COLCRYS Drug Patent Profile
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Which patents cover Colcrys, and what generic alternatives are available?
Colcrys is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are seventeen patents protecting this drug and two Paragraph IV challenges.
The generic ingredient in COLCRYS is colchicine. There are sixteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the colchicine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Colcrys
A generic version of COLCRYS was approved as colchicine by AMNEAL PHARMS on September 28th, 2016.
Summary for COLCRYS
| US Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 111 |
| Clinical Trials: | 24 |
| Patent Applications: | 4,313 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for COLCRYS |
| Drug Sales Revenues: | Drug sales revenues for COLCRYS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for COLCRYS |
| What excipients (inactive ingredients) are in COLCRYS? | COLCRYS excipients list |
| DailyMed Link: | COLCRYS at DailyMed |
Recent Clinical Trials for COLCRYS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| VA Office of Research and Development | Phase 4 |
| NYU School of Medicine | Phase 4 |
| Helwan University | Phase 3 |
Pharmacology for COLCRYS
| Drug Class | Alkaloid |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Anatomical Therapeutic Chemical (ATC) Classes for COLCRYS
Paragraph IV (Patent) Challenges for COLCRYS
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| COLCRYS | Tablets | colchicine | 0.3 mg | 022352 | 1 | 2019-07-19 |
| COLCRYS | Tablets | colchicine | 0.6 mg | 022352 | 1 | 2011-12-23 |
US Patents and Regulatory Information for COLCRYS
COLCRYS is protected by seventeen US patents.
Patents protecting COLCRYS
Methods for concomitant administration of colchicine and macrolide antibiotics in the treatment of gout flares
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING GOUT FLARES
Methods for concomitant administration of colchicine and macrolide antibiotics
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Methods for concomitant administration of colchicine and a second active agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Methods for concomitant administration of colchicine and a second active agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF ADMINISTERING COLCHICINE TO FAMILIAL MEDITERRANEAN FEVER PATIENTS
Methods for concomitant administration of colchicine and a second active agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING GOUT FLARES
Methods for concomitant administration of colchicine and macrolide antibiotics
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF ADMINISTERING COLCHICINE TO FAMILIAL MEDITERRANEAN FEVER PATIENTS
Colchicine compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING GOUT FLARES
Methods for concomitant administration of colchicine and a second active agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT AND PROPHYLAXIS OF GOUT FLARES & THE TREATMENT OF FAMILIAL MEDITERRANEAN FEVER
Colchicine compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR TREATMENT OF GOUT FLARES DURING PROPHYLAXIS
Methods for concomitant administration of colchicine and macrolide antibiotics
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING GOUT FLARES
Methods for concomitant administration of colchicine and a second active agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT AND PROPHYLAXIS OF GOUT FLARES & THE TREATMENT OF FAMILIAL MEDITERRANEAN FEVER
Methods for concomitant administration of colchicine and macrolide antibiotics
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF ADMINISTERING COLCHICINE TO FAMILIAL MEDITERRANEAN FEVER PATIENTS
Methods for concomitant administration of colchicine and macrolide antibiotics
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Colchicine compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING GOUT FLARES
Colchine compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING GOUT FLARES
Methods for concomitant administration of colchicine and a second active agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING GOUT FLARES
Methods for concomitant administration of colchicine and a second active agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | AB | RX | Yes | Yes | ⤷ 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 |
