JALYN Drug Patent Profile
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Which patents cover Jalyn, and when can generic versions of Jalyn launch?
Jalyn is a drug marketed by Waylis Therap and is included in one NDA.
The generic ingredient in JALYN is dutasteride; tamsulosin hydrochloride. There are eighteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Jalyn
A generic version of JALYN was approved as dutasteride; tamsulosin hydrochloride by ENDO OPERATIONS on February 26th, 2014.
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Summary for JALYN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Patent Applications: | 11 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for JALYN |
| What excipients (inactive ingredients) are in JALYN? | JALYN excipients list |
| DailyMed Link: | JALYN at DailyMed |
Paragraph IV (Patent) Challenges for JALYN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| JALYN | Capsules | dutasteride; tamsulosin hydrochloride | 0.5 mg/0.4 mg | 022460 | 1 | 2010-10-26 |
US Patents and Regulatory Information for JALYN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Waylis Therap | JALYN | dutasteride; tamsulosin hydrochloride | CAPSULE;ORAL | 022460-001 | Jun 14, 2010 | AB | RX | Yes | 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 |
Expired US Patents for JALYN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Waylis Therap | JALYN | dutasteride; tamsulosin hydrochloride | CAPSULE;ORAL | 022460-001 | Jun 14, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Waylis Therap | JALYN | dutasteride; tamsulosin hydrochloride | CAPSULE;ORAL | 022460-001 | Jun 14, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Waylis Therap | JALYN | dutasteride; tamsulosin hydrochloride | CAPSULE;ORAL | 022460-001 | Jun 14, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for JALYN
See the table below for patents covering JALYN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Finland | 961232 | ⤷ Sign Up | |
| African Regional IP Organization (ARIPO) | 9400669 | ⤷ Sign Up | |
| Germany | 69407978 | ⤷ Sign Up | |
| Luxembourg | 91027 | ⤷ Sign Up | |
| Hungary | 9600643 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JALYN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0719278 | SPC/GB03/018 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: DUTASTERIDE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SOLVATE.; REGISTERED: SE 17871 20020719; SE 17872 20020719; UK PL 19494/0005 20030117; UK PL 19494/0006 20030117 |
| 0719278 | PA 2003 007, C 0719278 /L | Lithuania | ⤷ Sign Up | |
| 0719278 | SPC009/2005 | Ireland | ⤷ Sign Up | SPC009/2005: 20060316, EXPIRES: 20170718 |
| 0719278 | C300122 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DUTASTERIDUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT; NAT. REGISTRATION NO/DATE: RVG 28317RVG 28318 2002161216; FIRST REGISTRATION: 1787117872 2002190719 |
| 0719278 | 300122 | Netherlands | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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