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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Benzoyl peroxide; tretinoin has forty-seven patent family members in thirteen countries.
One supplier is listed for this compound.
Summary for BENZOYL PEROXIDE; TRETINOIN
| International Patents: | 47 |
| US Patents: | 5 |
| 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Galderma Labs Lp | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Galderma Labs Lp | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Galderma Labs Lp | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Galderma Labs Lp | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Galderma Labs Lp | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 Korea | 101158162 | ⤷ Try a Trial | |
| Brazil | PI0808163 | COMPOSIÇÃO PARA APLICAÇÃO TÓPICA, MÉTODOS PARA TRATAR UMA CONDIÇÃO DE SUPERFÍCIE EM UM INDIVÍDUO, PARA PREPARAR UMA COMPOSIÇÃO, E PARA USAR O KIT, E, KIT | ⤷ Try a Trial |
| China | 102596186 | Core stabilized microcapsules, method of their preparation and uses thereof | ⤷ Try a Trial |
| China | 110891561 | 治疗痤疮的方法和组合物 (METHODS AND COMPOSITIONS FOR THE TREATMENT OF ACNE) | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2011080741 | ⤷ Try a Trial | |
| Mexico | 344128 | MICROCAPSULAS ESTABILIZADAS CON NUCLEO, METODO PARA SU PREPARACION Y USOS DE LAS MISMAS. (CORE STABILIZED MICROCAPSULES, METHOD OF THEIR PREPARATION AND USES THEREOF.) | ⤷ Try a Trial |
| Brazil | 112012012023 | processo para preparar microcápsulas, microcápsulas, composição, método para tratar uma condição superficial em um indivíduo, e, uso das microcápsulas | ⤷ Try a Trial |
| >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 | C01458369/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009 |
| 1458369 | 122008000041 | Germany | ⤷ Try a Trial | PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218 |
| 1458369 | SPC/GB10/005 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111 |
| 0591275 | SPC/GB05/030 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221 |
| 1586316 | SPC/GB11/054 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523 |
| 1586316 | 122011100019 | Germany | ⤷ Try a Trial | PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518 |
| 1458369 | CA 2008 00029 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ADAPALEN, BENZOYLPEROXID |
| >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.
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