➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Baxter
Boehringer Ingelheim
Medtronic
McKesson

Last Updated: September 28, 2021

DrugPatentWatch Database Preview

Hydroxyprogesterone caproate - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

What are the generic drug sources for hydroxyprogesterone caproate and what is the scope of freedom to operate?

Hydroxyprogesterone caproate is the generic ingredient in five branded drugs marketed by Akorn, Allergan, Bristol Myers Squibb, Am Regent, Aspen, Aspen Global Inc, Eugia Pharma, Slayback Pharma Llc, Sun Pharm, and Covis, and is included in fifteen NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydroxyprogesterone caproate has forty-two patent family members in thirteen countries.

There are twelve drug master file entries for hydroxyprogesterone caproate. Seven suppliers are listed for this compound.

Drug Prices for hydroxyprogesterone caproate

See drug prices for hydroxyprogesterone caproate

Recent Clinical Trials for hydroxyprogesterone caproate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Bezmialem Vakif UniversityN/A
Assiut UniversityPhase 4
Aswan University HospitalN/A

See all hydroxyprogesterone caproate clinical trials

Pharmacology for hydroxyprogesterone caproate
Drug ClassProgestin
Paragraph IV (Patent) Challenges for HYDROXYPROGESTERONE CAPROATE
Tradename Dosage Ingredient NDA Submissiondate
MAKENA SOLUTION;INTRAMUSCULAR hydroxyprogesterone caproate 021945 2020-09-28
MAKENA PRESERVATIVE FREE SOLUTION;INTRAMUSCULAR hydroxyprogesterone caproate 021945 2020-09-28
MAKENA (AUTOINJECTOR) SOLUTION;SUBCUTANEOUS hydroxyprogesterone caproate 021945 2020-09-28

US Patents and Regulatory Information for hydroxyprogesterone caproate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eugia Pharma HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 211070-001 Apr 16, 2019 AP1 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Covis MAKENA hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 021945-001 Feb 3, 2011 AP1 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Bristol Myers Squibb DELALUTIN hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 016911-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Aspen HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 211777-001 Aug 8, 2019 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate INJECTABLE;INJECTION 017439-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sun Pharm HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 208381-001 Apr 9, 2019 AP1 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>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 hydroxyprogesterone caproate

Country Patent Number Estimated Expiration
Australia 2013203784 ⤷  Free Forever Trial
World Intellectual Property Organization (WIPO) 2013152323 ⤷  Free Forever Trial
Japan 6640907 ⤷  Free Forever Trial
Spain 2763633 ⤷  Free Forever Trial
World Intellectual Property Organization (WIPO) 2006079064 ⤷  Free Forever Trial
European Patent Office 1850892 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Baxter
Boehringer Ingelheim
Medtronic
McKesson

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.