FACTREL Drug Patent Profile
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Which patents cover Factrel, and when can generic versions of Factrel launch?
Factrel is a drug marketed by Hikma and is included in one NDA.
The generic ingredient in FACTREL is gonadorelin hydrochloride. There are seven drug master file entries for this compound. Additional details are available on the gonadorelin hydrochloride profile page.
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Summary for FACTREL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 21 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | FACTREL at DailyMed |
US Patents and Regulatory Information for FACTREL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-001 | Sep 30, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-002 | Sep 30, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-003 | Sep 30, 1982 | DISCN | 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 |
Expired US Patents for FACTREL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-003 | Sep 30, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-003 | Sep 30, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-001 | Sep 30, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-002 | Sep 30, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-002 | Sep 30, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-001 | Sep 30, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FACTREL
See the table below for patents covering FACTREL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 5150573 | ⤷ Sign Up | |
| United Kingdom | 1425512 | ⤷ Sign Up | |
| Japan | S5729462 | ⤷ Sign Up | |
| Switzerland | 589608 | ⤷ Sign Up | |
| New Zealand | 169577 | PREPARATION OF LH-AND FSH-RELEASING HORMONE,INTERMEDIATES,AND PHARMACEUTICAL COMPOSITIONS | ⤷ Sign Up |
| Germany | 2307010 | ⤷ Sign Up | |
| >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.
ISSN: 2162-2639
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