Colchicine - Generic Drug Details
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What are the generic drug sources for colchicine and what is the scope of freedom to operate?
Colchicine
is the generic ingredient in nine branded drugs marketed by Par Pharm Inc, Hikma Intl Pharms, Scilex Pharms, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Granules, Hetero Labs Ltd V, Mylan, Strides Pharma, Watson Labs Inc, Zydus Pharms, Takeda Pharms Usa, Watson Labs, Merck, Ani Pharms, Beecham, Impax Labs, Novast Labs, Sandoz, and Lederle, and is included in twenty-five NDAs. There are twenty-six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Colchicine has three patent family members in two countries.
There are sixteen drug master file entries for colchicine. Twenty-seven suppliers are listed for this compound.
Summary for colchicine
International Patents: | 3 |
US Patents: | 26 |
Tradenames: | 9 |
Applicants: | 22 |
NDAs: | 25 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 27 |
Raw Ingredient (Bulk) Api Vendors: | 108 |
Clinical Trials: | 231 |
Patent Applications: | 6,528 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
Recent Clinical Trials for colchicine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
NYU School of Medicine | Phase 4 |
I.M. Sechenov First Moscow State Medical University | Phase 1/Phase 2 |
Chinese University of Hong Kong | Phase 2 |
Pharmacology for colchicine
Drug Class | Alkaloid |
Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions Cytochrome P450 3A4 Inhibitors |
Medical Subject Heading (MeSH) Categories 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
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Watson Labs | PROBENECID W/ COLCHICINE | colchicine; probenecid | TABLET;ORAL | 083221-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Amneal Pharms | COLCHICINE | colchicine | TABLET;ORAL | 204711-001 | Sep 28, 2016 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 colchicine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2017156392 | See Plans and Pricing | |
European Patent Office | 3426227 | COMPOSITION ET MÉTHODE D'UTILISATION DE LIQUIDE ORAL DE COLCHICINE (COMPOSITION AND METHOD OF USE OF COLCHICINE ORAL LIQUID) | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2019126579 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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