isotretinoin - Profile
What are the generic sources for isotretinoin and what is the scope of patent protection?
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, Actavis Labs Fl, Amneal Pharms Ny, Aurobindo Pharma, Aurobindo Pharma Ltd, Upsher Smith Labs, Zydus Pharms, Sun Pharm Inds Ltd, and Dr Reddys Labs Ltd, and is included in nineteen NDAs. There are two patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Summary for isotretinoin
| International Patents: | 17 |
| US Patents: | 2 |
| Tradenames: | 9 |
| Applicants: | 12 |
| NDAs: | 18 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for isotretinoin |
Paragraph IV (Patent) Challenges for ISOTRETINOIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ABSORICA | Capsules | isotretinoin | 25 mg | 021951 | 1 | 2016-05-16 |
| ABSORICA | Capsules | isotretinoin | 35 mg | 021951 | 1 | 2015-11-25 |
| ABSORICA | Capsules | isotretinoin | 10 mg | 021951 | 1 | 2013-06-20 |
| ABSORICA | Capsules | isotretinoin | 20 mg | 021951 | 1 | 2013-01-07 |
| ABSORICA | Capsules | isotretinoin | 40 mg | 021951 | 1 | 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 Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-001 | May 25, 2012 | AB2 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-002 | May 25, 2012 | AB2 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-005 | Aug 15, 2014 | AB2 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-003 | May 25, 2012 | AB2 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-006 | Aug 15, 2014 | AB2 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-004 | May 25, 2012 | AB2 | RX | Yes | Yes | ⤷ 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 |
|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-002 | May 25, 2012 | 8,367,102 | ⤷ Start Trial |
| Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-002 | May 7, 1982 | 4,200,647 | ⤷ Start Trial |
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-006 | Aug 15, 2014 | 9,078,925 | ⤷ Start Trial |
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-004 | May 25, 2012 | 7,435,427 | ⤷ Start Trial |
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-003 | May 25, 2012 | 9,078,925 | ⤷ Start Trial |
| Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-002 | May 7, 1982 | 4,322,438 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for isotretinoin
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2015294993 | ⤷ Start Trial | |
| Brazil | 112017001963 | ⤷ Start Trial | |
| Canada | 2956831 | ⤷ Start Trial | |
| European Patent Office | 3174601 | ⤷ Start Trial | |
| Japan | 2017521470 | イソトレチノインの経口医薬組成物 | ⤷ Start Trial |
| Mexico | 2017001331 | COMPOSICION FARMACEUTICA ORAL DE ISOTRETINOINA. (ORAL PHARMACEUTICAL COMPOSITION OF ISOTRETINOIN.) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
