Yasmin Alternatives: Exploring Generic Options and FDA-Approved Formulations
What are the available generic alternatives to Yasmin birth control pill. How does the FDA regulate and approve generic versions of Yasmin. Are generic versions of Yasmin as effective as the brand-name drug.
Understanding Yasmin and Its Generic Equivalents
Yasmin is a popular brand-name birth control pill containing drospirenone and ethinyl estradiol. As with many medications, generic versions of Yasmin have become available over time. These alternatives offer the same active ingredients and effectiveness at a potentially lower cost.
What is Yasmin?
Yasmin is an oral contraceptive pill approved by the FDA on May 11, 2001. It contains:
- 3 mg of drospirenone
- 0.03 mg of ethinyl estradiol
This combination of hormones helps prevent pregnancy when taken as directed.
Are generic versions of Yasmin available?
Yes, several FDA-approved generic versions of Yasmin exist. These contain the same active ingredients in identical amounts as the brand-name drug. Generic alternatives include products marketed under names like Syeda, Yaela, and Zumandimine, as well as versions simply labeled as “drospirenone and ethinyl estradiol.”
FDA Approval Process for Generic Yasmin
The FDA rigorously evaluates generic medications to ensure they meet the same standards of quality, safety, and efficacy as their brand-name counterparts.
How does the FDA ensure generic Yasmin equivalents are safe and effective?
The FDA requires generic manufacturers to demonstrate:
- Bioequivalence to the brand-name drug
- The same active ingredients in the same strength
- Identical dosage form and route of administration
- Adherence to strict manufacturing and quality control standards
These measures ensure that generic versions of Yasmin will work the same way in the body as the original formulation.
Manufacturers of Generic Yasmin Alternatives
Several pharmaceutical companies have received FDA approval to produce generic versions of Yasmin. This competition in the market can lead to more affordable options for consumers.
Which companies manufacture FDA-approved generic Yasmin?
Approved manufacturers include:
- Barr
- Dr. Reddy’s Laboratories
- Glenmark Pharmaceuticals
- Hetero Labs
- Lupin Ltd
- Mylan Laboratories
- Naari Pte Ltd
- Xiromed (Syeda)
- Novast Labs (Yaela)
- Aurobindo Pharma Ltd (Zumandimine)
Each of these companies has met the FDA’s stringent requirements for producing a bioequivalent version of Yasmin.
Understanding Generic Drug Labeling and Identification
Generic versions of Yasmin may look different from the brand-name pill, but they contain the same active ingredients.
How can patients identify generic Yasmin alternatives?
Generic versions of Yasmin will be labeled with:
- The active ingredients: drospirenone and ethinyl estradiol
- The strength: 3 mg/0.03 mg
- The dosage form: oral tablet
- The manufacturer’s name
Patients should always consult their healthcare provider or pharmacist if they have questions about their medication’s appearance or labeling.
Comparing Brand-Name Yasmin to Generic Alternatives
While generic versions of Yasmin contain the same active ingredients, there may be slight differences in inactive ingredients or appearance.
Do generic versions of Yasmin work the same as the brand-name drug?
Yes, FDA-approved generic versions of Yasmin are required to be just as safe and effective as the brand-name medication. The active ingredients, dosage, and mechanism of action are identical. However, some patients may notice differences in:
- Pill color or shape
- Packaging
- Inactive ingredients (which do not affect the drug’s action)
These differences do not impact the medication’s effectiveness when used as prescribed.
Cost Considerations: Brand-Name Yasmin vs. Generic Alternatives
One of the primary advantages of generic medications is their potential for cost savings.
How do the costs of generic Yasmin alternatives compare to the brand-name drug?
Generic versions of Yasmin are typically less expensive than the brand-name medication. Factors affecting cost include:
- Insurance coverage
- Pharmacy pricing
- Manufacturer discounts or coupons
- Prescription drug plans
Patients should discuss options with their healthcare provider and insurance company to find the most cost-effective choice for their needs.
Safety Considerations When Purchasing Generic Yasmin
While generic versions of Yasmin offer safe and effective alternatives, patients should be cautious when purchasing medications, especially online.
How can patients ensure they’re getting legitimate generic Yasmin?
To ensure safety and legitimacy when obtaining generic Yasmin:
- Only purchase from licensed pharmacies
- Be wary of online pharmacies offering unusually low prices
- Verify the pharmacy’s credentials through the National Association of Boards of Pharmacy
- Consult with a healthcare provider if unsure about a medication’s source
- Check that the medication’s appearance and packaging match the description provided by your pharmacist
Remember, counterfeit medications can be dangerous and ineffective. Always prioritize safety over potential cost savings.
Switching Between Brand-Name Yasmin and Generic Alternatives
Patients may consider switching from brand-name Yasmin to a generic alternative for various reasons, most commonly to reduce costs.
Is it safe to switch from brand-name Yasmin to a generic version?
Yes, it is generally safe to switch from brand-name Yasmin to an FDA-approved generic alternative. However, patients should:
- Consult their healthcare provider before making the switch
- Be aware of any potential differences in pill appearance to avoid confusion
- Report any unexpected side effects or changes in effectiveness to their healthcare provider
- Ensure they understand how to take the new medication correctly
Most patients experience no issues when switching to a generic version of Yasmin, but it’s always best to make such changes under medical supervision.
In conclusion, generic alternatives to Yasmin offer safe, effective, and potentially more affordable options for birth control. These FDA-approved medications contain the same active ingredients and undergo rigorous testing to ensure their equivalence to the brand-name drug. Patients considering a switch to generic Yasmin should discuss their options with a healthcare provider to make an informed decision based on their individual needs and circumstances.
It’s important to remember that while generic versions of Yasmin are bioequivalent to the brand-name drug, individual responses to medications can vary. Patients should always follow their healthcare provider’s instructions and report any concerns or side effects promptly. With proper use and medical supervision, generic alternatives to Yasmin can provide effective contraception and potentially offer significant cost savings.
As research in pharmaceuticals continues to advance, new formulations and alternatives may become available. Patients should stay informed about their medication options and maintain open communication with their healthcare providers to ensure they are using the most appropriate and effective contraceptive method for their individual needs.
Generic Yasmin Availability – Drugs.com
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Last updated on Jun 7, 2023.
Yasmin is a brand name of drospirenone/ethinyl estradiol, approved by the FDA in the following formulation(s):
YASMIN (drospirenone; ethinyl estradiol – tablet;oral-28)
- Manufacturer: BAYER HLTHCARE
Approval date: May 11, 2001
Strength(s): 3MG;0.03MG [RLD][AB]
Has a generic version of Yasmin been approved?
Yes. The following products are equivalent to Yasmin:
DROSPIRENONE AND ETHINYL ESTRADIOL (drospirenone; ethinyl estradiol tablet;oral-28)
- Manufacturer: BARR
Approval date: May 9, 2008
Strength(s): 3MG;0.03MG [AB] - Manufacturer: DR REDDYS LABS SA
Approval date: September 7, 2010
Strength(s): 3MG;0.03MG [AB] - Manufacturer: GLENMARK PHARMS LTD
Approval date: March 25, 2016
Strength(s): 3MG;0.03MG [AB] - Manufacturer: HETERO LABS
Approval date: January 24, 2020
Strength(s): 3MG;0. 03MG [AB] - Manufacturer: LUPIN LTD
Approval date: December 18, 2012
Strength(s): 3MG;0.03MG [AB] - Manufacturer: MYLAN LABS LTD
Approval date: May 4, 2015
Strength(s): 3MG;0.03MG [AB] - Manufacturer: NAARI PTE LTD
Approval date: November 22, 2016
Strength(s): 3MG;0.03MG [AB]
SYEDA (drospirenone; ethinyl estradiol tablet;oral-28)
- Manufacturer: XIROMED
Approval date: March 28, 2011
Strength(s): 3MG;0.03MG [AB]
YAELA (drospirenone; ethinyl estradiol tablet;oral-28)
- Manufacturer: NOVAST LABS
Approval date: November 19, 2014
Strength(s): 3MG;0.03MG [AB]
ZUMANDIMINE (drospirenone; ethinyl estradiol tablet;oral-28)
- Manufacturer: AUROBINDO PHARMA LTD
Approval date: March 26, 2018
Strength(s): 3MG;0.03MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Yasmin. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
More about Yasmin (drospirenone / ethinyl estradiol)
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Glossary
Term | Definition |
---|---|
Drug Patent | A drug patent is assigned by the U. S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
Yasmin Alternatives Compared – Drugs.com
Yasmin Alternatives Compared – Drugs.com
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Prescription only Prescribed for Premenstrual Dysphoric Disorder, Acne, Birth Control. Yasmin may also be used for purposes not listed in this medication guide. | </p> <p> Mirena may also be used for purposes not listed in this comparison guide. </p> ”> | </p> ”> | Related suggestions Birth Control (Contraception)
Popular comparisons
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More about Yasmin (drospirenone / ethinyl estradiol) | More about Mirena (levonorgestrel) | More about Nexplanon (etonogestrel) | ||||||||||||||||||||||||
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Lower-cost generic is available | Lower-cost generic is available | No lower-cost generic available | ||||||||||||||||||||||||
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Yasmin has an average rating of | Mirena has an average rating of | Nexplanon has an average rating of | ||||||||||||||||||||||||
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See also: Yasmin side effects in more detail. | See also: Mirena side effects in more detail. | Common side effects include:
See also: Nexplanon side effects in more detail. | ||||||||||||||||||||||||
Pricing and Coupons * Prices are without insurance | ||||||||||||||||||||||||||
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Half Life The half-life of a drug is the time taken for the plasma concentration of a drug to reduce to half its original value. | ||||||||||||||||||||||||||
32.5 hours | 45 hours | 25 hours | ||||||||||||||||||||||||
CSA Schedule ** View glossary of terms | ||||||||||||||||||||||||||
Is not subject to the Controlled Substances Act. | Is not subject to the Controlled Substances Act. | Is not subject to the Controlled Substances Act. | ||||||||||||||||||||||||
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See the full pregnancy warnings document. | See the full pregnancy warnings document. | See the full pregnancy warnings document. | ||||||||||||||||||||||||
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A total of 536 drugs are known to interact with Yasmin:
| A total of 239 drugs are known to interact with Mirena:
| A total of 226 drugs are known to interact with Nexplanon:
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No known alcohol/food interactions. This does not necessarily mean no interactions exist. Always consult your healthcare provider. |
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WADA Class View World Anti-Doping Agency classifications. | ||||||||||||||||||||||||||
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** The Controlled Substances Act (CSA) schedule information displayed applies to substances regulated under federal law. There may be variations in CSA schedules between individual states.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
Results of pharmacoeconomic studies on drugs Jess and Yarin
All articles
08/18/2021
Premenstrual disorders are widespread among women all over the world. These violations significantly reduce the quality of life, social activity, as well as the efficiency of women’s work. The most severe are premenstrual syndrome (PMS) and premenstrual dysphoric disorders (PMDD).
Therapy of these disorders is extremely important. The results of the study [1] indicate that patients with moderate to severe manifestations of PMS/PMDD during one menstrual cycle cannot perform 8 hours more (1 working day) than patients with mild manifestations of PMS/PMDD or without PMS/PMDD. Also, according to the complication severity questionnaire, in the group of patients with moderate and severe manifestations of PMS/PMDD, the state of reduced working capacity and social activity (observation – 2 months) lasted 4. 5 days longer than in the group of patients without PMS/PMDD or with mild degree (5.6 days versus 1.1 days). The findings of this study are supported by data from the IMPACT and Extension studies.
Comparative treatment efficacy studies PMS / PMDD between Yasmin 9 0014 and competitors
Another indication for prescribing drospirenone-containing drugs is contraception. According to the results of modern research, all oral contraceptives have comparable efficacy and safety profiles. Therefore, the standard design of a pharmacoeconomic study in this case will not be informative. To take into account the overall complex of positive effects of drospirenone-containing contraceptives, a joint analysis was carried out [3]. Parameters assessed included dosage tolerance, weight gain, effects on skin and hair, effects on premenstrual syndromes, menstrual bleeding, and drug cost. An overall utility index of the studied alternatives was derived (Yasmin, EE 30 + DSG 150, EE 20 + DSG 150). As a result of the survey, it was found that Yasmin has an advantage over comparators in all additional parameters (in terms of tolerability, as well as indicators of weight gain, effects on the skin and hair, premenstrual syndromes and menstrual bleeding). The analysis showed that in order to receive an additional unit of benefit when using Yasmin, it is necessary to spend an additional 19€2 compared to EE 30 + DSG 150 and €104.82 compared to EE 20 + DSG 150. The study was conducted in Portugal.
To assess the budgetary impact of Yasmin in terms of unwanted pregnancies avoided, a pharmacoeconomic study was conducted in Scotland. In a simulation with a time horizon of 6 years, Yasmin prevented an additional 995 unwanted pregnancies compared to other non-oral contraceptive methods. The cost of preventing one additional unwanted pregnancy was £72.
The results of pharmacoeconomic studies show that the use of Yasmin provides both a wide range of contraceptive and non-contraceptive positive effects and is economically justified.
Literature
- Heinemann L.A.J. et al. Explorative evaluation of the impact of severe premenstrual disorders on work absenteeism and productivity. Women’s Health Issues 20 (2010), pp 58-65
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