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Last Updated: June 23, 2024

XULANE Drug Patent Profile


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When do Xulane patents expire, and when can generic versions of Xulane launch?

Xulane is a drug marketed by Mylan Technologies and is included in one NDA.

The generic ingredient in XULANE is ethinyl estradiol; norelgestromin. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.

Drug patent expirations by year for XULANE
Drug Prices for XULANE

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Drug Sales Revenue Trends for XULANE

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Recent Clinical Trials for XULANE

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

SponsorPhase
Noven Pharmaceuticals, Inc.Phase 1
Purdue UniversityPhase 4
Massachusetts General HospitalPhase 4

See all XULANE clinical trials

Pharmacology for XULANE
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen Receptor Agonists

US Patents and Regulatory Information for XULANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Technologies XULANE ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 200910-001 Apr 16, 2014 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for XULANE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gedeon Richter Plc. Evra norelgestromin, ethinyl estradiol EMEA/H/C/000410
Female contraception.Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.
Authorised no no no 2002-08-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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