Nexplanon Patent Expiration

Nexplanon is a drug owned by Organon Usa Llc. It is protected by 4 US drug patents filed from 2014 to 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 28, 2030. Details of Nexplanon's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9757552 Applicator for inserting an implant
Jul, 2030

(5 years from now)

Active
US8722037 X-ray visible drug delivery device
Sep, 2027

(2 years from now)

Active
US10821277 Kit for and method of assembling an applicator for inserting an implant
May, 2027

(2 years from now)

Active
US8888745 Applicator for inserting an implant
Aug, 2026

(1 year, 10 months from now)

Active


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 Nexplanon's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 11 Apr, 2024 US10821277
Payment of Maintenance Fee, 8th Year, Large Entity 12 Apr, 2022 US8888745
Payment of Maintenance Fee, 8th Year, Large Entity 14 Oct, 2021 US8722037
Post Issue Communication - Certificate of Correction 19 Jan, 2021 US10821277
Email Notification 21 Dec, 2020 US10821277
Mail Pub Notice re 312 amendment 21 Dec, 2020 US10821277
POST ISSUE OTHER COMMUNICATION TO APPLICANT- CERTIFICATE OF CORRECTION 17 Dec, 2020 US10821277
Post Issue Communication - Certificate of Correction Denied 17 Dec, 2020 US10821277
Patent Issue Date Used in PTA Calculation 03 Nov, 2020 US10821277
Recordation of Patent Grant Mailed 03 Nov, 2020 US10821277


FDA has granted several exclusivities to Nexplanon. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nexplanon, 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 Nexplanon.

Exclusivity Information

Nexplanon holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Nexplanon's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) May 31, 2014

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Several oppositions have been filed on Nexplanon'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 Nexplanon's generic, the next section provides detailed information on ongoing and past EP oppositions related to Nexplanon patents.

Nexplanon's Oppositions Filed in EPO

Nexplanon has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 10, 2017, by Elkington And Fife Llp. This opposition was filed on patent number EP06707776A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP18182632A Jun, 2021 Consilient Health Limited Granted and Under Opposition
EP06707783A Apr, 2019 Holme Patent A/S Granted and Under Opposition
EP06707776A May, 2017 ELKINGTON AND FIFE LLP Opposition rejected


US patents provide insights into the exclusivity only within the United States, but Nexplanon 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 Nexplanon's family patents as well as insights into ongoing legal events on those patents.

Nexplanon's Family Patents

Nexplanon has patent protection in a total of 34 countries. It's US patent count contributes only to 6.9% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Nexplanon.

Family Patents

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Generic Launch

Generic Release Date:

Nexplanon's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 28, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Nexplanon Generics:

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

Alternative Brands for Nexplanon

Nexplanon which is used for contraception., has several other brand drugs in the same treatment category and using the same active ingredient (Etonogestrel). 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 Treatment Area
Apil
Taytulla Used for contraception.
Femcon Fe Used for contraception.
Lo Minastrin Fe Used for preventing pregnancy.
Minastrin 24 Fe Used for contraception.
Bayer Hlthcare
Yaz Used for contraception, prevention of pregnancy, and treating premenstrual dysphoric disorder in premenopausal females.
Beyaz Used for contraception, prevention of pregnancy, and treating mood changes and anxiety in women with PMDD who choose oral contraceptives.
Yasmin Used for contraception.
Natazia Used for preventing pregnancy and treating heavy menstrual bleeding in women who use oral contraceptives.
Safyral Used for preventing pregnancy and raising folate levels to reduce the risk of neural tube defects in pregnancy.
Evofem Inc
Phexxi used for contraception.
Organon
Implanon

(uses Etonogestrel)

Used for contraception.
Teva Branded Pharm
Quartette Used for contraception.
Seasonale Used for contraception in women.
Seasonique Used for preventing pregnancy in women using oral contraceptives.
Loseasonique Used for contraceptive purposes.
Loestrin 24 Fe Used for preventing pregnancy.
Wyeth Pharms Inc
Lybrel Used for contraception.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Etonogestrel. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Organon Usa Organon
Nuvaring






About Nexplanon

Nexplanon is a drug owned by Organon Usa Llc. It is used for contraception. Nexplanon uses Etonogestrel as an active ingredient. Nexplanon was launched by Organon in 2006.

Approval Date:

Nexplanon was approved by FDA for market use on 17 July, 2006.

Active Ingredient:

Nexplanon uses Etonogestrel as the active ingredient. Check out other Drugs and Companies using Etonogestrel ingredient

Treatment:

Nexplanon is used for contraception.

Dosage:

Nexplanon is available in implant form for implantation use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
68MG/IMPLANT IMPLANT Prescription IMPLANTATION