Makena (autoinjector) is a drug owned by Covis Pharma Gmbh. It is protected by 13 US drug patents filed from 2018 to 2022. Out of these, 12 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 02, 2036. Details of Makena (autoinjector)'s patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| USRE44846 | Needle assisted jet injector |
Aug, 2019
(5 years ago) |
Expired
|
| US9180259 | Prefilled syringe jet injector |
Jan, 2026
(1 year, 4 months from now) | Active |
| US9629959 | Prefilled syringe jet injector |
Jan, 2026
(1 year, 4 months from now) | Active |
| US11446441 | Prefilled syringe injector |
Jan, 2026
(1 year, 4 months from now) | Active |
| US8562564 | Prefilled syringe jet injector |
Jan, 2026
(1 year, 4 months from now) | Active |
| US9533102 | Prefilled syringe jet injector |
Jan, 2026
(1 year, 4 months from now) | Active |
| US8021335 | Prefilled syringe jet injector |
Oct, 2026
(2 years from now) | Active |
| US11446440 | Needle assisted injection device having reduced trigger force |
Aug, 2031
(6 years from now) | Active |
| US9789257 | Needle assisted injection device having reduced trigger force |
Feb, 2034
(9 years from now) | Active |
| US11304962 | Methods of reducing risk of preterm birth |
May, 2036
(11 years from now) | Active |
| US9844558 | Methods of reducing risk of preterm birth |
May, 2036
(11 years from now) | Active |
| US10471075 | Methods of reducing risk of preterm birth |
May, 2036
(11 years from now) | Active |
| US11154562 | Methods of reducing risk of preterm birth |
May, 2036
(11 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Makena (autoinjector)'s patents.
Latest Legal Activities on Makena (autoinjector)'s Patents
Given below is the list of recent legal activities going on the following patents of Makena (autoinjector).
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Jul, 2024 | US9533102 |
| Expire Patent Critical | 18 Dec, 2023 | US10471075 |
| Maintenance Fee Reminder Mailed Critical | 03 Jul, 2023 | US10471075 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 May, 2023 | US9180259 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Mar, 2023 | US8021335 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Sep, 2022 | US11446440 |
| Recordation of Patent Grant Mailed Critical | 20 Sep, 2022 | US11446440 |
| Recordation of Patent Grant Mailed Critical | 20 Sep, 2022 | US11446441 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Sep, 2022 | US11446441 |
| Email Notification Critical | 01 Sep, 2022 | US11446441 |
FDA has granted several exclusivities to Makena (autoinjector). Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Makena (autoinjector), regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Makena (autoinjector).
Exclusivity Information
Makena (autoinjector) holds 2 exclusivities. All of its exclusivities have expired in 2018. Details of Makena (autoinjector)'s exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Feb 03, 2018 |
| Orphan Drug Exclusivity(ODE-7) | Feb 03, 2018 |
Several oppositions have been filed on Makena (autoinjector)'s European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Makena (autoinjector)'s generic, the next section provides detailed information on ongoing and past EP oppositions related to Makena (autoinjector) patents.
Makena (autoinjector)'s Oppositions Filed in EPO
Makena (autoinjector) has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 07, 2019, by Bandpay & Greuter. This opposition was filed on patent number EP06719329A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP19150366A | Sep, 2022 | Bandpay & Greuter | Granted and Under Opposition |
| EP06719329A | Oct, 2019 | Bandpay & Greuter | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Makena (autoinjector) is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Makena (autoinjector)'s family patents as well as insights into ongoing legal events on those patents.
Makena (autoinjector)'s Family Patents
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Generic Launch
Generic Release Date:
Makena (autoinjector)'s generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 02, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Makena (autoinjector) Generics:
Hydroxyprogesterone Caproate is the generic name for the brand Makena (autoinjector). 6 different companies have already filed for the generic of Makena (autoinjector), with Eugia Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Makena (autoinjector)'s generic
How can I launch a generic of Makena (autoinjector) before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Makena (autoinjector)'s patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Makena (autoinjector)'s sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Makena (autoinjector) -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 275 mg/1.1 mL | 28 Sep, 2020 | 1 | 02 May, 2036 |
About Makena (autoinjector)
Makena (Autoinjector) is a drug owned by Covis Pharma Gmbh. It is used for reducing the risk of preterm birth in women with a history of singleton spontaneous preterm birth. Makena (Autoinjector) uses Hydroxyprogesterone Caproate as an active ingredient. Makena (Autoinjector) was launched by Covis in 2018.
Approval Date:
Makena (autoinjector) was approved by FDA for market use on 14 February, 2018.
Active Ingredient:
Makena (autoinjector) uses Hydroxyprogesterone Caproate as the active ingredient. Check out other Drugs and Companies using Hydroxyprogesterone Caproate ingredient
Treatment:
Makena (autoinjector) is used for reducing the risk of preterm birth in women with a history of singleton spontaneous preterm birth.
Dosage:
Makena (autoinjector) is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 275MG/1.1ML (250MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |