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BRISDELLE Drug Profile
» See Plans and Pricing
When do Brisdelle patents expire, and when can generic versions of Brisdelle launch?
Brisdelle is a drug marketed by Sebela Ireland Ltd and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-four patent family members in thirty-six countries.
The generic ingredient in BRISDELLE is paroxetine mesylate. There are thirty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.
US ANDA Litigation and Generic Entry Outlook for Brisdelle
A generic version of BRISDELLE was approved as paroxetine mesylate by ACTAVIS LABS FL INC on June 20th, 2017.
Summary for BRISDELLE
| International Patents: | 84 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 13 |
| Clinical Trials: | 4 |
| Patent Applications: | 86 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BRISDELLE |
| Drug Sales Revenues: | Drug sales revenues for BRISDELLE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BRISDELLE |
| DailyMed Link: | BRISDELLE at DailyMed |
Recent Clinical Trials for BRISDELLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Noven Therapeutics | Phase 1 |
| Noven Therapeutics | Phase 3 |
| Noven Therapeutics | Phase 2 |
Pharmacology for BRISDELLE
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
Paragraph IV (Patent) Challenges for BRISDELLE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BRISDELLE | CAPSULE;ORAL | paroxetine mesylate | 204516 | 2014-04-07 |
US Patents and Regulatory Information for BRISDELLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sebela Ireland Ltd | BRISDELLE | paroxetine mesylate | CAPSULE;ORAL | 204516-001 | Jun 28, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Sebela Ireland Ltd | BRISDELLE | paroxetine mesylate | CAPSULE;ORAL | 204516-001 | Jun 28, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Sebela Ireland Ltd | BRISDELLE | paroxetine mesylate | CAPSULE;ORAL | 204516-001 | Jun 28, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Sebela Ireland Ltd | BRISDELLE | paroxetine mesylate | CAPSULE;ORAL | 204516-001 | Jun 28, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for BRISDELLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sebela Ireland Ltd | BRISDELLE | paroxetine mesylate | CAPSULE;ORAL | 204516-001 | Jun 28, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BRISDELLE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 5846717 | Start Trial |
| China | 101505759 | Start Trial |
| Slovenia | 0994872 | Start Trial |
| Slovenia | 2719385 | Start Trial |
| Spain | 2698207 | Start Trial |
| Czech Republic | 9904295 | Start Trial |
| Mexico | 2009001275 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
