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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Xulane
A generic version of XULANE was approved as ethinyl estradiol; norelgestromin by AMNEAL on February 25th, 2021.
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Questions you can ask:
- What is the 5 year forecast for XULANE?
- What are the global sales for XULANE?
- What is Average Wholesale Price for XULANE?
Summary for XULANE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 2 |
| Drug Prices: | Drug price information for XULANE |
| Drug Sales Revenues: | Drug sales revenues for XULANE |
| DailyMed Link: | XULANE at DailyMed |
Recent Clinical Trials for XULANE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Noven Pharmaceuticals, Inc. | Phase 1 |
| Massachusetts General Hospital | Phase 4 |
| Penn State University | Phase 4 |
Pharmacology for XULANE
| Drug Class | Estrogen Progestin |
| Mechanism of Action | Estrogen 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 |
