.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Tretinoin - Generic Drug Details

« Back to Dashboard
Tretinoin is the generic ingredient in eight branded drugs marketed by Mylan, Mylan Pharms Inc, Valeant Pharms North, Allergan Sales Llc, Perrigo Pharma Intl, Valeant Intl, Valeant Bermuda, Spear Pharms Inc, Roche, Wockhardt, Dow Pharm, Teva Pharms, Barr Labs Inc, Anchen Pharms, and Suneva Medcl, and is included in twenty-eight NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has nineteen patent family members in nine countries.

There are twenty-four drug master file entries for tretinoin. Twenty-four suppliers are listed for this compound.

Summary for Generic Name: tretinoin

Tradenames:8
Patents:2
Applicants:15
NDAs:28
Drug Master File Entries: see list24
Suppliers / Packaging: see list24
Therapeutic Class:Antineoplastics
Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: tretinoin

Ingredient-typeRetinoids
Drug ClassRetinoid
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo Pharma Intl
TRETINOIN
tretinoin
GEL;TOPICAL075529-001Feb 22, 2000RXNo► subscribe► subscribe
Valeant Intl
RETIN-A MICRO
tretinoin
GEL;TOPICAL020475-002May 10, 2002RXYes5,955,109► subscribe ► subscribe
Roche
VESANOID
tretinoin
CAPSULE;ORAL020438-001Nov 22, 1995DISCNNo► subscribe► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: tretinoin

These historical archives are available as an add-on to one-year subscriptions.
See the Subscription Options for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl
RETIN-A MICRO
tretinoin
GEL;TOPICAL020475-001Feb 7, 19975,955,109► subscribe
Valeant Pharms North
RENOVA
tretinoin
CREAM;TOPICAL021108-001Aug 31, 20004,603,146► subscribe
Valeant Pharms North
RENOVA
tretinoin
CREAM;TOPICAL021108-001Aug 31, 2000RE36068► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: tretinoin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,879,716 Methods and compositions for topical delivery of benzoyl peroxide► subscribe
5,145,675 Two step method for preparation of controlled release formulations► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: tretinoin

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)8801164► subscribe
Australia613398► subscribe
Germany3789956► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: TRETINOIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
01/009Ireland► subscribePRODUCT NAME: PANRETIN-ALITRETINOIN
/2001Austria► subscribePRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
401Luxembourg► subscribePRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and 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 verifification 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.

`abc