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 ten 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, Agepha Pharma Fz, Watson Labs, Merck, Ani Pharms, Beecham, Impax Labs, Novast Labs, Rising, Sandoz, and Lederle, and is included in twenty-seven NDAs. There are thirty-six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Colchicine has seventy-nine patent family members in twenty-five countries.
There are sixteen drug master file entries for colchicine. Twenty-nine suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for colchicine
International Patents: | 79 |
US Patents: | 36 |
Tradenames: | 10 |
Applicants: | 24 |
NDAs: | 27 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 29 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Clinical Trials: | 248 |
Patent Applications: | 6,926 |
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 |
---|---|
Foundation for Cardiovascular Research Basel | Phase 3 |
University Hospital, Basel, Switzerland | Phase 3 |
Fondation Machaon, Switzerland, Genf | Phase 3 |
Generic filers with tentative approvals for COLCHICINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 0.6MG/5ML | SOLUTION;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Watson Labs | PROBEN-C | colchicine; probenecid | TABLET;ORAL | 085552-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma Intl Pharms | MITIGARE | colchicine | CAPSULE;ORAL | 204820-001 | Sep 26, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Agepha Pharma Fz | LODOCO | colchicine | TABLET;ORAL | 215727-001 | Jun 16, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma Intl Pharms | MITIGARE | colchicine | CAPSULE;ORAL | 204820-001 | Sep 26, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Par Pharm Inc | COLCHICINE | colchicine | TABLET;ORAL | 203976-001 | Aug 12, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Lederle | PROBENECID W/ COLCHICINE | colchicine; probenecid | TABLET;ORAL | 086954-001 | Approved Prior to Jan 1, 1982 | DISCN | 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 |
International Patents for colchicine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Chile | 2015001154 | Tratamiento o prevencion de eventos cardiovasculares mediante la administracion de un derivado de colchicina. | ⤷ Try a Trial |
Australia | 2019201048 | Sustained-release formulations of colchicine and methods of using same | ⤷ Try a Trial |
Australia | 2021282491 | Treatment or prevention of cardiovascular events via the administration of a colchicine derivative | ⤷ Try a Trial |
Hungary | E054663 | ⤷ Try a Trial | |
South Korea | 20220001518 | 콜히친 유도체의 투여를 통한 심혈관성 병태의 치료 또는 예방 (TREATMENT OR PREVENTION OF CARDIOVASCULAR EVENTS VIA THE ADMINISTRATION OF A COLCHICINE DERIVATIV) | ⤷ Try a Trial |
Poland | 2914255 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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