.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

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

DrugPatentWatch Database Preview

Sirolimus - Generic Drug Details

« Back to Dashboard
Sirolimus is the generic ingredient in two branded drugs marketed by Pf Prism Cv, Zydus Pharms Usa Inc, and Dr Reddys Labs Ltd, and is included in four NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for sirolimus. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: sirolimus

Tradenames:2
Patents:1
Applicants:3
NDAs:4
Drug Master File Entries: see list16
Suppliers / Packaging: see list6
Formulation / Manufacturing:see details

Pharmacology for Ingredient: sirolimus

Tentative approvals for SIROLIMUS

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL1MG

Clinical Trials for: sirolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-002Aug 22, 2002RXYes<disabled><disabled>
Dr Reddys Labs Ltd
SIROLIMUS
sirolimus
TABLET;ORAL201578-002Oct 27, 2014RXNo<disabled><disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-004Jan 25, 2010RXNo5,989,591*PED<disabled>Y<disabled>
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: sirolimus

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-003Feb 23, 20045,100,899*PED<disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-001Aug 25, 20005,145,684*PED<disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
SOLUTION;ORAL021083-001Sep 15, 19995,100,899*PED<disabled>
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

How are People Using DrugPatentWatch?

`abc