Benzoyl peroxide; tretinoin - Generic Drug Details
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What are the generic drug sources for benzoyl peroxide; tretinoin and what is the scope of freedom to operate?
Benzoyl peroxide; tretinoin
is the generic ingredient in one branded drug marketed by Galderma Labs Lp and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Benzoyl peroxide; tretinoin has sixty-three patent family members in thirteen countries.
One supplier is listed for this compound.
Summary for benzoyl peroxide; tretinoin
International Patents: | 63 |
US Patents: | 7 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 9 |
DailyMed Link: | benzoyl peroxide; tretinoin at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for benzoyl peroxide; tretinoin
Generic Entry Date for benzoyl peroxide; tretinoin*:
Constraining patent/regulatory exclusivity:
Dosage:
CREAM;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for benzoyl peroxide; tretinoin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
GWT-TUD GmbH | Phase 4 |
Galderma Laboratories, L.P. | Phase 4 |
Zeichner, Joshua, M.D. | Phase 4 |
Pharmacology for benzoyl peroxide; tretinoin
Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for benzoyl peroxide; tretinoin
US Patents and Regulatory Information for benzoyl peroxide; tretinoin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Galderma Labs Lp | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Galderma Labs Lp | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Galderma Labs Lp | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for benzoyl peroxide; tretinoin
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 200801146 | Metal oxide coating of water insoluble ingredients | ⤷ Sign Up |
South Korea | 101158162 | ⤷ Sign Up | |
European Patent Office | 1919606 | REVETEMENT PAR UN OXYDE METALLIQUE D'INGREDIENTS HYDROINSOLUBLES (METAL OXIDE COATING OF WATER INSOLUBLE INGREDIENTS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for benzoyl peroxide; tretinoin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1458369 | CA 2008 00029 | Denmark | ⤷ Sign Up | PRODUCT NAME: ADAPALEN, BENZOYLPEROXID |
1586316 | 122011100019 | Germany | ⤷ Sign Up | PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518 |
0137963 | 97C0042 | Belgium | ⤷ Sign Up | PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.