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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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