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Isotretinoin - Generic Drug Details
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What are the generic sources for isotretinoin and what is the scope of freedom to operate?
Isotretinoin
is the generic ingredient in nine branded drugs marketed by Sun Pharm Inds Inc, Sun Pharm, Hoffmann La Roche, Mylan Pharms Inc, Teva Pharms Usa, Amneal Pharms Ny, Douglas Pharms, Sun Pharm Inds Ltd, and Dr Reddys Labs Ltd, and is included in eleven NDAs. There are seven patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Isotretinoin has twenty-nine patent family members in thirteen countries.
There are thirteen drug master file entries for isotretinoin. Six suppliers are listed for this compound.
Summary for isotretinoin
International Patents: | 29 |
US Patents: | 7 |
Tradenames: | 9 |
Applicants: | 9 |
NDAs: | 11 |
Drug Master File Entries: | 13 |
Suppliers / Packagers: | 6 |
Bulk Api Vendors: | 64 |
Clinical Trials: | 128 |
Patent Applications: | 7,272 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for isotretinoin |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for isotretinoin |
DailyMed Link: | isotretinoin at DailyMed |
Recent Clinical Trials for isotretinoin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Pennsylvania | Phase 4 |
Medical University of South Carolina | Phase 1/Phase 2 |
Beth Israel Deaconess Medical Center | Phase 4 |
Pharmacology for isotretinoin
Drug Class | Retinoid |
Medical Subject Heading (MeSH) Categories for isotretinoin
Paragraph IV (Patent) Challenges for ISOTRETINOIN
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
ABSORICA | CAPSULE;ORAL | isotretinoin | 021951 | 2016-05-16 |
ABSORICA | CAPSULE;ORAL | isotretinoin | 021951 | 2015-11-25 |
ABSORICA | CAPSULE;ORAL | isotretinoin | 021951 | 2013-06-20 |
ABSORICA | CAPSULE;ORAL | isotretinoin | 021951 | 2013-06-19 |
ABSORICA | CAPSULE;ORAL | isotretinoin | 021951 | 2013-01-07 |
ABSORICA | CAPSULE;ORAL | isotretinoin | 021951 | 2012-12-31 |
US Patents and Regulatory Information for isotretinoin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm | ABSORICA LD | isotretinoin | CAPSULE;ORAL | 211913-006 | Nov 5, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Teva Pharms Usa | CLARAVIS | isotretinoin | CAPSULE;ORAL | 076356-001 | Apr 11, 2003 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Sun Pharm Inds Ltd | SOTRET | isotretinoin | CAPSULE;ORAL | 076503-001 | Jun 20, 2003 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for isotretinoin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-002 | May 7, 1982 | Start Trial | Start Trial |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | Start Trial | Start Trial |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-003 | May 7, 1982 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for isotretinoin
Country | Patent Number | Estimated Expiration |
---|---|---|
Canada | 2963206 | Start Trial |
Portugal | 1318791 | Start Trial |
Brazil | 112017006779 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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