Last Updated: May 10, 2026

PROSTEP Drug Patent Profile


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When do Prostep patents expire, and what generic alternatives are available?

Prostep is a drug marketed by Aveva and is included in one NDA.

The generic ingredient in PROSTEP is nicotine. There are thirty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the nicotine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prostep

A generic version of PROSTEP was approved as nicotine by DIFGEN PHARMS on October 20th, 1997.

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Summary for PROSTEP
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 105
DailyMed Link:PROSTEP at DailyMed

US Patents and Regulatory Information for PROSTEP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aveva PROSTEP nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 019983-003 Dec 23, 1998 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aveva PROSTEP nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 019983-004 Dec 23, 1998 DISCN No No ⤷  Start Trial ⤷  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

International Patents for PROSTEP

See the table below for patents covering PROSTEP around the world.

Country Patent Number Title Estimated Expiration
Spain 2112241 ⤷  Start Trial
New Zealand 224426 NICOTINE MEDICAMENT FOR TREATING SMOKING WITHDRAWAL SYMPTOMS ⤷  Start Trial
Philippines 24437 METHOD FOR THE TREATMENT OF WITHDRAWAL SYMPTOMS ASSOCIATED WITH SMOKING CESSATION AND PREPARATIONS FOR USE IN SAID METHOD ⤷  Start Trial
Ireland 871119 ⤷  Start Trial
Japan S646216 THERAPY FOR ABSTINENCE SYMPTOM RELATED TO NO SMOKING AND MEDICINE THEREFOR ⤷  Start Trial
Germany 3856096 ⤷  Start Trial
Norway 179963 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

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