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: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 17 |
| Clinical Trials: | 4 |
| Patent Applications: | 207 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for BRISDELLE
Paragraph IV (Patent) Challenges for BRISDELLE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BRISDELLE | Capsules | paroxetine mesylate | 7.5 mg | 204516 | 1 | 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Method of treating thermoregulatory disfunction with paroxetine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
Method of treating thermoregulatory dysfunction with paroxetine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
Method of treating thermoregulatory dysfunction with paroxetine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | |
| Sebela Ireland Ltd | BRISDELLE | paroxetine mesylate | CAPSULE;ORAL | 204516-001 | Jun 28, 2013 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Sebela Ireland Ltd | BRISDELLE | paroxetine mesylate | CAPSULE;ORAL | 204516-001 | Jun 28, 2013 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| >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 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BRISDELLE
See the table below for patents covering BRISDELLE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Iceland | 7098 | See Plans and Pricing | |
| China | 101505759 | Method of treating thermoregulatory disfunction with paroxetine | See Plans and Pricing |
| Hungary | E040099 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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