COLCHICINE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Colchicine, and when can generic versions of Colchicine launch?
Colchicine is a drug marketed by Par Pharm Inc, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Granules, Hetero Labs Ltd V, Mylan, Strides Pharma, Watson Labs Inc, and Zydus Pharms. and is included in twelve NDAs.
The generic ingredient in COLCHICINE is colchicine. There are sixteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the colchicine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Colchicine
A generic version of COLCHICINE was approved as colchicine by AMNEAL PHARMS on September 28th, 2016.
Summary for COLCHICINE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 23 |
| Raw Ingredient (Bulk) Api Vendors: | 113 |
| Clinical Trials: | 248 |
| Patent Applications: | 4,115 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for COLCHICINE |
| Drug Sales Revenues: | Drug sales revenues for COLCHICINE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for COLCHICINE |
| What excipients (inactive ingredients) are in COLCHICINE? | COLCHICINE excipients list |
| DailyMed Link: | COLCHICINE at DailyMed |
See drug prices for COLCHICINE
Recent Clinical Trials for COLCHICINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital, Basel, Switzerland | Phase 3 |
| Fondation Machaon, Switzerland, Genf | Phase 3 |
| Swiss Heart Foundation | Phase 3 |
Pharmacology for COLCHICINE
| Drug Class | Alkaloid |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for COLCHICINE
Anatomical Therapeutic Chemical (ATC) Classes for COLCHICINE
Paragraph IV (Patent) Challenges for COLCHICINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| GLOPERBA | Oral Solution | colchicine | 0.6 mg/5 mL | 210942 | 1 | 2020-04-02 |
| COLCRYS | Tablets | colchicine | 0.3 mg | 022352 | 1 | 2019-07-19 |
| MITIGARE | Capsules | colchicine | 0.6 mg | 204820 | 1 | 2016-06-10 |
| COLCRYS | Tablets | colchicine | 0.6 mg | 022352 | 1 | 2011-12-23 |
US Patents and Regulatory Information for COLCHICINE
COLCHICINE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting COLCHICINE
PATENT CHALLENGE
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Pharm Inc | COLCHICINE | colchicine | CAPSULE;ORAL | 208678-001 | Nov 29, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hetero Labs Ltd V | COLCHICINE | colchicine | TABLET;ORAL | 208993-001 | Aug 13, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Aurobindo Pharma Ltd | COLCHICINE | colchicine | TABLET;ORAL | 215444-001 | Jan 6, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | COLCHICINE | colchicine | TABLET;ORAL | 211519-002 | Nov 14, 2019 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
