LINACLOTIDE Drug Patent Profile
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Which patents cover Linaclotide, and when can generic versions of Linaclotide launch?
Linaclotide is a drug marketed by Aurobindo Pharma and Mylan and is included in two NDAs.
The generic ingredient in LINACLOTIDE is linaclotide. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linaclotide profile page.
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Summary for LINACLOTIDE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 43 |
| Clinical Trials: | 44 |
| Patent Applications: | 298 |
| 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 |
|---|---|
| Jinling Hospital, China | N/A |
| AbbVie | Phase 2 |
| AbbVie | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for LINACLOTIDE
Paragraph IV (Patent) Challenges for LINACLOTIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LINZESS | Capsules | linaclotide | 72 mcg | 202811 | 1 | 2017-11-07 |
| LINZESS | Capsules | linaclotide | 145 mcg and 290 mcg | 202811 | 4 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | LINACLOTIDE | linaclotide | CAPSULE;ORAL | 209611-001 | Feb 7, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | LINACLOTIDE | linaclotide | CAPSULE;ORAL | 209564-002 | Feb 9, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma | LINACLOTIDE | linaclotide | CAPSULE;ORAL | 209611-002 | Feb 7, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | LINACLOTIDE | linaclotide | CAPSULE;ORAL | 209564-001 | Feb 9, 2021 | DISCN | No | No | ⤷ 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 |
EU/EMA Drug Approvals for LINACLOTIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| AbbVie Deutschland GmbH & Co. KG | Constella | linaclotide | EMEA/H/C/002490 Constella is indicated for the symptomatic treatment of moderate to severe irritable-bowel syndrome with constipation (IBS-C) in adults. |
Authorised | no | no | no | 2012-11-26 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
