Health Outcomes in Canadian Patients Using Semaglutide LMC Diabetes & Endocrinology Ltd. COMPLETED
(Feb, 2020)
A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes Novo Nordisk A/S COMPLETED
(Aug, 2018)
PHASE1




Generic Launch

Generic Release Date:

Ozempic's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 21, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Ozempic Generics:

There are no approved generic versions for Ozempic as of now.

How can I launch a generic of Ozempic before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Ozempic's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ozempic's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Ozempic -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
2 mg/1.5 mL and 4 mg/3 mL 06 Dec, 2021 7 21 Jun, 2033
8 mg/3 mL 21 Dec, 2022 1 01 Feb, 2032

Alternative Brands for Ozempic

Ozempic which is used for treating Type 2 diabetes as an adjunct to diet and exercise to improve glycemic control in adults., has several other brand drugs using the same active ingredient (Semaglutide). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Novo
Rybelsus
Wegovy






About Ozempic

Ozempic is a drug owned by Novo Nordisk Inc. It is used for treating Type 2 diabetes as an adjunct to diet and exercise to improve glycemic control in adults. Ozempic uses Semaglutide as an active ingredient. Ozempic was launched by Novo in 2017.

Approval Date:

Ozempic was approved by FDA for market use on 05 December, 2017.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Ozempic is 05 December, 2017, its NCE-1 date is estimated to be 05 December, 2021.

Active Ingredient:

Ozempic uses Semaglutide as the active ingredient. Check out other Drugs and Companies using Semaglutide ingredient

Treatment:

Ozempic is used for treating Type 2 diabetes as an adjunct to diet and exercise to improve glycemic control in adults.

Dosage:

Ozempic is available in solution form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
2MG/3ML (0.68MG/ML) SOLUTION Prescription SUBCUTANEOUS
2MG/1.5ML (1.34MG/ML) SOLUTION Prescription SUBCUTANEOUS
4MG/3ML (1.34MG/ML) SOLUTION Prescription SUBCUTANEOUS
8MG/3ML (2.68MG/ML) SOLUTION Prescription SUBCUTANEOUS


Ozempic News

Information on Ozempic and Wegovy, prescription medications for weight loss: A comprehensive guide - Quartz

09 Oct, 2024

Novo Nordisk resolves legal dispute with Viatris in the US regarding Ozempic and Wegovy

07 Oct, 2024

Novo Nordisk and Viatris reach agreement in patent dispute over weight-loss medications

07 Oct, 2024

The US Department of Health and Human Services announces cost savings for 54 prescription medications, including Novartis' cancer treatment...

01 Oct, 2024

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