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BRISDELLE Drug Patent Profile
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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.
DrugPatentWatch® 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 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 16 |
| Clinical Trials: | 4 |
| Patent Applications: | 201 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BRISDELLE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BRISDELLE |
| What excipients (inactive ingredients) are in BRISDELLE? | BRISDELLE excipients list |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for BRISDELLE
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
BRISDELLE is protected by four US patents.
Patents protecting BRISDELLE
Crystalline paroxetine methane sulfonate
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Method of treating thermoregulatory disfunction with paroxetine
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
Method of treating thermoregulatory dysfunction with paroxetine
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
Method of treating thermoregulatory dysfunction with paroxetine
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
| 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 | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | |
| Sebela Ireland Ltd | BRISDELLE | paroxetine mesylate | CAPSULE;ORAL | 204516-001 | Jun 28, 2013 | AB | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | ||
| Sebela Ireland Ltd | BRISDELLE | paroxetine mesylate | CAPSULE;ORAL | 204516-001 | Jun 28, 2013 | AB | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| >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 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BRISDELLE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 100543614 | ⤷ Try it Free |
| South Korea | 20150132888 | ⤷ Try it Free |
| Slovakia | 161999 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
