PROGRAF Drug Patent Profile
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Which patents cover Prograf, and what generic alternatives are available?
Prograf is a drug marketed by Astellas and is included in three NDAs.
The generic ingredient in PROGRAF is tacrolimus. There are twenty drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Prograf
A generic version of PROGRAF was approved as tacrolimus by SANDOZ on August 10th, 2009.
Summary for PROGRAF
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 66 |
| Clinical Trials: | 395 |
| Patent Applications: | 7,198 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROGRAF |
| Drug Sales Revenues: | Drug sales revenues for PROGRAF |
| What excipients (inactive ingredients) are in PROGRAF? | PROGRAF excipients list |
| DailyMed Link: | PROGRAF at DailyMed |
Recent Clinical Trials for PROGRAF
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Johns Hopkins University | Phase 3 |
| HK inno.N Corporation | Phase 1 |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Phase 2 |
Pharmacology for PROGRAF
| Drug Class | Calcineurin Inhibitor Immunosuppressant |
| Mechanism of Action | Calcineurin Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for PROGRAF
US Patents and Regulatory Information for PROGRAF
PROGRAF is protected by zero US patents and three FDA Regulatory Exclusivities.
FDA Regulatory Exclusivity protecting PROGRAF
FOR PROPHYLAXIS OF ORGAN REJECTION IN ADULT AND PEDIATRIC PATIENTS RECEIVING ALLOGENEIC LUNG TRANSPLANT
Exclusivity Expiration: See Plans and Pricing
PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY OR HEART TRANSPLANTS, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS
Exclusivity Expiration: See Plans and Pricing
PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY TRANSPLANT, LIVER TRANSPLANTS, AND HEART TRANSPLANT, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS
Exclusivity Expiration: See Plans and Pricing
Expired US Patents for PROGRAF
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astellas | PROGRAF | tacrolimus | INJECTABLE;INJECTION | 050709-001 | Apr 8, 1994 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROGRAF
See the table below for patents covering PROGRAF around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hong Kong | 62797 | A pharmaceutical solution comprising derivatives of FK506 | See Plans and Pricing |
| China | 1028961 | See Plans and Pricing | |
| Ireland | 910679 | See Plans and Pricing | |
| South Africa | 9101502 | See Plans and Pricing | |
| Greece | 3021777 | See Plans and Pricing | |
| Hungary | 209436 | PROCESS FOR PRODUCING PHARMACEUTICAL SOLUTIONS CONTAINING MACROLIDES | See Plans and Pricing |
| Germany | 69122418 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2022, www.DrugPatentWatch.com.
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