Hydroxyprogesterone Caproate Patent Expiration
Hydroxyprogesterone Caproate is used for reducing the risk of preterm birth in women with a history of singleton spontaneous preterm birth. It was first introduced by Bristol Myers Squibb
Hydroxyprogesterone Caproate Patents
Given below is the list of patents protecting Hydroxyprogesterone Caproate, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Makena (autoinjector) | US10471075 | Methods of reducing risk of preterm birth | May 02, 2036 | Covis |
| Makena (autoinjector) | US11154562 | Methods of reducing risk of preterm birth | May 02, 2036 | Covis |
| Makena (autoinjector) | US11304962 | Methods of reducing risk of preterm birth | May 02, 2036 | Covis |
| Makena (autoinjector) | US11446440 | Needle assisted injection device having reduced trigger force | Aug 21, 2031 | Covis |
| Makena (autoinjector) | US11446441 | Prefilled syringe injector | Jan 24, 2026 | Covis |
| Makena (autoinjector) | US8021335 | Prefilled syringe jet injector | Oct 04, 2026 | Covis |
| Makena (autoinjector) | US8562564 | Prefilled syringe jet injector | Jan 24, 2026 | Covis |
| Makena (autoinjector) | US9180259 | Prefilled syringe jet injector | Jan 24, 2026 | Covis |
| Makena (autoinjector) | US9533102 | Prefilled syringe jet injector | Jan 24, 2026 | Covis |
| Makena (autoinjector) | US9629959 | Prefilled syringe jet injector | Jan 24, 2026 | Covis |
| Makena (autoinjector) | US9789257 | Needle assisted injection device having reduced trigger force | Feb 11, 2034 | Covis |
| Makena (autoinjector) | US9844558 | Methods of reducing risk of preterm birth | May 02, 2036 | Covis |
| Makena (autoinjector) | USRE44846 | Needle assisted jet injector |
Aug 10, 2019
(Expired) | Covis |
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Hydroxyprogesterone Caproate Generics
Several generic applications have been filed for Hydroxyprogesterone Caproate. The first generic version for Hydroxyprogesterone Caproate was by Aspen Global Inc and was approved on Aug 24, 2015. And the latest generic version is by American Regent Inc and was approved on Aug 9, 2019.
Given below is the list of companies who have filed for Hydroxyprogesterone Caproate generic.
1. AM REGENT
American Regent Inc has filed for 2 different strengths of generic version for Hydroxyprogesterone Caproate. Given below are the details of the strengths of this generic introduced by Am Regent.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/ML (250MG/ML) | solution | Prescription | INTRAMUSCULAR | AP | Jun 21, 2018 |
| 1250MG/5ML (250MG/ML) | solution | Discontinued | INTRAMUSCULAR | N/A | Aug 9, 2019 |
2. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 1 generic for Hydroxyprogesterone Caproate. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1250MG/5ML (250MG/ML) | solution | Prescription | INTRAMUSCULAR | AP1 | Apr 9, 2019 |
3. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 2 different strengths of generic version for Hydroxyprogesterone Caproate. Given below are the details of the strengths of this generic introduced by Eugia Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1250MG/5ML (250MG/ML) | solution | Discontinued | INTRAMUSCULAR | N/A | May 9, 2019 |
| 250MG/ML (250MG/ML) | solution | Prescription | INTRAMUSCULAR | AP | Apr 16, 2019 |
4. SLAYBACK PHARMA LLC
Slayback Pharma Llc has filed for 2 different strengths of generic version for Hydroxyprogesterone Caproate. Given below are the details of the strengths of this generic introduced by Slayback Pharma Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1250MG/5ML (250MG/ML) | solution | Prescription | INTRAMUSCULAR | AP1 | Dec 28, 2018 |
| 250MG/ML (250MG/ML) | solution | Prescription | INTRAMUSCULAR | AP | Mar 22, 2019 |
5. ASPEN
Aspen Pharma Usa Inc has filed for 1 generic for Hydroxyprogesterone Caproate. Given below are the details of the strengths of this generic introduced by Aspen.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/ML (250MG/ML) | solution | Prescription | INTRAMUSCULAR | AP | Aug 8, 2019 |
6. ASPEN GLOBAL INC
Aspen Global Inc has filed for 1 generic for Hydroxyprogesterone Caproate. Given below are the details of the strengths of this generic introduced by Aspen Global Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1250MG/5ML (250MG/ML) | solution | Discontinued | INTRAMUSCULAR | N/A | Aug 24, 2015 |