Ganirelix Acetate Patent Expiration

Ganirelix Acetate is Used for preventing premature LH surges in women undergoing controlled ovarian hyperstimulation with FSH. It was first introduced by Organon Usa Llc A Sub Of Organon And Co in its drug Ganirelix Acetate on Jul 29, 1999. 6 different companies have introduced drugs containing Ganirelix Acetate.


Ganirelix Acetate Patents

Given below is the list of patents protecting Ganirelix Acetate, 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
Ganirelix Acetate US6653286 Gonadotropin releasing hormone antagonist Jun 16, 2018

(Expired)

Organon Usa Organon
Ganirelix Acetate US5767082 Nonapeptide and decapeptide analogs of LHRH useful as LHRH antagonists Jun 16, 2015

(Expired)

Organon Usa Organon



Ganirelix Acetate's Family Patents

Family Patents

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Ganirelix Acetate Generic API Manufacturers

Several generic applications have been filed for Ganirelix Acetate. The first generic version for Ganirelix Acetate was by Sun Pharmaceutical Industries Ltd and was approved on Nov 30, 2018. And the latest generic version is by Lupin Ltd and was approved on Nov 16, 2023.

Given below is the list of companies who have filed for Ganirelix Acetate generic, along with the locations of their manufacturing plants worldwide.


1. AMPHASTAR PHARMS INC

Amphastar Pharmaceuticals Inc has filed for 1 generic for Ganirelix Acetate. Given below are the details of the strengths of this generic introduced by Amphastar Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MCG/0.5ML

injectable Prescription INJECTION AP Apr 7, 2022





2. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 1 generic for Ganirelix Acetate. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MCG/0.5ML

injectable Prescription INJECTION AP Feb 28, 2023





3. LUPIN LTD

Lupin Ltd has filed for 1 generic for Ganirelix Acetate. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MCG/0.5ML

injectable Prescription INJECTION AP Nov 16, 2023


Manufacturing Plant Locations
New

Lupin Ltd'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 Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





4. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Ganirelix Acetate. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MCG/0.5ML

injectable Prescription INJECTION AP Jun 6, 2022





5. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 1 generic for Ganirelix Acetate. This 250mcg/0.5ml version comes by the name FYREMADEL. 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
250MCG/0.5ML

injectable Prescription INJECTION AP Nov 30, 2018


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