ABSORICA Drug Patent Profile
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When do Absorica patents expire, and what generic alternatives are available?
Absorica is a drug marketed by Sun Pharm Inds Inc and Sun Pharm and is included in two NDAs. There are two patents protecting this drug and five Paragraph IV challenges.
The generic ingredient in ABSORICA is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Absorica
A generic version of ABSORICA was approved as isotretinoin by AMNEAL PHARMS NY on September 29th, 2017.
Summary for ABSORICA
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 9 |
Patent Applications: | 7,681 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ABSORICA |
Drug Sales Revenues: | Drug sales revenues for ABSORICA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ABSORICA |
What excipients (inactive ingredients) are in ABSORICA? | ABSORICA excipients list |
DailyMed Link: | ABSORICA at DailyMed |
Recent Clinical Trials for ABSORICA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Children's Oncology Group | Phase 2 |
National Cancer Institute (NCI) | Phase 2 |
Ranbaxy Inc. | Phase 4 |
Pharmacology for ABSORICA
Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for ABSORICA
Paragraph IV (Patent) Challenges for ABSORICA
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 ABSORICA
Expired US Patents for ABSORICA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-006 | Aug 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-006 | Aug 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-002 | May 25, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-002 | May 25, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-001 | May 25, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-006 | Aug 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-005 | Aug 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ABSORICA
See the table below for patents covering ABSORICA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 1318791 | ⤷ Try a Trial | |
Canada | 2836228 | COMPOSITION PHARMACEUTIQUE SEMI-SOLIDE D'ISOTRETINOINE (PHARMACEUTICAL SEMI-SOLID COMPOSITION OF ISOTRETINOIN) | ⤷ Try a Trial |
Canada | 2423170 | COMPOSITION PHARMACEUTIQUE SEMI-SOLIDE D'ISOTRETINOINE (PHARMACEUTICAL SEMI-SOLID COMPOSITION OF ISOTRETINOIN) | ⤷ Try a Trial |
European Patent Office | 2964195 | COMPOSITION SEMI-SOLIDE PHARMACEUTIQUE D'ISOTRÉTINOÏNE (PHARMACEUTICAL SEMI-SOLID COMPOSITION OF ISOTRETINOIN) | ⤷ Try a Trial |
Germany | 60104206 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 0224172 | ⤷ Try a Trial | |
Spain | 2225600 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |