Capsaicin - Generic Drug Details
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What are the generic drug sources for capsaicin and what is the scope of freedom to operate?
Capsaicin
is the generic ingredient in one branded drug marketed by Averitas and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Capsaicin has eighty-five patent family members in twenty-nine countries.
There are six drug master file entries for capsaicin.
Summary for capsaicin
| International Patents: | 85 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 137 |
| Clinical Trials: | 187 |
| Patent Applications: | 7,425 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for capsaicin |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for capsaicin |
| What excipients (inactive ingredients) are in capsaicin? | capsaicin excipients list |
| DailyMed Link: | capsaicin at DailyMed |
Recent Clinical Trials for capsaicin
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Centenario Hospital Miguel Hidalgo | Phase 2 |
| Instituto Mexicano del Seguro Social | Phase 2 |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | N/A |
Medical Subject Heading (MeSH) Categories for capsaicin
US Patents and Regulatory Information for capsaicin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Averitas | QUTENZA | capsaicin | PATCH;TOPICAL | 022395-001 | Nov 16, 2009 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Averitas | QUTENZA | capsaicin | PATCH;TOPICAL | 022395-001 | Nov 16, 2009 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Averitas | QUTENZA | capsaicin | PATCH;TOPICAL | 022395-001 | Nov 16, 2009 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for capsaicin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Averitas | QUTENZA | capsaicin | PATCH;TOPICAL | 022395-001 | Nov 16, 2009 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for capsaicin
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Grunenthal GmbH | Qutenza | capsaicin | EMEA/H/C/000909 Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain. |
Authorised | no | no | no | 2009-05-15 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for capsaicin
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Eurasian Patent Organization | 200500442 | КОМПОЗИЦИИ И НАБОРЫ ДЛЯ УДАЛЕНИЯ РАЗДРАЖАЮЩИХ СОЕДИНЕНИЙ С ПОВЕРХНОСТЕЙ ТЕЛА | See Plans and Pricing |
| Japan | 4921371 | See Plans and Pricing | |
| Norway | 337896 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
