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Generated: July 23, 2017
What are the generic drug sources for linaclotide and what is the scope of linaclotide freedom to operate?
Linaclotide is the generic ingredient in one branded drug marketed by Forest Labs Llc and is included in one NDA. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 9 |
| Suppliers / Packagers: see list | 3 |
| Bulk Api Vendors: see list | 7 |
| Clinical Trials: see list | 29 |
| Patent Applications: see list | 24 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | linaclotide at DailyMed |
| Drug Class | Guanylate Cyclase-C Agonist |
| Mechanism of Action | Guanylate Cyclase Activators |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Forest Labs Llc | LINZESS | linaclotide | CAPSULE;ORAL | 202811-002 | Aug 30, 2012 | RX | Yes | Yes | 7,304,036 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Forest Labs Llc | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | RX | Yes | No | 7,745,409 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Forest Labs Llc | LINZESS | linaclotide | CAPSULE;ORAL | 202811-002 | Aug 30, 2012 | RX | Yes | Yes | 8,933,030 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Forest Labs Llc | LINZESS | linaclotide | CAPSULE;ORAL | 202811-002 | Aug 30, 2012 | RX | Yes | Yes | 8,110,553 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Forest Labs Llc | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | RX | Yes | No | 7,304,036 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,772,188 | Methods and compositions for the treatment of gastrointestinal disorders | ► Subscribe | |||||||||||||||||||||||||||
| 7,910,546 | Methods and compositions for the treatment of gastrointestinal disorders | ► Subscribe | |||||||||||||||||||||||||||
| 2,014,073,571 | ► Subscribe | ||||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2558050 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 2246360 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 201101523 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2353383 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2015098476 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013000045 | Germany | ► Subscribe | PRODUCT NAME: LINACLOTID UND JEDE THERAPEUTISCH AEQUIVALENTE FORM DAVON, WELCHE DURCH DAS GRUNDPATENT GESCHUETZT IST, EINSCHLIESSLICH DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126 | ||||||||||||||||||||||||||
| 00594 | Netherlands | ► Subscribe | PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126 | ||||||||||||||||||||||||||
| 200 | Luxembourg | ► Subscribe | PRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUICI,PROTEGE PAR LE BREVET DE BASE,Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES | ||||||||||||||||||||||||||
| 2013013 | Lithuania | ► Subscribe | PRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126 | ||||||||||||||||||||||||||
| 00593 | Netherlands | ► Subscribe | PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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