HYFTOR Drug Patent Profile
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Which patents cover Hyftor, and what generic alternatives are available?
Hyftor is a drug marketed by Nobelpharma and is included in one NDA.
The generic ingredient in HYFTOR is sirolimus. There are twenty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Hyftor
A generic version of HYFTOR was approved as sirolimus by ZYDUS PHARMS on January 8th, 2014.
Summary for HYFTOR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Patent Applications: | 3,445 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for HYFTOR |
| What excipients (inactive ingredients) are in HYFTOR? | HYFTOR excipients list |
| DailyMed Link: | HYFTOR at DailyMed |
Pharmacology for HYFTOR
| Drug Class | Kinase Inhibitor mTOR Inhibitor Immunosuppressant |
| Mechanism of Action | Protein Kinase Inhibitors mTOR Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
Anatomical Therapeutic Chemical (ATC) Classes for HYFTOR
US Patents and Regulatory Information for HYFTOR
HYFTOR is protected by zero US patents and two FDA Regulatory Exclusivities.
FDA Regulatory Exclusivity protecting HYFTOR
TREATMENT OF FACIAL ANGIOFIBROMA ASSOCIATED WITH TUBEROUS SCLEROSIS IN ADULTS AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Try a Trial
NEW PRODUCT
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nobelpharma | HYFTOR | sirolimus | GEL;TOPICAL | 213478-001 | Mar 22, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Nobelpharma | HYFTOR | sirolimus | GEL;TOPICAL | 213478-001 | Mar 22, 2022 | 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 |
EU/EMA Drug Approvals for HYFTOR
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer Europe MA EEIG | Rapamune | sirolimus | EMEA/H/C/000273 Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued., , Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function., |
Authorised | no | no | no | 2001-03-13 | |
| Plusultra pharma GmbH | Hyftor | sirolimus | EMEA/H/C/005896 Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older. |
Authorised | no | no | yes | 2023-05-15 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
