PALBOCICLIB Drug Patent Profile
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When do Palbociclib patents expire, and when can generic versions of Palbociclib launch?
Palbociclib is a drug marketed by Synthon Pharms Inc and is included in one NDA.
The generic ingredient in PALBOCICLIB is palbociclib. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the palbociclib profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Palbociclib
A generic version of PALBOCICLIB was approved as palbociclib by SYNTHON PHARMS INC on June 5th, 2024.
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Questions you can ask:
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Summary for PALBOCICLIB
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 296 |
| Patent Applications: | 1,620 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PALBOCICLIB |
| DailyMed Link: | PALBOCICLIB at DailyMed |
Recent Clinical Trials for PALBOCICLIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Medical Center Groningen | Phase 4 |
| Mohammed Milhem | Phase 1 |
| AstraZeneca | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for PALBOCICLIB
Paragraph IV (Patent) Challenges for PALBOCICLIB
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| IBRANCE | Tablets | palbociclib | 75 mg, 100 mg and 125 mg | 212436 | 1 | 2020-11-24 |
| IBRANCE | Capsules | palbociclib | 75 mg, 100 mg and 125 mg | 207103 | 12 | 2019-02-04 |
US Patents and Regulatory Information for PALBOCICLIB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Synthon Pharms Inc | PALBOCICLIB | palbociclib | TABLET;ORAL | 215570-001 | Jun 5, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Synthon Pharms Inc | PALBOCICLIB | palbociclib | TABLET;ORAL | 215570-002 | Jun 5, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Synthon Pharms Inc | PALBOCICLIB | palbociclib | TABLET;ORAL | 215570-003 | Jun 5, 2024 | 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 PALBOCICLIB
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer Europe MA EEIG | Ibrance | palbociclib | EMEA/H/C/003853 Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer:in combination with an aromatase inhibitor;in combination with fulvestrant in women who have received prior endocrine therapy.In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist. |
Authorised | no | no | no | 2016-11-09 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
