MAKENA PRESERVATIVE FREE Drug Patent Profile
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When do Makena Preservative Free patents expire, and what generic alternatives are available?
Makena Preservative Free is a drug marketed by Covis and is included in one NDA.
The generic ingredient in MAKENA PRESERVATIVE FREE is hydroxyprogesterone caproate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Makena Preservative Free
A generic version of MAKENA PRESERVATIVE FREE was approved as hydroxyprogesterone caproate by ASPEN GLOBAL INC on August 24th, 2015.
Summary for MAKENA PRESERVATIVE FREE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 2 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | MAKENA PRESERVATIVE FREE at DailyMed |
Recent Clinical Trials for MAKENA PRESERVATIVE FREE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AMAG Pharmaceuticals, Inc. | Phase 3 |
| AMAG Pharmaceuticals, Inc. | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for MAKENA PRESERVATIVE FREE
US Patents and Regulatory Information for MAKENA PRESERVATIVE FREE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Covis | MAKENA PRESERVATIVE FREE | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 021945-002 | Feb 19, 2016 | AP | 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 |
International Patents for MAKENA PRESERVATIVE FREE
See the table below for patents covering MAKENA PRESERVATIVE FREE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20070117543 | PREFILLED NEEDLE ASSISTED JET INJECTOR | See Plans and Pricing |
| China | 101132820 | Prefilled needle assisted jet injector | See Plans and Pricing |
| Germany | 69921704 | See Plans and Pricing | |
| Denmark | 2953667 | See Plans and Pricing | |
| Austria | 240756 | See Plans and Pricing | |
| Japan | 5216328 | See Plans and Pricing | |
| >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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2022, www.DrugPatentWatch.com.
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