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 in its drug Delalutin on Approved Prior to Jan 1, 1982. Other drugs containing Hydroxyprogesterone Caproate are Makena, Makena (Autoinjector), Hydroxyprogesterone Caproate, Makena Preservative Free. 12 different companies have introduced drugs containing Hydroxyprogesterone Caproate.


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) US9844558 Methods of reducing risk of preterm birth May 02, 2036 Covis
Makena (autoinjector) US9789257 Needle assisted injection device having reduced trigger force Feb 11, 2034 Covis
Makena (autoinjector) US11446440 Needle assisted injection device having reduced trigger force Aug 21, 2031 Covis
Makena (autoinjector) US8021335 Prefilled syringe jet injector Oct 04, 2026 Covis
Makena (autoinjector) US11446441 Prefilled syringe injector Jan 24, 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) USRE44846 Needle assisted jet injector Aug 10, 2019

(Expired)

Covis



Hydroxyprogesterone Caproate's Family Patents

Family Patents

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Hydroxyprogesterone Caproate Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


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. 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


Manufacturing Plant Locations
New

Aspen's manufacturing plants are situated in 6 countries - United States, Germany, France, Netherlands, Ireland, South Africa. Given below are the details of these plant locations as well as the firm names of Aspen as present at those locations.

Country City Firm Name
United States
Garner Aspen Hills, Inc.
Billings Aspen Air US LLC
Bedminster Aspen Sales Group
Aurora Aspen Distribution, Incorporated
Obetz Aspen Distribution Inc
Aspen Aspen Valley Hospital
Caledonia Aspen Surgical Products, Inc.
Denver Aspen Pure
Aspen Aspen Station/Aspen Pitkin County Airport
Aspen Aspen Brownie Works LLC
Arden Aspen Surgical Products Inc
Georgetown Aspen Park Candies, Inc.
Stillwater Aspen Coffee Company
Las Piedras Aspen Surgical Puerto Rico Corp.
Lindon Aspen Co-Pak, LLC
Des Plaines Aspen API Inc
Gonzales Aspen Beverage Enterprises Limited - Gonzales (dba Finlays - Gonzales)
Germany
Bad Oldesloe Aspen Bad Oldesloe Gmbh
France
Notre Dame de Bondeville Aspen Notre Dame de Bondeville
Netherlands
Oss Aspen Oss B.V.
Ireland
Dublin 24 Aspen Pharma Trading Ltd.
South Africa
Port Elizabeth Aspen SA Sterile Operations (Pty) Ltd.
Korsten Aspen SA OSD Operations Pty Ltd.





3. 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





4. 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


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Pashamylaram Eugia Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited





5. 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





6. 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


Manufacturing Plant Locations
New

Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.

Country City Firm Name
United States
Lexington Sun Pharmaceutical Industries Inc
Billerica Sun Pharmaceutical Industries, Inc.
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
India
Halol Sun Pharmaceutical Industries Ltd.
New Delhi Sun Pharmaceutical Industries Limited
Punjab Sun Pharmaceutical Industries, Inc.
Ahmednagar Sun Pharmaceutical Industries Limited
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Mohali Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Baruch Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Dadra Sun Pharmaceutical Industries Limited
Bharuch Sun Pharmaceutical Industries Ltd