ABSORICA Drug Patent Profile
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Which patents cover Absorica, 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.
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Summary for ABSORICA
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 10 |
| Patent Applications: | 7,499 |
| 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 |
| Sun Pharmaceutical Industries Limited | Phase 4 |
Pharmacology for ABSORICA
| Drug Class | Retinoid |
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
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm | ABSORICA LD | isotretinoin | CAPSULE;ORAL | 211913-006 | Nov 5, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sun Pharm | ABSORICA LD | isotretinoin | CAPSULE;ORAL | 211913-001 | Nov 5, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 ABSORICA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-003 | May 25, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-005 | Aug 15, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-005 | Aug 15, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| European Patent Office | 2964195 | COMPOSITION SEMI-SOLIDE PHARMACEUTIQUE D'ISOTRÉTINOÏNE (PHARMACEUTICAL SEMI-SOLID COMPOSITION OF ISOTRETINOIN) | ⤷ Sign Up |
| Germany | 60104206 | ⤷ Sign Up | |
| European Patent Office | 1318791 | COMPOSITION PHARMACEUTIQUE SEMI-SOLIDE D'ISOTRETINOINE (PHARMACEUTICAL SEMI-SOLID COMPOSITION OF ISOTRETINOIN) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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