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Linaclotide - Generic Drug Details
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What are the generic drug sources for linaclotide and what is the scope of freedom to operate?
Linaclotide
is the generic ingredient in one branded drug marketed by Allergan and is included in one NDA. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Linaclotide has one hundred and ninety-one patent family members in forty-one countries.
There are ten drug master file entries for linaclotide. One supplier is listed for this compound.
Summary for linaclotide
| International Patents: | 191 |
| US Patents: | 12 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 10 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 26 |
| Clinical Trials: | 36 |
| Patent Applications: | 463 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for linaclotide |
| DailyMed Link: | linaclotide at DailyMed |
Recent Clinical Trials for linaclotide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Allergan | Phase 2 |
| Allergan | Phase 3 |
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Phase 2 |
Pharmacology for linaclotide
| Drug Class | Guanylate Cyclase-C Agonist |
| Mechanism of Action | Guanylate Cyclase Activators |
Paragraph IV (Patent) Challenges for LINACLOTIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LINZESS | CAPSULE;ORAL | linaclotide | 202811 | 2017-11-07 |
| LINZESS | CAPSULE;ORAL | linaclotide | 202811 | 2016-08-30 |
US Patents and Regulatory Information for linaclotide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Allergan | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Allergan | LINZESS | linaclotide | CAPSULE;ORAL | 202811-003 | Jan 25, 2017 | 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 |
International Patents for linaclotide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20110114682 | Start Trial |
| Mexico | PA06010205 | Start Trial |
| China | 102869677 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for linaclotide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1594517 | 5012-2013 | Slovakia | Start Trial | PRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126 |
| 1594517 | C01594517/01 | Switzerland | Start Trial | PRODUCT NAME: LINACLOTID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62684 20.06.2013 |
| 1594517 | CA 2013 00026 | Denmark | Start Trial | |
| >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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