TACROLIMUS Drug Patent Profile
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Which patents cover Tacrolimus, and what generic alternatives are available?
Tacrolimus is a drug marketed by Chengdu, Accord Hlthcare, Alkem Labs Ltd, Belcher, Biocon Pharma, Concord Biotech Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hangzhou Zhongmei, Heritage Pharma Avet, Mylan, Panacea, Sandoz, Strides Pharma, Hospira, Encube, and Fougera Pharms Inc. and is included in nineteen NDAs.
The generic ingredient in TACROLIMUS is tacrolimus. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tacrolimus
A generic version of TACROLIMUS was approved as tacrolimus by SANDOZ on August 10th, 2009.
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Summary for TACROLIMUS
| US Patents: | 0 |
| Applicants: | 17 |
| NDAs: | 19 |
| Finished Product Suppliers / Packagers: | 30 |
| Raw Ingredient (Bulk) Api Vendors: | 80 |
| Clinical Trials: | 1,319 |
| Drug Prices: | Drug price information for TACROLIMUS |
| Drug Sales Revenues: | Drug sales revenues for TACROLIMUS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TACROLIMUS |
| What excipients (inactive ingredients) are in TACROLIMUS? | TACROLIMUS excipients list |
| DailyMed Link: | TACROLIMUS at DailyMed |
See drug prices for TACROLIMUS
Recent Clinical Trials for TACROLIMUS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Beijing Tsinghua Chang Gung Hospital | Phase 4 |
| The Children's Hospital of Zhejiang University School of Medicine | Phase 3 |
| AstraZeneca | Phase 3 |
Pharmacology for TACROLIMUS
| Drug Class | Calcineurin Inhibitor Immunosuppressant |
| Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for TACROLIMUS
Anatomical Therapeutic Chemical (ATC) Classes for TACROLIMUS
Paragraph IV (Patent) Challenges for TACROLIMUS
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ENVARSUS XR | Extended-release Tablets | tacrolimus | 0.75 mg, 1 mg and 4 mg | 206406 | 1 | 2022-03-31 |
| ASTAGRAF XL | Extended-release Capsules | tacrolimus | 0.5 mg, 1 mg, and 5 mg | 204096 | 1 | 2013-09-24 |
| PROTOPIC | Ointment | tacrolimus | 0.03% | 050777 | 1 | 2010-11-22 |
| PROTOPIC | Ointment | tacrolimus | 0.10% | 050777 | 1 | 2010-09-09 |
US Patents and Regulatory Information for TACROLIMUS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospira | TACROLIMUS | tacrolimus | INJECTABLE;INJECTION | 203900-001 | Aug 25, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Panacea | TACROLIMUS | tacrolimus | CAPSULE;ORAL | 090802-001 | Sep 28, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fougera Pharms Inc | TACROLIMUS | tacrolimus | OINTMENT;TOPICAL | 200744-001 | Sep 9, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Heritage Pharma Avet | TACROLIMUS | tacrolimus | CAPSULE;ORAL | 090402-001 | Jul 1, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Panacea | TACROLIMUS | tacrolimus | CAPSULE;ORAL | 090802-002 | Sep 28, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 TACROLIMUS
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Astellas Pharma Europe B.V. | Modigraf | tacrolimus | EMEA/H/C/000954 Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients. |
Authorised | no | no | no | 2009-05-15 | |
| Astellas Pharma Europe BV | Advagraf | tacrolimus | EMEA/H/C/000712 Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients. |
Authorised | no | no | no | 2007-04-23 | |
| Chiesi Farmaceutici S.p.A. | Envarsus | tacrolimus | EMEA/H/C/002655 Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients. |
Authorised | no | no | no | 2014-07-18 | |
| LEO Pharma A/S | Protopic | tacrolimus | EMEA/H/C/000374 Flare treatmentAdults and adolescents (16 years of age and above)Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.Children (two years of age and above)Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatmentMaintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected). |
Authorised | no | no | no | 2002-02-27 | |
| Teva B.V. | Tacforius | tacrolimus | EMEA/H/C/004435 Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients. |
Authorised | yes | no | no | 2017-12-08 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
